IRT and CBT in Sexual Assault Victims With PTSD

Efficacy of Sequential Imagery Rehearsal Therapy and Cognitive-Behavioural Therapy in Sexual Assault Victims With Posttraumatic Stress Disorder: a Randomized Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Stress Disorders, Post-Traumatic
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy for PTSD; Behavioral: Imagery Rehearsal Therapy

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V 0A6
      • Service de Consultation de l'École de Psychologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CBT for PTSD; 15 sessions of trauma-focused CBT	Behavioral: Cognitive Behavioral Therapy for PTSD; 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)
Experimental: Imagery Rehearsal Therapy + CBT for PTSD; 5 sessions of IRT + 15 sessions of trauma-focused CBT	Behavioral: Cognitive Behavioral Therapy for PTSD; 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); Behavioral: Imagery Rehearsal Therapy; IRT protocol published by Nappi and collaborators (2010)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pittsburgh Sleep Quality Index total score	Self-report questionnaire	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
Change in Modified PTSD Symptom Scale - Self Report total score	Self-report questionnaire	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 Measures

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

Collaborators and Investigators

• Sponsor: Laval University
• Investigators: Principal Investigator: Geneviève Belleville, Laval University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2012
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 000000 (MRDC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No