Stress Disorders, Post-TraumaticNCT03169712

IRT and CBT in Sexual Assault Victims With PTSD

A study testing Cognitive Behavioral Therapy for PTSD and Imagery Rehearsal Therapy in people with Stress Disorders, Post-Traumatic, run by Laval University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 120 years
Conditions the study is for: Stress Disorders, Post-Traumatic
What is being tested?: Cognitive Behavioral Therapy for PTSD and Imagery Rehearsal Therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteCanada
Study dates: 20 Dec 2012to 1 Aug 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 120 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Service de Consultation de l'École de Psychologie
Québec, Quebec, G1V 0A6

Other trials in Canada

About this study

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

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.

Conditions: Stress Disorders, Post-Traumatic
Being tested: Cognitive Behavioral Therapy for PTSD, Imagery Rehearsal Therapy
Medical subject headings: Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive Behavioral Therapy for PTSDBehavioural
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 TherapyBehavioural
IRT protocol published by Nappi and collaborators (2010)

Study groups in NCT03169712
Study group	Role	What they receive
CBT for PTSD	Active comparator	15 sessions of trauma-focused CBT Receives: Behavioral: Cognitive Behavioral Therapy for PTSD
Imagery Rehearsal Therapy + CBT for PTSD	Experimental	5 sessions of IRT + 15 sessions of trauma-focused CBT Receives: Behavioral: Cognitive Behavioral Therapy for PTSD; Behavioral: Imagery Rehearsal Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Pittsburgh Sleep Quality Index total score
Self-report questionnaire
Measured: 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
Change in Modified PTSD Symptom Scale - Self Report total score
Self-report questionnaire
Measured: 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 (6)

Change in Nightmare Distress Questionnaire total score
Self-report questionnaire
Measured: 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
Change in Pittsburgh Sleep Quality Index - Addendum for PTSD total score
Self-report questionnaire
Measured: 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
Change in World Health Organization Disability Assessment Schedule total and subscale scores
Self-report questionnaire
Measured: 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
Change in Medical Outcomes Study Health Survey subscale scores
Self-report questionnaire
Measured: 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
Change in Beliefs About Psychological Service total score
Self-report questionnaire
Measured: 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
Change in Working Alliance Inventory subscale scores
Self-report questionnaire
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Dec 20121 Aug 2016

First posted30 May 2017
Study start20 Dec 2012
Primary completion1 May 2016
Study completion1 Aug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
More trials run by Laval UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03169712
Sponsor's protocol ID: 000000
Status last verified: Oct 2023
First submitted: 23 May 2017
Last updated: 6 Oct 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 37795783
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.
PubMed 30070398

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
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All Stress Disorders, Post-Traumatic trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Sequential Imagery Rehearsal Therapy and Cognitive-Behavioural Therapy in Sexual Assault Victims With Posttraumatic Stress Disorder: a Randomized Control Trial
ClinicalTrials.gov ID: NCT03169712
Acronym / sponsor ID: 000000
Conditions: Stress Disorders, Post-Traumatic
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Laval UniversityUniversity, hospital or other
Study start: 20 Dec 2012 (actual)
Primary completion: 1 May 2016 (actual)
Study completion: 1 Aug 2016 (actual)
First posted: 30 May 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
CBT for PTSD	Active comparator	Behavioral: Cognitive Behavioral Therapy for PTSD15 sessions of trauma-focused CBT
Imagery Rehearsal Therapy + CBT for PTSD	Experimental	Behavioral: Cognitive Behavioral Therapy for PTSD, Behavioral: Imagery Rehearsal Therapy5 sessions of IRT + 15 sessions of trauma-focused CBT

Who may qualify

Ages: 18 to 120 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cognitive Behavioral Therapy for PTSDTrauma-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)	Behavioural	CBT for PTSD, Imagery Rehearsal Therapy + CBT for PTSD
Imagery Rehearsal TherapyIRT protocol published by Nappi and collaborators (2010)	Behavioural	Imagery Rehearsal Therapy + CBT for PTSD

Primary outcome

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
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

6 secondary outcomes

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
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
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
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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
Derived from this study: PubMed 37795783O'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.
Derived from this study: PubMed 30070398Belleville 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.
Individual participant dataSharing planned: No

Related trials for Stress Disorders, Post-Traumatic

Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
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RecruitingPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Geneviève Belleville principal investigator

Laval University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy for PTSD and Imagery Rehearsal Therapy in people with Stress Disorders, Post-Traumatic, run by Laval University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03169712, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.