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IRT and CBT in Sexual Assault Victims With PTSD

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ClinicalTrials.gov Identifier: NCT03169712
Recruitment Status : Completed
First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Geneviève Belleville, Laval University

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.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Behavioral: Cognitive Behavioral Therapy for PTSD Behavioral: Imagery Rehearsal Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Sequential Imagery Rehearsal Therapy and Cognitive-Behavioural Therapy in Sexual Assault Victims With Posttraumatic Stress Disorder: a Randomized Control Trial
Actual Study Start Date : December 20, 2012
Actual Primary Completion Date : May 1, 2016
Actual Study Completion Date : August 1, 2016

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Change in Pittsburgh Sleep Quality Index total score [ Time Frame: 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 ]
    Self-report questionnaire

  2. Change in Modified PTSD Symptom Scale - Self Report total score [ Time Frame: 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 ]
    Self-report questionnaire


Secondary Outcome Measures :
  1. Change in Nightmare Distress Questionnaire total score [ Time Frame: 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 ]
    Self-report questionnaire

  2. Change in Pittsburgh Sleep Quality Index - Addendum for PTSD total score [ Time Frame: 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 ]
    Self-report questionnaire

  3. Change in World Health Organization Disability Assessment Schedule total and subscale scores [ Time Frame: 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 ]
    Self-report questionnaire

  4. Change in Medical Outcomes Study Health Survey subscale scores [ Time Frame: 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 ]
    Self-report questionnaire

  5. Change in Beliefs About Psychological Service total score [ Time Frame: 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 ]
    Self-report questionnaire

  6. Change in Working Alliance Inventory subscale scores [ Time Frame: 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 ]
    Self-report questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03169712


Locations
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Canada, Quebec
Service de Consultation de l'École de Psychologie
Québec, Quebec, Canada, G1V 0A6
Sponsors and Collaborators
Laval University
Investigators
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Principal Investigator: Geneviève Belleville Laval University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Geneviève Belleville, Associate Professor, Laval University
ClinicalTrials.gov Identifier: NCT03169712    
Other Study ID Numbers: 000000
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders