Optimizing Treatment of Complicated Grief: A Randomized Clinical Trial
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IMPORTANCE: To our knowledge, this is the first placebo-controlled randomized clinical trial to evaluate the efficacy of antidepressant pharmacotherapy, with and without complicated grief psychotherapy, in the treatment of complicated grief. OBJECTIVE: To confirm the efficacy of a targeted complicated grief treatment (CGT), determine whether citalopram (CIT) enhances CGT outcome, and examine CIT efficacy without CGT. DESIGN, SETTING, AND PARTICIPANTS: Included in the study were 395 bereaved adults who met criteria for CG recruited from March 2010 to September 2014 from academic medical centers in Boston, Massachusetts; New York, New York; Pittsburgh, Pennsylvania; and San Diego, California. Co-occurring substance abuse, psychosis, mania, and cognitive impairment were exclusionary. Study participants were randomized using site-specific permuted blocks stratified by major depression into groups prescribed CIT (n = 101), placebo (PLA; n = 99), CGT with CIT (n = 99), and CGT with PLA (n = 96). Independent evaluators conducted monthly assessments for 20 weeks. Response rates were compared under the intention-to-treat principle, including all randomized participants in a logistic regression with inverse probability weighting. INTERVENTIONS: All participants received protocolized pharmacotherapy optimized by flexible dosing, psychoeducation, grief monitoring, and encouragement to engage in activities. Half were also randomized to receive manualized CGT in 16 concurrent weekly sessions. MAIN OUTCOMES AND MEASURES: Complicated grief-anchored Clinical Global Impression scale measurments every 4 weeks. Response was measured as a rating of "much improved" or "very much improved." RESULTS: Of the 395 study participants, 308 (78.0%) were female and 325 (82.3%) were white. Participants' response to CGT with PLA vs PLA (82.5% vs 54.8%; relative risk [RR], 1.51; 95% CI, 1.16-1.95; P = .002; number needed to treat [NNT], 3.6) suggested the efficacy of CGT, and the addition of CIT did not significantly improve CGT outcome (CGT with CIT vs CGT with PLA: 83.7% vs 82.5%; RR, 1.01; 95% CI, 0.88-1.17; P = .84; NNT, 84). However, depressive symptoms decreased significantly more when CIT was added to treatment (CGT with CIT vs CGT with PLA: model-based adjusted mean [standard error] difference, -2.06 [1.00]; 95% CI, -4.02 to -0.11; P = .04). By contrast, adding CGT improved CIT outcome (CIT vs CGT with CIT: 69.3% vs 83.7%; RR, 1.21; 95% CI, 1.00-1.46; P = .05; NNT, 6.9). Last, participant response to CIT was not significantly different from PLA at week 12 (45.9% vs 37.9%; RR, 1.21; 95% CI, 0.82-1.81; P = .35; NNT, 12.4) or at week 20 (69.3% vs 54.8%; RR, 1.26; 95% CI, 0.95-1.68; P = .11; NNT, 6.9). Rates of suicidal ideation diminished to a substantially greater extent among participants receiving CGT than among those who did not. CONCLUSIONS AND RELEVANCE: Complicated grief treatment is the treatment of choice for CG, and the addition of CIT optimizes the treatment of co-occurring depressive symptoms. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01179568.
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Grief-focused psychotherapy is more effective than other often-used psychotherapeutic interventions and selective serotonin reuptake inhibitors (SSRIs) for prolonged grief disorder.
“There is also evidence that this treatment is more effective than other often-used psychotherapeutic interventions 125 as well as selective serotonin reuptake inhibitors (SSRIs) 129 .”
From Emerging experience with selected new categories in the <scp>ICD</scp>‐11: complex <scp>PTSD</scp>, prolonged grief disorder, gaming disorder, and compulsive sexual behaviour disorder (2022) · cites this paper as [129]
The Results (Main Outcome Analyses; page not available) report a higher response when complicated grief treatment was added to citalopram than with citalopram alone. The study tested one SSRI, citalopram, and did not report a direct comparison of psychotherapy alone against citalopram alone, so it does not establish the broader claim that psychotherapy is more effective than SSRIs. The separate citation numbered 125, rather than this paper, is attached to the comparison with other psychotherapies. (LLM, conf=0.84)
Experimental — accuracy not yet measuredPsychotherapeutic treatment for complicated grief is more effective for depression than either interpersonal psychotherapy or antidepressant drugs.
“Psychotherapeutic treatment for complicated grief proved more effective for depression than either interpersonal psychotherapy or antidepressant drugs (Shear et al., 2016).”
From Prolonged grief disorder treatment: An approach to COVID-19 grief (2023) · cites this paper as Shear et al., 2016
The Introduction reports that complicated grief treatment produced better outcomes than grief-focused interpersonal psychotherapy, but does not say it was more effective for depression. The Results (Main Outcome Analyses) instead report that adding citalopram to complicated grief treatment significantly reduced depressive symptoms; the paper does not establish the claimed superiority over antidepressants for depression. (LLM, conf=0.87)
Experimental — accuracy not yet measuredComplicated Grief Treatment (CGT) found large, positive effects on PGS.
“Complicated Grief Treatment (CGT; Shear et al., 2005), which also in cludes cognitive treatment components, found large, positive effects of CGT on PGS (Shear et al., 2016; Supiano and Luptak, 2014).”
From Group-based compassion-focused therapy for prolonged grief symptoms in adults – Results from a randomized controlled trial (2022) · cites this paper as Shear et al., 2016
Established CBT and CGT programs for pathological grief consist of ≥12 sessions.
“established CBT (e.g., Boelen et al., 2007; Bryant et al., 2014) and CGT (e.g., Shear et al., 2016) programs for pathological grief consists of ≥ 12 sessions”
From Group-based compassion-focused therapy for prolonged grief symptoms in adults – Results from a randomized controlled trial (2022) · cites this paper as Shear et al., 2016
Prolonged grief treatment was found to be the treatment of choice.
“Prolonged grief treatment was found to be the treatment of choice, while the addition of citalopram proved to improve the therapeutic response in patients with co-occurring depressive symptoms.”
From Prolonged grief disorder treatment: An approach to COVID-19 grief (2023) · cites this paper as Shear et al., 2016
The addition of citalopram improves the therapeutic response in patients with co-occurring depressive symptoms.
“Prolonged grief treatment was found to be the treatment of choice, while the addition of citalopram proved to improve the therapeutic response in patients with co-occurring depressive symptoms.”
From Prolonged grief disorder treatment: An approach to COVID-19 grief (2023) · cites this paper as Shear et al., 2016
Prolonged grief disorder frequently coexists with major depression in older adults and responds well to grief-specific psychotherapy, but not to antidepressant pharmacotherapy or to interpersonal psychotherapy for depression.
“This condition, which frequently coexists with major depression in older adults, responds well to grief‐specific psychotherapy, but not to antidepressant pharmacotherapy or to interpersonal psychotherapy for depression 226 .”
From Mental health care for older adults: recent advances and new directions in clinical practice and research (2022) · cites this paper as [226]
Depression usually precedes mania in bipolar disorder, so that the index presentation of this disorder in youth is often depression.
“Complicating the picture in a young person, depression usually precedes mania in bipolar disorder, so that the index presentation of this disorder in youth is often depression. 96”
From Time for united action on depression: a Lancet–World Psychiatric Association Commission (2022) · cites this paper as [96]
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- Authors
- Shear, M. K., Reynolds, C. F., Simon, N. M., Zisook, S., Wang, Y., Mauro, C., Duan, N., Lebowitz, B., & Skritskaya, N.
- Affiliations
- Columbia University (US)
- University of Pittsburgh (US)
- Harvard University (US)
- University of California San Diego (US)
- Columbia University Irving Medical Center (US)
- Corresponding author
- Shear, M. Katherine
- ORCID
- Venue
- JAMA Psychiatry
- Publisher
- American Medical Association (AMA)
- Published
- 2016-07-01
- Volume
- 73
- Issue
- 7
- Pages
- 685
- ISSN
- 2168-622X (ISSN-L)
- PMC
- PMC5735848
- OpenAlex
- W2412386965
- Cited by
- 349
- References
- 40
- Citations by year
- 2026: 33 · 2025: 33 · 2024: 48 · 2023: 37 · 2022: 30 · 2021: 43 · 2020: 39 · 2019: 26 · 2018: 25 · 2017: 29 · 2016: 5
- FWCI
- 37.93
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Funders
- American Foundation for Suicide Prevention
- National Institutes of Health (UL1TR000005)
- National Institute of Mental Health (R01MH085297, P30MH090333, R01MH085308, R01MH060783, R01MH085288)
- National Center for Research Resources (UL1RR024153)
- National Center for Advancing Translational Sciences
- National Institute on Minority Health and Health Disparities (P60MD000207)
- Topics
- Social Sciences › Psychology › Clinical Psychology › Grief, Bereavement, and Mental Health
- Social Sciences › Anthropology › Death, Funerary Practices, and Mourning
- Social Sciences › Psychology › Clinical Psychology › Posttraumatic Stress Disorder Research
- Keywords
- complicated grief, citalopram, antidepressant treatment, bereavement, psychotherapy, treatment response, major depressive disorder, flexible dosing, psychoeducation, activities of daily living, Clinical Global Impression Scale, number needed to treat, intention-to-treat analysis, inverse probability weighting
- MeSH terms
- Adjustment Disorders, Adult, Aged, Combined Modality Therapy, Depressive Disorder, Double-Blind Method, Female, Grief, Humans, Male, Middle Aged, Psychotherapy, Citalopram, Comorbidity, Treatment Outcome
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