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Cognitive-behavioral Therapy for Treatment of Post-traumatic Stress Disorder and Related Problems (CBT-PTSD-RP)

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ClinicalTrials.gov Identifier: NCT03019497
Recruitment Status : Not yet recruiting
First Posted : January 12, 2017
Last Update Posted : January 13, 2017
Sponsor:
Collaborator:
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Information provided by (Responsible Party):
Stephane Guay, Université de Montréal

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.


Condition or disease Intervention/treatment Phase
PTSD Behavioral: Specific Modules Behavioral: Cognitive behavioral therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Towards Optimization of Traumatic Cognitive-behavioral Therapy for Treatment of Post-traumatic Stress Disorder and Related Problems
Study Start Date : January 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Specific Modules
Educational session about a specific related problem

Behavioral: 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.

Active Comparator: 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.
Behavioral: 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.




Primary Outcome Measures :
  1. Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al., 2013) [ Time Frame: Baseline, changes from baseline at 1 week post-treatment, 3 months post-treatment, and 6 months post-treatment ]
    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.


Secondary Outcome Measures :
  1. The Structured Clinical Interview (SCID-I; First, Spitzer, Gibbon & Williams, 1995) [ Time Frame: Baseline, 1 week post-treatment, 3 months post-treatment, 6 months post-treatment ]
    SCID-I will be used to evaluate the presence of Axis-1 disorders other than acute stress disorder according to the DSM-5.

  2. The Beck II Depression Inventory (BDI-II; Beck, Steer & Brown, 1996) [ Time Frame: Baseline, 1 week post-treatment, 3 months post-treatment, 6 months post-treatment ]
    BDI-II consists of 21 items intended to assess the presence and severity of depressive symptoms in the last two weeks.

  3. The Beck Anxiety Inventory (BAI; Beck, Epstein, Brown & Steer, 1988) [ Time Frame: Baseline, 1 week post-treatment, 3 months post-treatment, 6 months post-treatment ]
    BAI is a self-reported 21-item instrument assessing the main symptoms experienced by clinically anxious individuals as defined by the DSM-IV. Participants rate the intensity of symptoms experienced over the past week on a scale ranging from 0 (Not al all) to 3 (A lot).

  4. The WHOQOL - Bref (WHOQOL Group, 1998) [ Time Frame: Baseline, every 4 weeks during treatment, 1 week post-treatment, 3 months post-treatment, 6 months post-treatment, 1 year post-treatment ]
    WHOQOL is a 26 items self-reported measure that will be used to evaluate the quality of life in four key spheres of life: physical health, quality of the environment, mental health and social relations.

  5. The Inventory of Social Support in Anxious Situations (ISSAS; St-Jean-Trudel et al., 2005) [ Time Frame: Baseline, 1 week post-treatment, 3 months post-treatment, 6 months post-treatment ]
    ISSAS will be used to evaluate the frequency of different types of supporting behaviors and the perception thereof in anxiety-provoking situations.The questionnaire contains 31 items divided in two dimensions, negative and positive social support.

  6. The Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, 1 week post-treatment, 3 months post-treatment, 6 months post-treatment ]
    PSQI is a self-report questionnaire containing 19 items evaluating seven components of sleep quality: (a) subjective quality of sleep; (b) sleep latency; (c) sleep duration; (d) sleep efficiency; (e) sleep perturbation; (f) intake of hypnotic medications and (g) impact on daily activities. A scale ranging from 0 to 3 is used to measure each component; the sum of which provides researchers with a global indication of sleep quality on a scale ranging from 0 to 21. An addendum of seven additional items targeting sleep difficulties specific to individuals suffering from PTSD will also be used and has been previously validated (Germain, Hall, Krakow, Shear, & Buysse, 2005).

  7. The Life Events Questionnaire (LEQ; Norbeck, 1984) [ Time Frame: Baseline, 1 week post-treatment, 3 months post-treatment, 6 months post-treatment ]
    LEQ is an 82-item self-report questionnaire that will be used to evaluate the presence of potentially stressful life events over a determined period. The instrument has 9 dimensions (e.g. parenthood, justice) and participants must determine if the event had a positive or negative impact on their life before quantifying the severity of this impact (none, low, average, important).

  8. The Brief Pain Inventory (BPI; Cleeland, 1989) [ Time Frame: Baseline, 1 week post-treatment, 3 months post-treatment, 6 months post-treatment ]
    BPI will be used to evaluate the pain severity and its interference. The sub-scale assessing pain severity has 4 items, each using a Likert scale ranging from 0 (no pain) to 10 (the worst pain you can imagine). The second sub-scale, evaluating pain interference, contains 7 items, each using Likert scale ranging from 0 (no interference) to 10 (interferes severely).

  9. The Health Cost Interview [ Time Frame: Baseline, 3 months post-treatment ]
    The Health Cost Interview is a semi-structured interview comprising of 19 items. It has been used previously by other researchers (Roberge, Marchand, Reinharz, Marchand, & Cloutier, 2004; Roberge et al., 2005; Poirier-Bisson et al., 2013) to determine the costs associated with healthcare service use as well as costs attributed to absenteeism and work-related sick leaves since the traumatic event. The interview includes items on the consultations with medical professionals, both generalists and specialists, as well as with allied health professionals (e.g. psychologist, social worker). It also assesses the medication intake and work absenteeism.

  10. The Social Provisions Scale (SPS; Cutrona & Russel, 1987) [ Time Frame: Baseline, 1 week post-treatment, 3 months post-treatment, 6 months post-treatment ]
    SPS will be used to evaluate the perceptions regarding social support in general. This 24-item questionnaire measures six dimensions of social support: 1) emotional support, 2) tangible and material help, 3) advice, 4) social integration, 5) self-esteem and 6) the need to feel useful and needed.

  11. The Posttraumatic Stress Disorder Checklist Scale-version DSM-5 (PCL-5; Weathers, Litz et al., 2013) [ Time Frame: Baseline, changes from baseline at every 4-sessions during treatment (i.e. session 4, 8 … 28 - the number of assessments during treatment will vary based on the number of sessions), 1 week, 3 months, 6 months and 1 year post-treatment. ]
    PCL-5 will be used as a follow-up measure to assess PTSD symptoms in the last month according to the DSM-5.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019497


Contacts
Contact: Stéphane Guay, PhD 5142514000 ext 3084 stephane.guay@umontreal.ca

Locations
Canada, Quebec
Stephane Guay Not yet recruiting
Montreal, Quebec, Canada, H1N 3V2
Contact: Jane Goncalves, PHD    1-514-251-4015 ext 2495    jgoncalves.iusmm@ssss.gouv.qc.ca   
Contact: Isabelle Bernier    1-514-251-4015 ext 3734    ibernier.iusmm@ssss.gouv.qc.ca   
Principal Investigator: Stephane Guay, PHD         
Sponsors and Collaborators
Université de Montréal
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Investigators
Principal Investigator: Stéphane Guay, PhD Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

Publications:
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.
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.

Responsible Party: Stephane Guay, Professor, Université de Montréal
ClinicalTrials.gov Identifier: NCT03019497     History of Changes
Other Study ID Numbers: 365935
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Stephane Guay, Université de Montréal:
Major depression
PTSD
Related Problems
Therapy
Traumatic Event
Quality of Life
Cognitive Behavioral Therapy (CBT)
Sleep disorders
Pain
Stressors
Social support
Substance use disorder
Anxiety disorder

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders