IRT and CBT in Sexual Assault Victims With PTSD

NCT ID: NCT03169712

Last Updated: 2023-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-20

Study Completion Date

2016-08-01

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.

Detailed Description

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Conditions

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Stress Disorders, Post-Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CBT for PTSD

15 sessions of trauma-focused CBT

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy for PTSD

Intervention Type 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 + CBT for PTSD

5 sessions of IRT + 15 sessions of trauma-focused CBT

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy for PTSD

Intervention Type 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

Intervention Type BEHAVIORAL

IRT protocol published by Nappi and collaborators (2010)

Interventions

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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)

Intervention Type BEHAVIORAL

Imagery Rehearsal Therapy

IRT protocol published by Nappi and collaborators (2010)

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laval University

OTHER

Sponsor Role lead

Responsible Party

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Geneviève Belleville

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Geneviève Belleville

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

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Service de Consultation de l'École de Psychologie

Québec, Quebec, Canada

Site Status

Countries

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Canada

References

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O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.

Reference Type DERIVED
PMID: 37795783 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30070398 (View on PubMed)

Other Identifiers

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000000

Identifier Type: -

Identifier Source: org_study_id

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