IRT and CBT in Sexual Assault Victims With PTSD

NCT03169712 | Completed

• 1 other identifier: 000000
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change in Nightmare Distress Questionnaire total score

  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

  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

  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

  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

  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

Study Arms (2)

CBT for PTSD

ACTIVE COMPARATOR

15 sessions of trauma-focused CBT

Behavioral: Cognitive Behavioral Therapy for PTSD

Imagery Rehearsal Therapy + CBT for PTSD

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Therapy for PTSD; Behavioral: Imagery Rehearsal Therapy

Interventions

Cognitive Behavioral Therapy for PTSD BEHAVIORAL

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)

CBT for PTSD; Imagery Rehearsal Therapy + CBT for PTSD

Imagery Rehearsal Therapy BEHAVIORAL

IRT protocol published by Nappi and collaborators (2010)

Imagery Rehearsal Therapy + CBT for PTSD

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Service de Consultation de l'École de Psychologie

Québec, Quebec, G1V 0A6, Canada

Location

Related Publications (2)

• 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

• 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.

  PMID: 30070398 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Geneviève Belleville

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 30, 2017
• Study Start: December 20, 2012
• Primary Completion: May 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)