IRT and CBT in Sexual Assault Victims With PTSD

Study Overview
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Brief Summary
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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.

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

Conditions
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Stress Disorders, Post-Traumatic

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for PTSD
* Behavioral: Imagery Rehearsal Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |