Cognitive behavioral therapy for insomnia enhances depression outcome in patients with comorbid major depressive disorder and insomnia
Open accessAbstract
STUDY OBJECTIVE: Insomnia impacts the course of major depressive disorder (MDD), hinders response to treatment, and increases risk for depressive relapse. This study is an initial evaluation of adding cognitive behavioral therapy for insomnia (CBTI) to the antidepressant medication escitalopram (EsCIT) in individuals with both disorders. DESIGN AND SETTING: A randomized, controlled, pilot study in a single academic medical center. PARTICIPANTS: 30 individuals (61% female, mean age 35 +/- 18) with MDD and insomnia. INTERVENTIONS: EsCIT and 7 individual therapy sessions of CBTI or CTRL (quasi-desensitization). MEASUREMENTS AND RESULTS: Depression was assessed with the HRSD17 and the depression portion of the SCID, administered by raters masked to treatment assignment, at baseline and after 2, 4, 6, 8, and 12 weeks of treatment. The primary outcome was remission of MDD at study exit, which required both an HRSD17 score < or =7 and absence of the 2 core symptoms of MDD. Sleep was assessed with the insomnia severity index (ISI), daily sleep diaries, and actigraphy. EsCIT + CBTI resulted in a higher rate of remission of depression (61.5%) than EsCIT + CTRL (33.3%). EsCIT + CBTI was also associated with a greater remission from insomnia (50.0%) than EsCIT + CTRL (7.7%) and larger improvement in all diary and actigraphy measures of sleep, except for total sleep time. CONCLUSIONS: This pilot study provides evidence that augmenting an antidepressant medication with a brief, symptom focused, cognitive-behavioral therapy for insomnia is promising for individuals with MDD and comorbid insomnia in terms of alleviating both depression and insomnia.
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TL;DR
In a randomized pilot of 30 adults with major depressive disorder (MDD) and insomnia, adding cognitive behavioral therapy for insomnia (CBTI) to escitalopram produced higher depression remission (61.5%) than escitalopram plus control therapy (33.3%). The authors conclude that augmenting an antidepressant with brief CBTI is promising for both depression and insomnia, but requires replication.
Key findings
- Depression remission at study exit—defined as HRSD-17 score ≤ 7 plus absence of the two core MDD symptoms—was 61.5% for EsCIT + CBTI versus 33.3% for EsCIT + CTRL; the difference was not statistically significant (P = 0.13 for a one-tailed Fisher exact test).
- Insomnia remission (ISI score ≤ 7) was 50.0% with EsCIT + CBTI versus 7.7% with EsCIT + CTRL (χ² = 5.7, P = 0.05). In the whole sample, 83% of those whose insomnia remitted also remitted from depression, versus 39% of those whose insomnia did not remit (χ² = 3.6, P = 0.08).
- EsCIT + CBTI showed larger improvement in all diary and actigraphy sleep measures except total sleep time; the largest effect sizes were for diary sleep efficiency (Cohen’s d = 0.76) and ISI (Cohen’s d = 1.03). Endpoint HRSD-17 was 7.9 (6.6) for CBTI versus 11.0 (8.7) for CTRL; HRSD-17 minus sleep items was 5.8 (5.6) versus 8.8 (7.3).
- Patient expectation by treatment interaction was significant (Wald = 4.5, P = 0.033): in CTRL, 0% (0/9) with low expectation remitted versus 83% (5/6) with high expectation; in CBTI, 80% (4/5) with low expectation remitted versus 43% (3/7) with high expectation. Therapists’ expectations were higher for CBTI (4.5 [0.49]) than CTRL (3.5 [0.84]; P = 0.002).
Methods
- Randomized, controlled pilot study at a single academic medical center. Thirty participants with MDD and insomnia were randomized to 12 weeks of open-label escitalopram plus 7 individual sessions of CBTI (n = 15) or control quasi-desensitization therapy (CTRL; n = 15); the analyzable sample was 13 in EsCIT + CBTI and 15 in EsCIT + CTRL.
- Inclusion required DSM-IV-TR MDD, HRSD-17 score ≥ 14, and DSM-IV-TR insomnia by Duke Structured Interview plus diary criteria; exclusions included active suicidality/psychosis, seasonal MDD, comorbid psychiatric conditions, other primary sleep disorders, and incompatible medical conditions.
- Depression was assessed by masked raters using HRSD-17 and the SCID depression portion at baseline and weeks 2, 4, 6, 8, and 12. Sleep was assessed with the Insomnia Severity Index, daily sleep diaries, and actigraphy; analyses included remission rates, effect sizes, Fisher exact tests, chi-square tests, and logistic regression for expectations.
Limitations
- The authors state the results are tentative because this was a pilot study with a small sample, relative homogeneity in racial distribution, exclusion of patients with comorbidity, and need for replication in larger samples and with a range of antidepressant medications.
- The authors state the small sample precludes a meaningful mediation analysis of whether sleep improvement mediates differential depression remission.
- The authors note that differential therapists’ expectations and patient expectations may have confounded findings, and recommend future research use different therapists for CBTI and CTRL or an alternative control therapy. Evident from the text: baseline age is inconsistently reported (abstract mean age 35 ± 18 vs. Table 1 total age 48.6 ± 13.3), and analyzable group sizes vary across the flow diagram and Table 2.
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Claims the paper makes
0 of 28 cited sources checked · 0 supported · 0 flagged
- Findingown data
EsCIT + CBTI was associated with larger improvement in all diary and actigraphy measures of sleep, except for total sleep time, compared to EsCIT + CTRL.
“EsCIT + CBTI was also associated with a greater remission from insomnia (50.0%) than EsCIT + CTRL (7.7%) and larger improvement in all diary and actigraphy measures of sleep, except for total sleep time.”
Quote in the paperSubstantial claim - Findingown data
EsCIT + CBTI was associated with a greater remission from insomnia (50.0%) than EsCIT + CTRL (7.7%).
“EsCIT + CBTI was also associated with a greater remission from insomnia (50.0%) than EsCIT + CTRL (7.7%)”
Quote in the paperSubstantial claim - Findingown data
Compliance with CBTI was not significantly correlated with changes in sleep (P = 0.13 for the diary rating of sleep quality and P-values ≥ 0.5 for changes in all other sleep diary variables and for the change in ISI).
“Compliance with CBTI was not significantly correlated with changes in sleep (P = 0.13 for the diary rating of sleep quality and P-values ≥ 0.5 for changes in all other sleep diary variables and for the change in ISI).”
Quote in the paperNot a substantial claim - Findingown data
For participants receiving EsCIT + CBTI, the correlation between the therapists' ratings of patients' compliance with CBTI instructions and the change in HRSD 17 score from baseline to the last available observation was 0.61 (P = 0.07).
“For participants receiving EsCIT + CBTI, the correlation between the therapists' ratings of patients' compliance with CBTI instructions and the change in HRSD 17 score from baseline to the last available observation was 0.61 (P = 0.07).”
Quote in the paperNot a substantial claim - Findingown data
Patients' expectations of sleep benefit did not differ significantly between EsCIT+CBTI and EsCIT+CTRL (t=0.88, P=0.39, Cohen's-d=0.34).
“Participants' expectations of sleep benefit, measured at the end of session 2 as the mean of the item z-scores, were -0.45 (0.64) for EsCIT + CBTI and -0.68 (0.70) for EsCIT + CTRL.The difference did not reach statistical significance (t = 0.88; P = 0.39; Cohen's-d = 0.34).”
Quote in the paperNot a substantial claim
- Findingown data
In the CTRL treatment, a greater remission rate was observed in those with expectations above the sample median compared to those whose expectations were below the median.
“In the CTRL treatment a greater remission rate was observed in those with expectations above the sample median compared to those whose expectations were below the median.”
Quote in the paperNot a substantial claim - Findingown data
Therapists' expectations of benefit were significantly higher for participants in the EsCIT+CBTI group (4.5±0.49) than for those in the EsCIT+CTRL group (3.5±0.84) (t=3.5, P=0.002, Cohen's-d=1.31).
“Therapists' expectations of benefit were significantly higher for participants in the EsCIT + CBTI group, 4.5 (0.49), than for those in the EsCIT + CTRL group, 3.5 (0.84) for CTRL (t = 3.5; P = 0.002; Cohen's-d = 1.31)”
Quote in the paperNot a substantial claim - Findingown data
The largest effect sizes were observed for the improvement in diary-based sleep efficiency (SE) and the insomnia severity index (ISI).
“The largest effect sizes were observed for the improvement in diary based sleep efficiency (SE) and the insomnia severity index (ISI).”
Quote in the paperNot a substantial claim - Findingown data
The rate of remission from MDD was markedly higher for those treated with EsCIT + CBTI (62%) than in those treated with EsCIT + CTRL (33%).
“we found that the rate of remission from MDD was markedly higher for those treated with EsCIT + CBTI (62%) than in those treated with EsCIT + CTRL (33%).”
Quote in the paperSubstantial claim - Findingown data
In the CBTI group, a somewhat greater remission rate was observed in those with lower expectations compared to those with higher than median expectations.
“In contrast, in the CBTI group a somewhat greater remission rate was observed in those with lower expectations compared to those with higher than median expectations.”
Quote in the paperNot a substantial claim - Findingown data
Exploratory analysis using split median revealed that patients' expectations might have played a greater role in the CTRL treatment than in CBTI.
“Our exploratory analysis, using split median, revealed that patients' expectations might have played a greater role in the CTRL treatment than in CBTI.”
Quote in the paperNot a substantial claim - Findingown data
Treatment with EsCIT + CBTI was associated with a higher rate of remission of insomnia (50% vs 8% by ISI) than treatment with EsCIT + CTRL.
“Treatment with EsCIT + CBTI was associated with a higher rate of remission of insomnia (50%), defined by the ISI, than treatment with EsCIT + CTRL (8%).”
- Also stated in: § Enhancing Depression Outcome in MDD and Insomnia-Manber et al dIsCUssIon · plain
“The proportion of participants who achieved insomnia remission (ISI score ≤ 7) at the last available observation was 50.0% in the EsCIT + CBTI group and 7.7% in the EsCIT + CTRL group (χ 2 = 5.7, P = 0.05).”
Quote in the paperSubstantial claim - Also stated in: § Enhancing Depression Outcome in MDD and Insomnia-Manber et al dIsCUssIon · plain
- Interpretationown data
Augmenting an antidepressant medication with a brief, symptom-focused CBTI is promising for individuals with MDD and comorbid insomnia in terms of alleviating both depression and insomnia.
“This pilot study provides evidence that augmenting an antidepressant medication with a brief, symptom focused, cognitivebehavioral therapy for insomnia is promising for individuals with MDD and comorbid insomnia in terms of alleviating both depression and insomnia.”
Quote in the paperSubstantial claim - Premisecitation
Depressed patients with abnormal sleep profiles have significantly poorer clinical outcomes with respect to symptom ratings, attrition and remission rates, and the stability of response to treatment than those with more normal sleep profiles.
“Depressed patients with abnormal sleep profiles have significantly poorer clinical outcomes with respect to symptom ratings, attrition and remission rates, and the stability of response to treatment than those with more normal sleep profiles.2,4”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [2]
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- cites [4]
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- Premisecitation
CBTI produces improvements in primary insomnia equivalent to those achieved during acute treatment with hypnotic medications in terms of reducing nocturnal wakefulness, increasing sleep efficiency, and improving subjective sleep quality.
“Extensive research summarized in several meta-analyses [14][15][16][17] has shown that CBTI produces improvements in primary insomnia equivalent to those achieved during acute treatment with hypnotic medications 18,19 in terms of reducing nocturnal wakefulness, increasing sleep efficiency, and improving subjective sleep quality.14,20”
Quote in the paperNot a substantial claim0 of 5 sources checked- cites [14][15][16][17]
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- cites [18]
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- cites [19]
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- cites [14]
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- cites [20]
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- Premisecitation
Sleep improvements achieved during CBTI endure up to 2 years after the course of CBTI is completed.
“Most important, sleep improvements achieved during CBTI endure up to 2 years after the course of CBTI is completed.26”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [26]
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- Interpretationcitation
Insomnia symptoms hinder response to antidepressant treatment.
“Collectively, these findings indicate that insomnia symptoms hinder response to antidepressant treatment.”
Quote in the paperSubstantial claim - Premisecitation
Sleep difficulties are common residual symptoms in individuals who have responded to depression treatment.
“Sleep difficulties are also common residual symptoms in individuals who have responded to depression treatment.[6][7][8][9][10]”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [6][7][8][9][10]
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- Premisecitation
Patients with MDD who experience sleep continuity disturbance and early morning awakening are more likely to have suicidal ideation than those without such disturbances.
“Patients with MDD who experience sleep continuity disturbance and early morning awakening are also more likely to have suicidal ideation than those without such disturbances.5”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [5]
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- Premisecitation
Subjective and objective sleep disturbances are associated with slower and lower rates of remission from depression.
“Subjective and objective (electroencephalographic) sleep disturbances are associated with slower and lower rates of remission from depression.[1][2][3]”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [1][2][3]
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- Premisecitation
Continued insomnia following the acute phase of antidepressant therapy poses a significant risk for relapse.
“Continued insomnia following the acute phase of antidepressant therapy poses a significant risk for relapse.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [11]
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- Premisecitation
Sleep disturbance does not always resolve with antidepressant treatment.
“Sleep disturbance does not always resolve with antidepressant treatment.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [6][7][8][9][10]
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- Premisecitation
CBTI is effective for insomnia that is comorbid with depression.
“There is also some evidence that CBTI is effective for insomnia that is comorbid with depression.[21][22][23][24][25]”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [21][22][23][24][25]
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- Premisecitation
Patients who remain insomnia free are likely to remain depression free for longer periods of time than those whose insomnia recurs.
“This attribute of CBTI is particularly important in the context of depression, as patients who remain insomnia free are likely to remain depression free for longer periods of time than those whose insomnia recurs.12,27”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [12]
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- cites [27]
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- Interpretationown data
The substantially higher remission rate of insomnia among those treated with EsCIT + CBTI suggests that CBTI improves sleep above and beyond any improvement associated with the antidepressant medication itself.
“The substantially higher remission rate of insomnia among those treated with EsCIT + CBTI suggests that CBTI improves sleep above and beyond any improvement associated with the antidepressant medication itself.”
Quote in the paperSubstantial claim - Interpretationown data
The mechanism by which augmentation of the SSRI escitalopram with a brief insomnia therapy enhances antidepressant response cannot be discerned from this pilot study.
“The mechanism by which augmentation of the SSRI escitalopram with a brief insomnia therapy enhances antidepressant response cannot be discerned from this pilot study.”
Quote in the paperNot a substantial claim - Interpretationreasoning
The two treatments have differentially affected non-sleep symptoms of MDD.
“Thus, it appears that the two treatments have differentially affected non-sleep symptoms of MDD.”
Quote in the paperSubstantial claim - Interpretationown data
CBTI is relatively easy to disseminate.
“We also found that CBTI is relatively easy to disseminate.”
Quote in the paperNot a substantial claim - Interpretationown data
Together these findings suggest that nonspecific therapeutic factors were more likely to have impacted outcome in the CTRL group than in the CBTI group.
“Together these findings suggest that nonspecific therapeutic factors were more likely to have impacted outcome in the CTRL group than in the CBTI group.”
Quote in the paperNot a substantial claim - Interpretationreasoning
The large group difference in the rate of remission from MDD suggests that the 2 therapies differed in their impact on the core symptoms of MDD (sadness and anhedonia), as the absence of both symptoms was required before remission status can be determined.
“Specifically, the large group difference in the rate of remission from MDD suggests that the 2 therapies differed in their impact on the core symptoms of MDD (sadness and anhedonia), as the absence of both symptoms was required before remission status can be determined.”
Quote in the paperSubstantial claim - Interpretationown data
This pilot study provides evidence that augmenting an antidepressant medication with a brief, symptom-focused cognitive-behavioral therapy for insomnia is promising for individuals with MDD and comorbid insomnia.
“This pilot study provides evidence that the strategy of augmenting an antidepressant medication with a brief, symptom focused cognitive-behavioral therapy for insomnia is promising for individuals with MDD and comorbid insomnia.”
Quote in the paperSubstantial claim - Study design and conductown data
The small sample size precludes a meaningful test of the possibility that the observed differential remission of MDD is mediated by the differential improvement in sleep.
“The small sample size precludes a meaningful test of the possibility that the observed differential remission of MDD is mediated by the differential improvement in sleep.”
Quote in the paperSubstantial claim - Study design and conductown data
There were no group differences in any of the baseline variables depicted in Table 1.
“There were no group differences in any of the baseline variables depicted in Table 1.”
Quote in the paperNot a substantial claim - Interpretationown data
Two findings from this study suggest that the magnitude of the difference in improvement of depression exceeds what would be expected from the differential improvement in sleep alone.
“Two findings from this study suggest that the magnitude of the difference in improvement of depression exceeds what would be expected from the differential improvement in sleep alone.”
Quote in the paperSubstantial claim - Premisecitation
Remission of insomnia as measured by the ISI was 17% higher in the group receiving the two active drugs (50% versus 33%).
“Remission of insomnia as measured by the ISI was 17% higher in the group receiving the two active drugs (50% versus 33%).”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [44]
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- Premisecitation
Past research that compared CBTI with the same CTRL therapy used in the present study has successfully maintained equivalent credibility for both therapies when delivered by new therapists with no experience in CBTI.
“Past research that compared CBTI with the same CTRL therapy used in the present study has successfully maintained equivalent credibility for both therapies when delivered by new therapists with no experience in CBTI.45”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [45]
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- May combine two claims. 18
- The quote only partly states this claim. 3
- Classified as probably not a substantial claim. 29
May combine two claims. The quote only partly states this claim.
Findingown dataChange in ISI scores was significantly correlated with patients' expectation of sleep benefits (r = 0.49, P = 0.015), with higher expectations associated with greater reductions in ISI scores.
“The correlation between change in ISI scores and patients' expectation of sleep benefits was significant (r = 0.49, P = 0.015).”
- Also stated in: § Enhancing Depression Outcome in MDD and Insomnia-Manber et al dIsCUssIon · plain
“Higher expectations of benefit were associated greater reductions in ISI scores.”
Quote in the paperNot a substantial claim- Also stated in: § Enhancing Depression Outcome in MDD and Insomnia-Manber et al dIsCUssIon · plain
May combine two claims.
Findingown dataIn a logistic regression model with remission status as dependent variable, the overall model fit was significant (χ2=9.4, P=0.024), and only the interaction term between treatment group and patient expectations was significant (Wald=4.5, P=0.033).
“To test the impact of patients' expectations on the main outcome we tested a logistic regression model with remission status as the dependent variable.The predictors included treatment group, patient expectations, both centered, and their interaction.The overall model fit was significant (χ 2 = 9.4,P = 0.024).Of the variables in the model only the interaction term was significant (Wald = 4.5, P =”
Quote in the paperSubstantial claimMay combine two claims.
Findingown dataAmong those whose insomnia remitted, 83% also experienced remission of depression, whereas among those whose insomnia did not remit, only 39% experienced remission of depression (χ2 = 3.6, P = 0.08).
“Among those whose insomnia remitted 83% also experienced remission of depression, whereas among those whose insomnia did not remit only 39% experienced remission of depression (χ 2 = 3.6, P = 0.08).”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingown dataTherapists' expectations were significantly correlated with patients' expectations (r=0.40, P<0.05).
“and were significantly correlated with patients' expectations (r = 0.40, P < 0.05).”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingown dataIn 3 months, 2 general psychotherapists naive to sleep medicine and insomnia therapy were successfully trained to deliver both CBTI and CTRL.
“In 3 months we successfully trained 2 general psychotherapists naive to sleep medicine and insomnia therapy to deliver both CBTI and CTRL.”
Quote in the paperNot a substantial claimMay combine two claims. The quote only partly states this claim.
Findingown dataIn the EsCIT+CTRL group, 0% (0/9) of those with low expectation attained remission and 83% (5/6) of those with high expectations attained remission; in the EsCIT+CBTI group, 80% (4/5) of those with low expectation remitted and only 43% (3/7) of those with high expectation remitted.
“Follow up examination of the 4 subgroups based on split median of all patients' expectations (CBTI-Low expectation, CBTI-High expectation, CTRL-Low expectation, CTRL-High Expectation) revealed that expectations played a significant role in the EsCIT + CTRL group, with 0% (0/9) of those with low expectation attaining remission status and 83% (5/6) of those with high expectations attaining remission”
Quote in the paperSubstantial claimClassified as probably not a substantial claim.
Study design and conductnone givenDepression was assessed with the HRSD 17 and the depression portion of the SCID by raters masked to treatment assignment at baseline and after 2, 4, 6, 8, and 12 weeks of treatment.
“Depression was assessed with the HRSD 17 and the depression portion of the SCID, administered by raters masked to treatment assignment, at baseline and after 2, 4, 6, 8, and 12 weeks of treatment.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationInsomnia may be a first-occurring prodromal symptom in previously depression-remitted persons.
“Additionally, there are indications that insomnia may be a first-occurring prodromal symptom in previously depression-remitted persons.12”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [12]
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Study design and conductown dataThe study was a randomized, controlled, pilot study in a single academic medical center.
“A randomized, controlled, pilot study in a single academic medical center.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductnone givenRandomization was performed in blocks of 2 and separate randomization tables were created for individuals with HRSD 17 scores above and below 20 to ensure equal distribution of depression severity in the two conditions.
“Randomization was performed in blocks of 2 and separate randomization tables were created for individuals with HRSD 17 scores above and below 20 to ensure equal distribution of depression severity in the two conditions.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenTreatment allocation was concealed from the principal investigator and all other investigators and personnel, except for the study coordinator, who assigned participants to their groups.
“Treatment allocation was concealed from the principal investigator and all other investigators and personnel, except for the study coordinator, who assigned participants to their groups”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationWith time, conditioned insomnia develops and persists even after the stressor is removed; anxiety about not being able to sleep leads to cognitive and/or somatic arousal that further interferes with sleep and perpetuates the sleep problem.
“This model posits that, with time, conditioned insomnia develops and persists even after the stressor is removed.Specifically, as anxiety about not being able to sleep grows, it can lead to cognitive and/or somatic arousal that further interferes with sleep and perpetuates the sleep problem.13”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [13]
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Study design and conductnone givenThe participants, the psychiatrist managing the medications, and the clinical raters were masked to treatment conditions.
“The participants, the psychiatrist managing the medications, and the clinical raters were masked to treatment conditions.”
Quote in the paperNot a substantial claimMay combine two claims.
InterpretationreasoningInsomnia is no longer simply a symptom of depression, but has become an independent disease process and a comorbid disorder that can subsequently hinder antidepressant response.
“Thus, insomnia is no longer simply a symptom of depression, but has become an independent disease process and a comorbid disorder that can subsequently hinder antidepressant response.”
Quote in the paperSubstantial claimMay combine two claims.
InterpretationreasoningInsomnia is often more than merely a correlate or symptom of depressive illness; it affects the course of the illness, response to treatment, and when unresolved, is a risk factor for relapse.
“Thus, insomnia is often more than merely a correlate or symptom of the depressive illness; it also affects the course of the illness, response to treatment, and when unresolved, it is a risk factor for relapse.”
Quote in the paperSubstantial claimMay combine two claims.
PremisecitationTwo-thirds of patients with persistent insomnia at the end of treatment with nortriptyline and interpersonal psychotherapy relapsed within one year after switching to pill placebo, whereas 90% of patients with good sleep at the end of acute treatment remained well during the first year after discontinuing antidepressants.
“For example, two-thirds of patients with persistent insomnia at the end of treatment with nortriptyline and interpersonal psychotherapy relapsed within one year after switching to pill placebo.In contrast, 90% of patients with good sleep at the end of the acute treatment remained well during the first year after discontinuing antidepressants.11”
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Study design and conductcitationMedication management followed a standardized protocol.
“Medication management followed a standardized protocol 33”
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Study design and conductown dataThe study protocol was approved by the human subjects committee at Stanford University School of Medicine, and all participants provided written consent.
“The study protocol was approved by the human subjects committee at Stanford University School of Medicine, and all participants provided a written consent for participation.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductown dataAdvertising materials did not disclose the study hypothesis.
“The advertisements invited participation in a study on depression and insomnia and did not disclose the study hypothesis.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable).
PremisecitationRemission of depression is the ultimate goal of depression treatment.
“This is a clinically meaningful finding as remission of depression is the ultimate goal of depression treatment.28”
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PremisecitationThe primary endpoint of the fluoxetine and eszopiclone study (n = 545) was time awake after sleep onset rather than remission of depression, but remission of depression was also reported.
“The primary endpoint of this large study (n = 545) was time awake after sleep onset rather than remission of depression, but the latter was also reported.”
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Study design and conductown dataThe possibility that differential expectations of benefit confounded our findings needs to be considered.
“The possibility that differential expectations of benefit confounded our findings needs to be considered.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable).
InterpretationreasoningImproved sleep could have generalized to improvements in mood, concentration, energy, and coping.
“Given that mood, concentration, energy, and coping are often affected by poor sleep, improved sleep could have generalized to improvements in these symptoms.”
Quote in the paperNot a substantial claim- Rests on an assumption: Mood, concentration, energy, and coping are often affected by poor sleep.
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductown dataTherapists were trained in CBTI and CTRL and received supervision.
“The therapists, both naïve to CBTI, were trained in the delivery of CBTI through reviewing the treatment manuals and role-playing.Therapists received supervision initially weekly and later biweekly.Training in CTRL followed the same procedures.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Interpretationown dataThe proposed intervention strategy, should it prove efficacious in larger replication studies, will be relatively simple to implement in the community utilizing licensed mental health providers.
“This indicates that the proposed intervention strategy, should it prove efficacious in larger replication studies, will be relatively simple to implement in the community utilizing licensed mental health providers.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationActigraphy provides an acceptable objective longitudinal measure of sleep continuity in natural settings.
“Actigraphy provides an acceptable objective longitudinal measure of sleep continuity in natural settings.39”
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PremisecitationA quasi-desensitization procedure has been used successfully as a control therapy in a seminal insomnia outcome study.
“The CTRL intervention consisted of a quasi-desensitization procedure that has been used successfully as a control therapy in a seminal insomnia outcome study.37”
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Interpretationown dataThe experience in the pilot study suggests that CBTI is acceptable to patients, as evidenced by the fact that only one participant did not tolerate treatment.
“The experience in the pilot study suggests that CBTI is acceptable to patients, as evidenced by the fact that only one participant did not tolerate treatment.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationRelative to fluoxetine and placebo, the combination of fluoxetine and eszopiclone produced 9% higher rates of remission of depression (33% versus 42%).
“The study found that relative to fluoxetine and placebo the combination of fluoxetine and eszopiclone produced 9% higher rates of remission of depression (33% versus 42%).”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [44]
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductreasoningSeasonal variations in light were unlikely to confound the results as CBTI and CTRL were both administered equally at the different times of the year.
“Seasonal variations in light were unlikely to confound the results as CBTI and CTRL were both administered equally at the different times of the year.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductown dataInter-rater reliability for HRSD interviews was high (intraclass correlation 0.96; median symptom-level 0.85).
“The intraclass correlation based on 22 HRSD interviews was 0.96.When examined symptom-by-symptom, the median intraclass correlation was 0.85.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationThe ISI has good psychometric properties.
“It has good psychometric properties.40”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [40]
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductnone givenThe current study has limitations including a small sample, relative homogeneity of the sample with respect to racial distribution, and exclusion of patients with comorbidity.
“Such studies will need to address several limitations of the current study, including our small sample, the relative homogeneity of the sample with respect to racial distribution, and exclusion of patients with comorbidity.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductreasoningEquivalent credibility for both therapies was not maintained in the present study, possibly because the therapists were more experienced.
“This was not the case in the present study, possibly because our therapists were more experienced.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductown dataIn the EsCIT + CBTI group, 13 of 15 randomized participants were included in analysis (2 did not provide post-randomization data); in the EsCIT + CTRL group, 15 were included in analysis.
“13 included in analysis (2 did not provide data post randomization) 15 included in analysis”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). The quote only partly states this claim.
Study design and conductown dataAll baseline P-values were ≥ 0.4.
“All P-values were ≥ 0.4.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing). May combine two claims.
Study design and conductreasoningAs is inherent in a pilot study, the results can only be viewed as tentative and will need replication in larger samples before conclusions about the efficacy of this treatment strategy can be generalized.
“As is inherent in a pilot study, the results can only be viewed as tentative and will need replication in larger samples before conclusions about the efficacy of this treatment strategy can be generalized.”
Quote in the paperNot a substantial claim
The paper relies on this without support.
Escitalopram is a representative of the most commonly prescribed class of antidepressant medications (SSRIs).
“EsCIT was selected as a representative of the most commonly prescribed class of antidepressant medications, the selective serotonin inhibitors (SSRIs).”
The paper relies on this without support.
Mood, concentration, energy, and coping are often affected by poor sleep.
“Given that mood, concentration, energy, and coping are often affected by poor sleep, improved sleep could have generalized to improvements in these symptoms.”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Addressing insomnia in individuals with concurrent insomnia and depression improves both sleep and depression outcomes.
“There is emerging evidence that addressing insomnia in individuals with concurrent insomnia and depression improves both sleep and depression outcomes.8–10”
From Pilot evaluation of the Sleep Ninja: A smartphone application for adolescent insomnia symptoms (2019) · cites this paper as [9]
The severity of affective experiences is reduced when sleep is improved through intervention.
“There is also evidence that the severity of affective experiences is reduced when sleep is improved through intervention [29–33].”
From A structural equation model of the relationship between insomnia, negative affect, and paranoid thinking (2017) · cites this paper as [30]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Table 1 total mean for periodic limb movements does not add up
MinorThe group means are 0.4 and 0.2 events per hour; their mean is 0.3, not the reported total mean of .03. Weighting by the groups' similar sample sizes cannot account for the discrepancy.
Reported 0.03 · recomputed 0.3
“PLM (events per hour) 0.4 (1.3) 0.2 (0.8) .03(1.0)”
Compliance scale is called five-point but has six response values
MinorThe stated anchors run from 0 through 5, yielding six response values rather than five.
“therapists rated each patient on a 5-point Likert scale as to how much each instruction was followed.”
“The Likert scale was anchored as follows: 0 = poor/no compliance; 1 = marginal; 2 = fair; 3 = good; 4 = very good; 5 = excellent.”
Table 2 lists more CBTI participants than the analyzable sample
MinorThe results state that 13 CBTI participants attended a post-randomization assessment and comprised the analyzable sample, but Table 2 labels its baseline and endpoint CBTI results as n=14.
“The analyzable sample consisted of all randomized participants who attended at least one post randomization assessment visit (13 in EsCIT + CBTI and 15 in EsCIT + CTRL).”
“| | CBTI (n=14) | CTRL (n=14) | Cohen's-d | | |”
Abstract reports a different mean age from Table 1
MinorThe abstract gives participants' mean age as 35±18, whereas Table 1 reports a total mean age of 48.6 (13.3). The abstract's figures instead match the table's age of depression onset.
“30 individuals (61% female, mean age 35±18) with MDD and insomnia.”
“Age (years) 49.5 (13.6) 47.8 (13.4) 48.6 (13.3)Female 54% 67% 61% Hispanic 8% 7% 7% Caucasian non-Hispanic 77% 67% 71% Age of depression onset (years) 37 (16.6)33 (19) 35 (18)”
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- Authors
- Manber, R., Edinger, J. D., Gress, J. L., Pedro-Salcedo, M. G. S., Kuo, T. F., & Kalista, T.
- Affiliations
- Stanford University (US)
- Duke Medical Center (US)
- Corresponding author
- Manber, Rachel
- Venue
- Sleep
- Publisher
- Oxford University Press (OUP)
- Published
- 2008-04
- Volume
- 31
- Issue
- 4
- Pages
- 489-495
- ISSN
- 0161-8105 (ISSN-L)
- 1550-9109
- PMC
- PMC2279754
- OpenAlex
- W1436801937
- Cited by
- 868
- References
- 39
- Citations by year
- 2026: 21 · 2025: 31 · 2024: 26 · 2023: 38 · 2022: 35 · 2021: 70 · 2020: 42 · 2019: 52 · 2018: 48 · 2017: 80 · 2016: 50 · 2015: 78 · 2014: 74 · 2013: 58 · 2012: 48
- FWCI
- 53.08
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- SLEEP (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Jazz Pharmaceuticals
- National Institute of Mental Health (R21MH066131, MH066131)
- Topics
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Social Sciences › Psychology › Clinical Psychology › Psychological Treatments and Assessments
- Keywords
- cognitive behavioral therapy for insomnia, major depressive disorder, insomnia, comorbidities, escitalopram, antidepressant augmentation, depression remission, insomnia severity, sleep quality, actigraphy, sleep diary
- MeSH terms
- Adult, Major Depressive Disorder, Female, Humans, Sleep Initiation and Maintenance Disorders, Male, Pilot Projects, Remission Induction, Citalopram, Comorbidity, Cognitive Behavioral Therapy, Treatment Outcome, Selective Serotonin Reuptake Inhibitors
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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