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IRT and CBT in Sexual Assault Victims With PTSD

Primary Purpose

Stress Disorders, Post-Traumatic

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for PTSD
Imagery Rehearsal Therapy
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • over 18 years of age;
  • able to understand and speak French;
  • history of unwanted sexual experience;
  • PTSD diagnosis according to DSM-IV-TR;
  • sleep complaints, as established by Pittsburgh Sleep Quality Index score ≥ 5 and a mean of one or more NM per week for at least one month;
  • if psychotropic medication was used, (antidepressant, antianxiety, antipsychotic or hypnotic medication) stable for a minimum of three months;
  • available for in-person assessments and therapy sessions.

Exclusion Criteria:

  • past or present psychotic episode, bipolar disorder or organic mental disorder (e.g. dementia);
  • substance use disorder;
  • sleep apnea diagnosis;
  • use of prazosine to treat nightmares;
  • presently in treatment for psychological difficulties;
  • significant suicidal thoughts requiring immediate intervention.

Sites / Locations

  • Service de Consultation de l'École de Psychologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CBT for PTSD

Imagery Rehearsal Therapy + CBT for PTSD

Arm Description

15 sessions of trauma-focused CBT

5 sessions of IRT + 15 sessions of trauma-focused CBT

Outcomes

Primary Outcome Measures

Change in Pittsburgh Sleep Quality Index total score
Self-report questionnaire
Change in Modified PTSD Symptom Scale - Self Report total score
Self-report questionnaire

Secondary Outcome Measures

Change in Nightmare Distress Questionnaire total score
Self-report questionnaire
Change in Pittsburgh Sleep Quality Index - Addendum for PTSD total score
Self-report questionnaire
Change in World Health Organization Disability Assessment Schedule total and subscale scores
Self-report questionnaire
Change in Medical Outcomes Study Health Survey subscale scores
Self-report questionnaire
Change in Beliefs About Psychological Service total score
Self-report questionnaire
Change in Working Alliance Inventory subscale scores
Self-report questionnaire

Full Information

First Posted
May 23, 2017
Last Updated
October 5, 2023
Sponsor
Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT03169712
Brief Title
IRT and CBT in Sexual Assault Victims With PTSD
Official Title
Efficacy of Sequential Imagery Rehearsal Therapy and Cognitive-Behavioural Therapy in Sexual Assault Victims With Posttraumatic Stress Disorder: a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
December 20, 2012 (Actual)
Primary Completion Date
May 1, 2016 (Actual)
Study Completion Date
August 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Sexual assault victims (SAV) have an elevated risk of developing posttraumatic stress disorder (PTSD). Trauma-focused cognitive-behavioural therapy (CBT) is an effective first-line treatment for this pathology. However, although sleep disturbances are a common complaint in SAV with PTSD, trauma-focused CBT does not directly address this symptom. Posttraumatic nightmares are widespread among SAV. Trauma-related sleep disturbances are associated with significant impairment in general functioning and quality of life (mental and physical health), and contribute to the maintenance of PTSD symptoms. This study evaluates the efficacy of sequential nightmare therapy (imagery rehearsal therapy; IRT) and trauma-focused CBT, in comparison to CBT alone. Forty-two SAV suffering from PTSD and sleep difficulties were recruited and randomly assigned to the experimental (IRT+CBT) or control condition (waiting period followed by CBT alone). Participants were administered a clinical interview and a series of questionnaires assessing PTSD symptoms, general functioning and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT for PTSD
Arm Type
Active Comparator
Arm Description
15 sessions of trauma-focused CBT
Arm Title
Imagery Rehearsal Therapy + CBT for PTSD
Arm Type
Experimental
Arm Description
5 sessions of IRT + 15 sessions of trauma-focused CBT
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for PTSD
Intervention Description
Trauma-focused CBT protocol elaborated by Marchand and Guay from the Trauma Studies Centre at Louis-H. Lafontaine Hospital in Montreal and adapted from Foa, Hembree and Rothbaum (2007)
Intervention Type
Behavioral
Intervention Name(s)
Imagery Rehearsal Therapy
Intervention Description
IRT protocol published by Nappi and collaborators (2010)
Primary Outcome Measure Information:
Title
Change in Pittsburgh Sleep Quality Index total score
Description
Self-report questionnaire
Time Frame
Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU
Title
Change in Modified PTSD Symptom Scale - Self Report total score
Description
Self-report questionnaire
Time Frame
Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU
Secondary Outcome Measure Information:
Title
Change in Nightmare Distress Questionnaire total score
Description
Self-report questionnaire
Time Frame
Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU
Title
Change in Pittsburgh Sleep Quality Index - Addendum for PTSD total score
Description
Self-report questionnaire
Time Frame
Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU
Title
Change in World Health Organization Disability Assessment Schedule total and subscale scores
Description
Self-report questionnaire
Time Frame
Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU
Title
Change in Medical Outcomes Study Health Survey subscale scores
Description
Self-report questionnaire
Time Frame
Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU
Title
Change in Beliefs About Psychological Service total score
Description
Self-report questionnaire
Time Frame
Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU
Title
Change in Working Alliance Inventory subscale scores
Description
Self-report questionnaire
Time Frame
Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: over 18 years of age; able to understand and speak French; history of unwanted sexual experience; PTSD diagnosis according to DSM-IV-TR; sleep complaints, as established by Pittsburgh Sleep Quality Index score ≥ 5 and a mean of one or more NM per week for at least one month; if psychotropic medication was used, (antidepressant, antianxiety, antipsychotic or hypnotic medication) stable for a minimum of three months; available for in-person assessments and therapy sessions. Exclusion Criteria: past or present psychotic episode, bipolar disorder or organic mental disorder (e.g. dementia); substance use disorder; sleep apnea diagnosis; use of prazosine to treat nightmares; presently in treatment for psychological difficulties; significant suicidal thoughts requiring immediate intervention.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geneviève Belleville
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Consultation de l'École de Psychologie
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30070398
Citation
Belleville G, Dube-Frenette M, Rousseau A. Efficacy of Imagery Rehearsal Therapy and Cognitive Behavioral Therapy in Sexual Assault Victims With Posttraumatic Stress Disorder: A Randomized Controlled Trial. J Trauma Stress. 2018 Aug;31(4):591-601. doi: 10.1002/jts.22306. Epub 2018 Aug 2.
Results Reference
derived

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IRT and CBT in Sexual Assault Victims With PTSD

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