Clinical trial NCT03169712: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Pittsburgh Sleep Quality Index total score
timeFrame: 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
measure: Change in Modified PTSD Symptom Scale - Self Report total score
timeFrame: 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:
measure: Change in Nightmare Distress Questionnaire total score
timeFrame: 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
measure: Change in Pittsburgh Sleep Quality Index - Addendum for PTSD total score
timeFrame: 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
measure: Change in World Health Organization Disability Assessment Schedule total and subscale scores
timeFrame: 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
measure: Change in Medical Outcomes Study Health Survey subscale scores
timeFrame: 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
measure: Change in Beliefs About Psychological Service total score
timeFrame: 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
measure: Change in Working Alliance Inventory subscale scores
timeFrame: 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
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Service de Consultation de l'École de Psychologie
state: Quebec
Study officials:
affiliation: Laval University
name: Geneviève Belleville
role: PRINCIPAL_INVESTIGATOR
References:
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.