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Completed

NCT Number: NCT03169712

IRT and CBT in Sexual Assault Victims With PTSD

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.

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Key information

Conditions

Stress Disorders, Post-Traumatic Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Consultation de l'École de Psychologie

Québec, Quebec, G1V 0A6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Imagery Rehearsal Therapy

Behavioral

IRT protocol published by Nappi and collaborators (2010)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
May 30, 2017
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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