Controlled trial of psychotherapy for Congolese survivors of sexual violence

Probably not a substantial claim: may not pass S3 (load-bearing).

Ongoing supervision was provided through a multitiered supervision system.

“Ongoing supervision was provided through a multitiered supervision system that was first used in Uganda 31 and subsequently expanded.32”

• cites [31] 31. Verdeli H, Clougherty K, Bolton P, et al. Adapting group interpersonal psycho- therapy for a developing country: experi- ence in rural Uganda. World Psychiatry 2003;2:114-20.Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [32] 32. Murray LK, Dorsey S, Bolton P, et al. Building capacity in mental health inter- ventions in low resource countries: an apprenticeship model for training local providers. Int J Ment Health Syst 2011; 5:30. sourceSupported

May combine two claims.

Cognitive processing therapy has shown efficacy in high-income countries, with effects lasting for 5 or more years.

“Cognitive processing therapy has shown efficacy in high-income countries, with effects lasting for 5 or more years.[13][14][15]”

• cites [13] 13. Chard KM. An evaluation of cognitive processing therapy for the treatment of posttraumatic stress disorder related to childhood sexual abuse. J Consult Clin Psychol 2005;73:965-71.Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [14] 14. Resick PA, Nishith P, Weaver TL, As- tin MC, Feuer CA. A comparison of cogni- tive-processing therapy with prolonged exposure and a waiting condition for the treatment of chronic posttraumatic stress disorder in female rape victims. J Consult Clin Psychol 2002;70:867-79.Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [15] 15. Resick PA, Williams LF, Suvak MK, Monson CM, Gradus JL. Long-term out- comes of cognitive-behavioral treatments for posttraumatic stress disorder among female rape survivors. J Consult Clin Psy- chol 2012;80:201-10. sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

Prior studies have shown that increases in the quality and quantity of clinical supervision can explain some treatment effects.

“Prior studies have shown that increases in the quality and quantity of clinical supervision can explain some treatment effects.39,40”

• cites [39] 39. Sholomskas DE, Syracuse-Siewert G, Rounsaville BJ, Ball SA, Nuro KF, Carroll KM. We don't train in vain: a dissemina- tion trial of three strategies of training clinicians in cognitive-behavioral therapy. J Consult Clin Psychol 2005;73:106-15. sourceNot checked — no full text of the source
• cites [40] 40. Stewart RE, Chambless DL. Cogni- tive-behavioral therapy for adult anxiety disorders in clinical practice: a meta- analysis of effectiveness studies. J Consult Clin Psychol 2009;77:595-606. sourcePartly supported

  The Results (page unavailable) associate lack of therapist training and treatment monitoring with smaller outcome effect sizes. The Discussion (page unavailable) cautions that these analyses are exploratory and correlational. The paper does not assess increases in the quality or quantity of clinical supervision specifically, or establish that supervision explains treatment effects. (LLM, conf=0.84)

  Experimental — accuracy not yet measured

May combine two claims.

Both the individual-support and therapy groups had significant improvements during treatment, with effects maintained at 6 months.

“Both the individual-support and therapy groups had significant improvements during treatment, with effects maintained at 6 months (Fig. 2).”

May combine two claims.

Approximately 70% of participants in the therapy group met criteria for probable depression or anxiety at baseline, with 10% or less meeting the criteria at either follow-up assessment.

“Approximately 70% of participants in the therapy group met our criteria for probable depression or anxiety at baseline, with 10% or less meeting the criteria at either follow-up assessment (Table 2).”

May combine two claims.

For PTSD symptoms (HTQ) and combined depression and anxiety symptoms (HSCL-25), participants in the therapy group had significantly greater improvements than those in the individual-support group at both follow-up assessments, with all treatment-effect sizes greater than 1.0.

“For PTSD symptoms (HTQ) and combined depression and anxiety symptoms (HSCL-25), participants in the therapy group had significantly greater improvements than those in the individual-support group (Table 2) at both follow-up as-sessments, with all treatment-effect sizes greater than 1.0.”

May combine two claims.

The symptom scores of participants in the therapy group decreased, on average, to less than a little bit (a score of 1), whereas the scores of participants in the individual-support group remained closer to a moderate amount.

“The symptom scores of participants in the therapy group decreased, on average, to less than”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

All comparisons were prespecified, and all tests were two-sided.

“All comparisons were prespecified, and all tests were two-sided.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Psychosocial assistants who provided therapy underwent 2 weeks of in-person training.

“Psychosocial assistants who provided therapy underwent 2 weeks of in-person training with trainers based in the United States (the fourth and fifth authors), with the use of a manual 30 that was adapted and translated locally.”

May combine two claims.

The benefits of therapy were large and were maintained 6 months after treatment ended.

“efits were large and were maintained 6 months after treatment ended.”

May combine two claims.

A total of 65% of participants in the therapy group and 52% in the individual-support group completed all three assessments.

“A total of 65% of participants in the therapy group and 52% of participants in the individual-support group completed all three assessments.”

May combine two claims.

The HSCL-25 and HTQ have been used internationally with sexual-violence survivors and have solid psychometric properties with conflict-affected samples.

“Both the HSCL-25 and the HTQ have been used internationally with sexualviolence survivors 20 and have solid psychometric properties with conflict-affected samples [21][22][23]”

• cites [20] 20. Tsutsumi A, Izutsu T, Poudyal AK, Kato S, Marui E. Mental health of female survivors of human trafficking in Nepal. Soc Sci Med 2008;66:1841-7. sourceNot checked — no full text of the source
• cites [21] 21. Conybeare D, Behar E, Solomon A, Newman MG, Borkovec TD. The PTSD Checklist -Civilian Version: reliability, validity, and factor structure in a nonclin- ical sample. J Clin Psychol 2012;68:699- 713. sourceNot checked — no full text of the source
• cites [22] 22. Ruggiero KJ, Del Ben K, Scotti JR, Ra- balais AE. Psychometric properties of the PTSD Checklist -Civilian Version. J Trauma Stress 2003;16:495-502. sourceNot checked — no full text of the source

May combine two claims.

The findings suggest that despite illiteracy and ongoing conflict, this evidence-based treatment can be appropriately implemented and effective.

“Our findings suggest that despite illiteracy and ongoing conflict, this evidence-based treatment can be appropriately implemented and effective.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Problems with security and cases in which the wrong women were interviewed reduced the number of follow-up assessments.

“Problems with security and cases in which the wrong women were interviewed reduced the number of follow-up assessments.”

Classified as probably not a substantial claim.

Analyses were performed on data from all participants, regardless of level of participation.

“Analyses were performed on data from all participants, regardless of the level of participation.”

Classified as probably not a substantial claim.

Differences in how therapy and individual support were provided may affect the conclusions.

“Finally, differences in how therapy and individual support were provided may affect our conclusions.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Compared with participants in the therapy group, those in the individual-support group were younger, less likely to be married, and lived with fewer people.

“As compared with participants in the therapy group, those in the individual-support group were younger and less likely to be married, and they lived with fewer people (Table 1).”

May combine two claims.

Factors significantly associated with loss to follow-up were older age, assignment to individual support, pregnancy at baseline, experience with or witnessing of a wider range of traumas, and language spoken.

“Factors that were significantly associated with loss to follow-up were older age (with age as a continuous variable), assignment to individual support, pregnancy at baseline, experience with or witnessing of a wider range of traumas, and language spoken.”

Classified as probably not a substantial claim.

Prior research has suggested that short-term therapies may not be effective for populations exposed to ongoing trauma or multiple severe traumas.

“Prior research has suggested that short-term therapies may not be effective for populations exposed to ongoing trauma or multiple severe traumas.37,38”

• cites [37] 37. Cloitre M, Stovall-McClough KC, Nooner K, et al. Treatment for PTSD re- lated to childhood abuse: a randomized controlled trial. Am J Psychiatry 2010; 167:915-24. sourceNot checked — no full text of the source
• cites [38] 38. Dorrepaal E, Thomaes K, Smit JH, et al. Stabilizing group treatment for com- plex posttraumatic stress disorder relat- ed to childhood abuse based on psycho- education and cognitive behavioral therapy: a pilot study. Child Abuse Negl 2010;34:284-8. sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Although the clinical meaning of standard cutoff scores is uncertain, the score itself can still be meaningfully interpreted: 1.75 indicates that women are reporting that symptoms occur, on average, nearly a moderate amount of the time (a score of 2.0).

“Although the clinical meaning of standard cutoff scores is therefore uncertain, the score itself can still be meaningfully interpreted: 1.75 indicates that women are reporting that symptoms occur, on average, nearly a”

Probably not a substantial claim: may not pass S3 (load-bearing).

Randomization was performed within blocks of two to four villages grouped on the basis of language and proximity.

“Randomization was performed within blocks of two to four villages grouped on the basis of language and proximity”

• AssumptionThe authors state this as an assumption: Villages close to one another would be similar.

Probably not a substantial claim: may not pass S3 (load-bearing).

IRC supervisors monitored the services provided by means of monthly visits and reviews of interim monitoring forms.

“IRC supervisors monitored the services provided by means of monthly visits and reviews of interim monitoring forms.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Fidelity to the therapy protocol was assessed with checklists of key treatment elements and global ratings.

“Fidelity to the therapy protocol was assessed with the use of checklists of key treatment elements and global ratings of treatment knowledge and skills, as observed by supervisors during group sessions.”

May combine two claims.

The results indicate that with appropriate training and supervision, psychotherapeutic treatments such as cognitive processing therapy can be successfully implemented and can have an effect in settings with few mental health professionals.

“The results indicate that with appropriate training and supervision, psychotherapeutic treatments such as cognitive processing therapy can be successfully implemented and can have an effect in settings with few mental health professionals.”

Classified as probably not a substantial claim. May combine two claims.

Eastern Democratic Republic of Congo is a low-income, conflict-affected region with ongoing political and economic instability.

“Eastern Democratic Republic of Congo is a low-income, conflict-affected region in which political and economic instability are ongoing problems and nearly 40% of women have experienced sexual violence.12”

• cites [12] 12. Johnson K, Scott J, Rughita B, et al. Association of sexual violence and human rights violations with physical and mental health in territories of the Eastern Demo- cratic Republic of the Congo. JAMA 2010;304:553-62. sourceNot checked — no full text of the source

Classified as probably not a substantial claim. May combine two claims.

Measures were adapted, pilot-tested, and translated into local languages.

“The checklists were adapted and pilot-tested in each language group.”

• Also stated in: § Setting, Participants, and Assessment Measures · plain

  “Study measures were translated into five local languages: Kibembe, Kifuliro, Kihavu, Mashi, and Swahili.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The sponsors had no role in trial design, conduct, data analysis, or manuscript preparation.

“The sponsors had no role in the trial design or conduct; the collection, management, analysis, or interpretation of data; or manuscript preparation, review, or approval.”

Probably not a substantial claim: may not pass S3 (load-bearing).

There may have been biases in recruitment that resulted in higher average symptom scores in villages that provided individual support because psychosocial assistants recruiting patients knew ahead of time whether they would be providing therapy or individual support.

“There may also have been biases in recruitment that resulted in higher average symptom scores in villages that provided individual support because psychosocial assistants recruiting patients knew ahead of time whether they would be providing therapy or individual support.”

May combine two claims.

An average HSCL-25 score of 1.75 or higher and an average HTQ score of 1.75 or higher are predictive of clinically significant depression or anxiety and PTSD, respectively, in conflict-affected populations.

“An average HSCL-25 score of 1.75 or higher and an average HTQ score of 1.75 or higher were considered to be predictive of clinically significant depression or anxiety and PTSD, respectively, on the basis of data from other conflict-affected populations.24,25”

• cites [24] 24. Mollica RF, Wyshak G, de Marneffe D, Khuon F, Lavelle J. Indochinese versions of the Hopkins Symptom Checklist-25: a screening instrument for the psychiatric care of refugees. Am J Psychiatry 1987; 144:497-500. sourceNot checked — no full text of the source
• cites [25] 25. McDonald SD, Calhoun PS. The diag- nostic accuracy of the PTSD Checklist: a critical review. Clin Psychol Rev 2010;30: 976-87. sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

Because therapy, but not individual support, was provided in groups, it is unclear how much of the treatment effect was due to the group context.

“Because therapy, but not individual support, was provided in groups, it is unclear how much of the treatment effect was due to the group context.”

May combine two claims.

In this study, cognitive processing therapy, as compared with individual support alone, was effective in reducing PTSD symptoms and combined depression and anxiety symptoms and improving functioning in female survivors of sexual violence in eastern Democratic Republic of Congo.

“In our study, cognitive processing therapy, as compared with individual support alone, was effective in reducing PTSD symptoms and combined depression and anxiety symptoms and improving functioning in female survivors of sexual violence in eastern Democratic Republic of Congo.”

• AssumptionThe authors state this as an assumption: Villages close to one another would be similar.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Because symptoms of these disorders could be nonpathologic reactions to extreme circumstances, it is unclear what proportions of participants actually met clinical criteria.

“Because symptoms of these disorders could be nonpathologic reactions to extreme circumstances, it is unclear what proportions of participants actually met clinical criteria.”

May combine two claims.

Participants in the therapy group attended an average of 8.5 of 12 sessions, with 141 (90%) completing at least 9 sessions.

“Participants in the therapy group attended an average of 8.5 of 12 sessions offered, with 141 participants (90%) completing at least 9 sessions (defined as treatment completion).”

Classified as probably not a substantial claim.

Assuming a 20% dropout rate, enrollment of 180 participants per group would provide 80% power to detect at least a 0.5-point difference between groups in reduction in average symptom scores, adjusting for a variance-inflation factor of 2.0.

“Assuming a 20% dropout rate, we calculated that enrollment of 180 participants in each study group would provide 80% power to detect at least a 0.5-point difference between groups with respect to the reduction in average symptom scores, adjusting for a variance-inflation factor of 2.0.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The therapy was adapted for illiterate participants and those potentially exposed to ongoing violence.

“The therapy was adapted for illiterate participants and those potentially exposed to ongoing violence.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Institutional review boards approved the protocol.

“Institutional review boards at the Johns Hopkins Bloomberg School of Public Health and Kinshasa School of Public Health approved the protocol.”

May combine two claims.

In this study of sexual-violence survivors in a low-income, conflict-affected country, group psychotherapy reduced PTSD symptoms and combined depression and anxiety symptoms and improved functioning.

“In this study of sexual-violence survivors in a low-income, conflict-affected country, group psychotherapy reduced PTSD symptoms and combined depression and anxiety symptoms and improved functioning.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

An additional 4 women who did not meet the inclusion criterion of a total symptom score of at least 55 were mistakenly recruited in one therapy village; these women were included in the analysis.

“An additional 4 women who did not meet the inclusion criterion of a total symptom score of at least 55 were mistakenly recruited in one village that provided therapy; these women were included in the analysis.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

One village was excluded because of concerns about the psychosocial assistant's competency, leaving 15 villages (7 therapy, 8 individual support).

“After therapy training, one psychosocial assistant was excluded because training-based quizzes and skill observation raised competency concerns; therefore, the village in which she worked was excluded.The trial included 15 study villages (7 that provided therapy and 8 that provided individual support).”

Classified as probably not a substantial claim.

Factors associated with loss to follow-up were used to generate weighting estimates to adjust for loss to follow-up.

“Factors associated with loss to follow-up were identified with the use of lo-gistic regression; those at a significance level of less than 0.20 were used to generate weighting estimates to adjust for loss to follow-up (data were missing for 135 participants [33%] at the end of treatment and for 92 participants [23%] at 6 months after treatment).”

May combine two claims.

A total of 231 women (57%) completed all three assessments; 352 (87%) completed baseline and at least one follow-up.

“A total of 231 women (57%) completed all three assessments; 352 (87%) completed the baseline assessment and at least one follow-up assessment.”

Classified as probably not a substantial claim.

Cognitive processing therapy is a protocol-based therapy for treating depression, anxiety, and PTSD in sexual-violence survivors.

“Cognitive processing therapy is a protocol-based therapy for treating depression, anxiety, and PTSD in sexual-violence survivors.9,[27][28][29]”

• cites [9] 9. Ougrin D. Efficacy of exposure versus cognitive therapy in anxiety disorders: systematic review and meta-analysis. BMC Psychiatry 2011;11:200.Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [27] 27. Resick PA, Schnicke MK. Cognitive pro- cessing therapy for sexual assault victims. J Consult Clin Psychol 1992;60:748-56.Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [28] 28. Resick PA, Galovski TE, O'Brien Uhl- mansiek M, Scher CD, Clum GA, Young-Xu Y. A randomized clinical trial to dismantle components of cognitive processing thera- py for posttraumatic stress disorder in female victims of interpersonal violence. J Consult Clin Psychol 2008;76:243-58. sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

After exclusion of 1 participant who received therapy owing to paperwork errors, the study included 405 women.

“After the exclusion of 1 participant who received therapy owing to paperwork errors, the study included 405 women.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Functional impairment assessment was based on qualitative data from the study villages.

“Functional impairment was based on the degree of difficulty in performing important tasks of daily living that were identified on the basis of qualitative data from the study villages, with the use of methods described elsewhere.16,26”

• cites [16] 16. Bass JK, Ryder RW, Lammers MC, Mukaba TN, Bolton PA. Post-partum de- pression in Kinshasa, Democratic Repub- lic of Congo: validation of a concept using a mixed-methods cross-cultural approach. Trop Med Int Health 2008;13:1534-42. sourceNot checked — no full text of the source
• cites [26] 26. Bolton P, Tang AM. An alternative ap- proach to cross-cultural function assess- ment. Soc Psychiatry Psychiatr Epidemiol 2002;37:537-43. sourceNot checked — no full text of the source

May combine two claims.

The findings are consistent with results of trials conducted in high-income countries, both for cognitive behavioral interventions in general and for cognitive processing therapy specifically, with effect sizes of 0.62 and 2.7 in the latter two studies.

“Our findings are consistent with the results of trials conducted in high-income countries, both for cognitive behavioral interventions in general 36 and for cognitive processing therapy”

• Also stated in: § Discussion · plain

  “specifically, 14,27 with effect sizes of 0.62 and 2.7 in the latter two studies.”

• cites [36] 36. Olatunji BO, Cisler JM, Deacon BJ. Ef- ficacy of cognitive behavioral therapy for anxiety disorders: a review of meta-ana- lytic findings. Psychiatr Clin North Am 2010;33:557-77. sourceNot checked — no full text of the source
• cites [14] 14. Resick PA, Nishith P, Weaver TL, As- tin MC, Feuer CA. A comparison of cogni- tive-processing therapy with prolonged exposure and a waiting condition for the treatment of chronic posttraumatic stress disorder in female rape victims. J Consult Clin Psychol 2002;70:867-79.Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [27] 27. Resick PA, Schnicke MK. Cognitive pro- cessing therapy for sexual assault victims. J Consult Clin Psychol 1992;60:748-56.Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Study participants provided oral informed consent, and none received compensation.

“Study participants provided oral informed consent, and none received compensation.”

Classified as probably not a substantial claim.

Research assistants who administered assessments were unaware of village treatment assignments.

“research assistants, who were unaware of the village treatment assignments, obtained informed consent and administered the study questionnaires.”

• Also stated in: § Study Design · plain

  “For both follow-up assessments, two research assistants, who were unaware of the village treatment assignments, spent 1 week in each village assessing the study participants.”