Cognitive-behavioral Therapy for Treatment of Post-traumatic Stress Disorder and Related Problems
NCT ID: NCT03019497
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
92 participants
INTERVENTIONAL
2017-01-31
2021-06-30
Brief Summary
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The main assumption is that participants treated in the CBT-E condition will present a lower level of symptom intensity of PTSD and a higher remission rate than those in the CBT-C condition during the post-treatment assessment. As a secondary objective, an analysis of the different parameters of effectiveness of the two forms of CBT (e.g., average number of sessions required to reach remission, treatment strategies used) will be performed.
Detailed Description
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A randomized parallel-stratified single-blind controlled trial will be used. Randomization will be performed through www.randomized.net, a comprehensive internet-based randomization service for clinical trials, with multiple Coordinating Center users (each with their own role). A total of 134 individuals will be randomized to one of two therapy conditions. Following the initial assessment, between 8 and 32 sessions with a psychologist will be offered to participants upon achievement of remission of the diagnosis of PTSD. Discontinuation of treatment will be decided in collaboration with the participant and will be considered on the basis of achieving a non-clinical severity level of symptoms of PTSD on the PCL-5 (i.e., score \<33 and absence or non-clinical level of severity of each of the symptoms). The participants will be re-evaluated 3 times after their therapy (1 week, 3 months and 6 months post-therapy) on primary and secondary measures. A 1 year post-therapy follow-up will also be provided for the primary measure only.
Planned analysis. The statistical analysis will respect the "intent-to-treat" principle: the results of all randomized participants will be included in the groups in which they were originally assigned. The significance level is fixed at .05 and bilateral tests will be used. With regards to missing data, first the type of missing data will be determined (e.g. missing completely randomly). Thereafter, a multiple imputation strategy (3 to 5 imputations) will be used to replace the data and carry out the various analysis planned. This data replacement strategy is recognized as being robust and efficient in addition to resolving uncertainty due to missing data. Generalized linear models will be used to execute group comparisons (CBT-C vs CBT-E) on the main measurements using the pre-treatment (T0) result as a covariate. The same strategy will be used for comparisons of the secondary variables and related problems. An analysis of the different parameters of effectiveness of the two forms of CBT (e.g. average number of sessions required to achieve remission, treatment strategy used) will be carried out.
Subgroup analysis. No subgroup analysis is expected. Exploratory analysis will be conducted to determine if the results are generalizable to victims of both sexes and to the two major categories of traumatic exposures characterizing the sample recruited, namely violent criminal acts and workplace accidents.
Sample size and calculations of treatment effects. Based on the treatment effect size observed in a pilot study on the effects of CBT-E, similar research, and on the use of the GPower power calculation software, the sample size required to obtain statistical power of .80 with 3 follow-ups, a significance level at .05 and bilateral testing for ANCOVA is 53 participants per group. A sample of 106 participants will allow for detections of differences in means between the two groups in terms of symptoms intensity of PTSD. It will also be adequate to verify the other assumptions and objectives of this project. Based on data from our recent studies on the efficacy of CBT-C, and the literature on similar therapies (Bradley et al., 2005), the attrition rate is estimated to be 28% for participants who will be randomized in CBT-C. For CBT-E, the attrition rate observed during a pilot project was 14% (3 dropouts out of 21 participants). Given these attrition rates, recruitment for each of the therapies to achieve the required statistical power is calculated as follows: CBT-C = 53 participants \* attrition (28%) = 74; CBT-E = 53 participants \* attrition (14%) = 60). Consequently, a total of 134 participants will be randomized to one of the two conditions of therapy.
Selection bias: The assignment to the intervention will be made only after the participant has agreed to participate in the study. Bias in statistical analysis: In order to minimize biases, the analysis will be carried out in a single-blind manner, the statistician will not know which intervention refers to the code assigned to each of them in the database. Bias resulting from missing data and dropouts: All analysis will follow the "intent to treat" principle, in order to minimize biases stemming from missing data and drop-outs during the intervention.
Conducting a clinical trial on comparing the effectiveness of CBT with or without specific modules for patients with PTSD and related problems will increase the efficacy of CBT, innovate in the delivery of CBT, and improve the training of current and future clinicians. The results could also encourage victims' compensation boards to adjust their practices and thus improve the health of the beneficiaries.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CBT-E
CBT-E refers to Cognitive Behavioral Therapy with specific modules. In the CBT-E condition and following the identification of the needs identified during the evaluation, additional strategies will be added to the CBT strategies for PTSD to address one or more of the seven related problem types that emerged as a result of the traumatic event: 1) major depression, 2) sleep disorders, 3) pain, 4) stressors, 5) inadequate social support, 6) substance use disorder, and 7) anxiety disorder.
Specific Modules
Educational session about a specific related problem
Cognitive behavioral therapy
PTSD of participants in both conditions will be addressed with cognitive-behavioral intervention strategies. These strategies are: (a) psychoeducation on PTSD, (b) anxiety management training, (c) restructuring irrational thoughts, (d) imaginative and / or in vivo exposure to memories and situations avoided, and (e) strategies for the prevention of relapse.
CBT-C
CBT-C refers to Cognitive Behavioral Therapy without specific modules. CBT-C participants will be offered only cognitive-behavioral intervention strategies to alleviate the symptoms of each of the PTSD diagnostic criteria.
Cognitive behavioral therapy
PTSD of participants in both conditions will be addressed with cognitive-behavioral intervention strategies. These strategies are: (a) psychoeducation on PTSD, (b) anxiety management training, (c) restructuring irrational thoughts, (d) imaginative and / or in vivo exposure to memories and situations avoided, and (e) strategies for the prevention of relapse.
Interventions
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Specific Modules
Educational session about a specific related problem
Cognitive behavioral therapy
PTSD of participants in both conditions will be addressed with cognitive-behavioral intervention strategies. These strategies are: (a) psychoeducation on PTSD, (b) anxiety management training, (c) restructuring irrational thoughts, (d) imaginative and / or in vivo exposure to memories and situations avoided, and (e) strategies for the prevention of relapse.
Eligibility Criteria
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Inclusion Criteria
* Primary PTSD diagnosis according to the DSM-5 criteria
* At least one PTSD related problem (depressive, anxiety or sleep disorders, pain, psychosocial stressors, inadequate social support, substance use disorder)
* Being fluent in French.
Exclusion Criteria
* Presence of a trouble linked to a substance developed prior to the traumatic event
* Physical condition preventing participation in the study (e.g. cerebral trauma)
* Presence of active suicide ideas.
18 Years
70 Years
ALL
No
Sponsors
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Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
OTHER
Université de Montréal
OTHER
Responsible Party
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Stephane Guay
Professor
Principal Investigators
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Stéphane Guay, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Locations
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Stephane Guay
Montreal, Quebec, Canada
Countries
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References
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Bradley R, Greene J, Russ E, Dutra L, Westen D. A multidimensional meta-analysis of psychotherapy for PTSD. Am J Psychiatry. 2005 Feb;162(2):214-27. doi: 10.1176/appi.ajp.162.2.214.
Blake DD, Weathers FW, Nagy LM, Kaloupek DG, Gusman FD, Charney DS, Keane TM. The development of a Clinician-Administered PTSD Scale. J Trauma Stress. 1995 Jan;8(1):75-90. doi: 10.1007/BF02105408.
Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.
Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
Poirier-Bisson J, Marchand A, Pelland ME, Lessard MJ, Dupuis G, Fleet R, Roberge P. Incremental cost-effectiveness of pharmacotherapy and two brief cognitive-behavioral therapies compared with usual care for panic disorder and noncardiac chest pain. J Nerv Ment Dis. 2013 Sep;201(9):753-9. doi: 10.1097/NMD.0b013e3182a2127d.
Galovski TE, Blain LM, Mott JM, Elwood L, Houle T. Manualized therapy for PTSD: flexing the structure of cognitive processing therapy. J Consult Clin Psychol. 2012 Dec;80(6):968-81. doi: 10.1037/a0030600. Epub 2012 Oct 29.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
Norbeck JS. Modification of life event questionnaires for use with female respondents. Res Nurs Health. 1984 Mar;7(1):61-71. doi: 10.1002/nur.4770070110.
Roberge P, Marchand A, Reinharz D, Cloutier K, Mainguy N, Miller JM, Begin J, Turcotte J. Healthcare utilization following cognitive-behavioral treatment for panic disorder with agoraphobia. Cogn Behav Ther. 2005;34(2):79-88. doi: 10.1080/16506070510008443.
Roberge P, Marchand A, Reinharz D, Marchand L, Cloutier K. Évaluation économique de la thérapie cognitive-comportementale des troubles anxieux. Canadian Psychology. 2004 Aug;45(3):202-216.
St-Jean-Trudel E, Guay S, Marchand A, O'Connor K. [Elaboration and validation of a questionnaire measuring social support in situations of anxiety with a population of university students]. Sante Ment Que. 2005 Autumn;30(2):43-60. doi: 10.7202/012138ar. French.
Cleeland CS. (1989). Measurement of pain by subjective report. In CR Chapman and JD Loeser (eds.), Issues in pain measurement, Advances in pain research and therapy (vol. 12, p. 391-403). New York : Raven Press.
Cutrona CE, Russell DW. The provisions of social support and adaptation to stress. Advance in Personal Relationship. 1987;(1):37-67.
Weathers FW, Litz BT, Keane, TM, Palmieri PA, Marx BP, Schnurr, PP. The PTSD Checklist for DSM5 (PCL5). 2003; Retrieved from URL www.ptsd.va.gov.
Beck A, Steer R, Brown G. Manuel de l'inventaire de presentation de Beck (2nd ed.). 1996; Toronto : Harcourt Brace & Company Canada.
First MB, Williams JBW, Karg RS, Spitzer RL. User's Guide for the Structured Clinical Interview for DSM-5 Disorders, Research Version (SCID-5-RV). 2015; Arlington, VA : American Psychiatric Association.
O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.
Other Identifiers
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365935
Identifier Type: -
Identifier Source: org_study_id