IRT and CBT in Sexual Assault Victims With PTSD

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03169712
• Other study ID #: 000000
• Status: Completed
• Phase: N/A
• Start date: December 20, 2012
• Est. completion date: August 1, 2016

Study information

• Verified date: October 2023
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 1, 2016
• Est. primary completion date: May 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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)
• Imagery Rehearsal Therapy
IRT protocol published by Nappi and collaborators (2010)

Locations

Country	Name	City	State
Canada	Service de Consultation de l'École de Psychologie	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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