Cognitive-behavioral Therapy for Treatment of Post-traumatic Stress Disorder and Related Problems

NCT03019497 | Completed

• 1 other identifier: 365935
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of a form of cognitive behavioral therapy (CBT) in a population of individuals with PTSD and common related problems (depression, anxiety or sleep disorders, pain, psychosocial stressors, low social support, substance use disorder). Half of the participants will receive a cognitive behavioral therapy with specific modules for the treatment of related problems (CBT-E) and the other half of participants will receive therapy without specific modules (CBT-C). 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.

Conditions

PTSD

Keywords

PTSD; Related Problems; Therapy; Traumatic Event; Quality of Life; Cognitive Behavioral Therapy (CBT); Major depression; Sleep disorders; Pain; Stressors; Social support; Substance use disorder; Anxiety disorder

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al., 2013)

  The CAPS-5 will be used to evaluate the presence 20 symptoms indicative of PTSD according to the DSM-5. This scale was designed not only to assess symptoms but also to provide indications regarding symptoms onset and duration, associated subjective distress, perceived impact of symptoms on social and professional functioning, changes in symptomology since the previous CAPS assessment and global severity of PTSD.

  Baseline, changes from baseline at 1 week post-treatment, 3 months post-treatment, and 6 months post-treatment

Secondary Outcomes (11)

• The Structured Clinical Interview (SCID-I; First, Spitzer, Gibbon & Williams, 1995)

  Baseline, 1 week post-treatment, 3 months post-treatment, 6 months post-treatment

• The Beck II Depression Inventory (BDI-II; Beck, Steer & Brown, 1996)

  Baseline, 1 week post-treatment, 3 months post-treatment, 6 months post-treatment

• The Beck Anxiety Inventory (BAI; Beck, Epstein, Brown & Steer, 1988)

  Baseline, 1 week post-treatment, 3 months post-treatment, 6 months post-treatment

• The WHOQOL - Bref (WHOQOL Group, 1998)

  Baseline, every 4 weeks during treatment, 1 week post-treatment, 3 months post-treatment, 6 months post-treatment, 1 year post-treatment

• The Inventory of Social Support in Anxious Situations (ISSAS; St-Jean-Trudel et al., 2005)

  Baseline, 1 week post-treatment, 3 months post-treatment, 6 months post-treatment

Study Arms (2)

CBT-E

EXPERIMENTAL

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.

Behavioral: Specific Modules; Behavioral: Cognitive behavioral therapy

CBT-C

ACTIVE COMPARATOR

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.

Behavioral: Cognitive behavioral therapy

Interventions

Specific Modules BEHAVIORAL

Educational session about a specific related problem

CBT-E

Cognitive behavioral therapy BEHAVIORAL

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-E

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Exposed to a traumatic event at an adult age
• 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.

You may not qualify if:

• Schizophrenia diagnostic, current or past psychotic episodes, bipolar disorder, organic cerebral disorder or intellectual deficiency
• 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.

Sponsors & Collaborators

• Université de Montréal: lead
• Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal: collaborator

Study Sites (1)

Stephane Guay

Montreal, Quebec, H1N 3V2, Canada

Location

Related Publications (17)

• 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.

  PMID: 15677582 BACKGROUND

• 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.

  PMID: 7712061 BACKGROUND

• 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.

  PMID: 9626712 BACKGROUND

• 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.

  PMID: 3204199 BACKGROUND

• 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.

  PMID: 23995030 BACKGROUND

• 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.

  PMID: 23106761 BACKGROUND

• 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.

  PMID: 2748771 BACKGROUND

• 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.

  PMID: 6565302 BACKGROUND

• 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.

  PMID: 15986784 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 16505924 BACKGROUND

• 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.

  BACKGROUND

• Cutrona CE, Russell DW. The provisions of social support and adaptation to stress. Advance in Personal Relationship. 1987;(1):37-67.

  BACKGROUND

• 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.

  BACKGROUND

• Beck A, Steer R, Brown G. Manuel de l'inventaire de presentation de Beck (2nd ed.). 1996; Toronto : Harcourt Brace & Company Canada.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 37795783 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depressive Disorder, Major; Sleep Wake Disorders; Pain; Substance-Related Disorders; Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Depressive Disorder; Mood Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Stéphane Guay, PhD

  Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 12, 2017
• Study Start: January 1, 2017
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)