Post-traumatic Stress DisorderPhase 2/3NCT00669981
Effectiveness of Cognitive Behavioral Couples Therapy for Post-traumatic Stress Disorder
A Phase 2/3 study testing Cognitive behavioral couples therapy for post-traumatic stress disorder (CBCT for PTSD) in people with Post-traumatic Stress Disorder, run by Toronto Metropolitan University at 2 sites in 2 countries.
Trial summary
This study will evaluate the effectiveness of cognitive behavioral couples therapy designed for post-traumatic stress disorder in reducing symptoms of post-traumatic stress disorder and in improving relationship functioning. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Cognitive behavioral couples therapy for post-traumatic stress disorder (CBCT for PTSD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2008to Jun 2012
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current diagnosis of PTSD
- An intimate partner willing to participate in treatment
Who cannot join
- Both partners have PTSD
- Either partner with substance dependence not in remission for at least 3 months before study entry, current uncontrolled bipolar or psychotic disorder, or severe cognitive impairment
- Couple currently experiencing severe intimate aggression or a desire to separate or end their intimate relationship
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
VA Boston Healthcare System
Boston, Massachusetts, 02130
About this study
Official title: Cognitive-Behavioral Couples Therapy for Posttraumatic Stress Disorder
This study will evaluate the effectiveness of cognitive behavioral couples therapy designed for post-traumatic stress disorder in reducing symptoms of post-traumatic stress disorder and in improving relationship functioning.
Read the detailed description
Post-traumatic stress disorder (PTSD) is a highly prevalent and disabling disorder that affects about 7.7 million adults in the United States. PTSD can develop after someone experiences a particularly distressing event that may involve the threat of or actual physical harm. Common symptoms of PTSD include avoidance of situations or cues that may act as reminders of the event, reoccurring flashbacks of the event, loss of interest in previously enjoyed activities, and numbing of emotions. Additionally, PTSD is often associated with far-reaching and devastating interpersonal relationship problems that can maintain or aggravate other PTSD symptoms. These interpersonal problems can also interfere with successful treatment delivery, so addressing such problems is important for improving treatment compliance, effectiveness, and long-term success. Cognitive behavioral therapy (CBT) is a type of psychotherapy that teaches ways to modify thoughts and behaviors that contribute to PTSD. CBT that is adapted for couples in which one partner has PTSD may be the most effective means of decreasing individual PTSD symptoms and improving the couple's relationship. This study will evaluate the effectiveness of cognitive behavioral couples therapy (CBCT) for PTSD in reducing symptoms of PSTD and in improving relationship functioning for couples in which one partner has PTSD.
Participation in this study will last 8 months. All participants will undergo baseline assessments that will include an interview about exposure to traumatic events, PTSD symptoms, mental health problems, and substance use; self-report questionnaires about mood, social and leisure activities, and relationships; and a brief video-recorded communication session as a couple. Eligible participants will then be assigned randomly to receive immediate CBCT for PTSD or delayed CBCT for PTSD. Participants in the delayed treatment group will receive active treatment after a 3-month waitlist period. CBCT for PTSD will include fifteen 75-minute couples therapy sessions, occurring twice weekly for 3 weeks and weekly for the remaining 9 weeks of treatment. Sessions will follow manual-based couples therapy and will aim to both decrease individual PTSD symptoms and enhance dyadic functioning. After each session, participants will also complete out-of-session practice assignments that will include completing worksheets and practicing skills taught in therapy sessions.
Participants receiving immediate CBCT for PTSD will undergo subsequent assessments at mid-treatment, end of treatment, and 3 months after the end of treatment. Participants receiving delayed treatment will undergo assessments 1 and 3 months into the wait-list period and at the end of treatment. Assessments will include questions about PTSD and mental health symptoms, alcohol and substance use, intimate relationship functioning, and family and social activities. Participants will repeat the communication session after the end of treatment for the group receiving immediate therapy and at the end of the wait-list period for the delayed treatment group.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- Cognitive behavioral couples therapy for post-traumatic stress disorder (CBCT for PTSD)
- Keywords
- PTSD, Relationship Distress, Couple 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 couples therapy for post-traumatic stress disorder (CBCT for PTSD)Behavioural
CBCT for PTSD is a 15-session manualized couples therapy that aims to both decrease individual PTSD symptoms and improve dyadic functioning.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive immediate cognitive behavioral couples therapy for PTSD. Receives: Behavioral: Cognitive behavioral couples therapy for post-traumatic stress disorder (CBCT for PTSD) |
| 2 | Active comparator | Participants will receive delayed cognitive behavioral couples therapy for PTSD after a 3-month waitlist period. Receives: Behavioral: Cognitive behavioral couples therapy for post-traumatic stress disorder (CBCT for PTSD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-Administered PTSD Scale
Measured: Measured at pre-treatment, mid-treatment, post-treatment, and 3-month follow-up
Secondary outcomes (1)
Dyadic Adjustment Scale
Measured: Measured at pre-treatment, mid-treatment, post-treatment, and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Candice Monson, Toronto Metropolitan University
- Investigators
- Candice M. Monson, PhD, Principal investigator, Toronto Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669981
- Sponsor's protocol ID
- R34MH076813
- Other IDs
- R34MH076813, DSIR 83-ATAS
- Status last verified
- Nov 2013
- First submitted
- 29 Apr 2008
- Last updated
- 26 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Monson CM, Schnurr PP, Stevens SP, Guthrie KA. Cognitive-Behavioral Couple's Treatment for posttraumatic stress disorder: initial findings. J Trauma Stress. 2004 Aug;17(4):341-4. doi: 10.1023/B:JOTS.0000038483.69570.5b.
PubMed 15462542Monson CM, Fredman SJ, Adair KC. Cognitive-behavioral conjoint therapy for posttraumatic stress disorder: application to operation enduring and Iraqi Freedom veterans. J Clin Psychol. 2008 Aug;64(8):958-71. doi: 10.1002/jclp.20511.
PubMed 18613094Monson CM, Fredman SJ, Macdonald A, Pukay-Martin ND, Resick PA, Schnurr PP. Effect of cognitive-behavioral couple therapy for PTSD: a randomized controlled trial. JAMA. 2012 Aug 15;308(7):700-9. doi: 10.1001/jama.2012.9307.
PubMed 22893167
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-Behavioral Couples Therapy for Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00669981
- Acronym / sponsor ID
- R34MH076813
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- PTSD, Relationship Distress, Couple Therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 1 May 2008 (estimated)
- 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.
This study will evaluate the effectiveness of cognitive behavioral couples therapy designed for post-traumatic stress disorder in reducing symptoms of post-traumatic stress disorder and in improving relationship functioning.
Detailed description
Post-traumatic stress disorder (PTSD) is a highly prevalent and disabling disorder that affects about 7.7 million adults in the United States. PTSD can develop after someone experiences a particularly distressing event that may involve the threat of or actual physical harm. Common symptoms of PTSD include avoidance of situations or cues that may act as reminders of the event, reoccurring flashbacks of the event, loss of interest in previously enjoyed activities, and numbing of emotions. Additionally, PTSD is often associated with far-reaching and devastating interpersonal relationship problems that can maintain or aggravate other PTSD symptoms. These interpersonal problems can also interfere with successful treatment delivery, so addressing such problems is important for improving treatment compliance, effectiveness, and long-term success. Cognitive behavioral therapy (CBT) is a type of psychotherapy that teaches ways to modify thoughts and behaviors that contribute to PTSD. CBT that is adapted for couples in which one partner has PTSD may be the most effective means of decreasing individual PTSD symptoms and improving the couple's relationship. This study will evaluate the effectiveness of cognitive behavioral couples therapy (CBCT) for PTSD in reducing symptoms of PSTD and in improving relationship functioning for couples in which one partner has PTSD.
Participation in this study will last 8 months. All participants will undergo baseline assessments that will include an interview about exposure to traumatic events, PTSD symptoms, mental health problems, and substance use; self-report questionnaires about mood, social and leisure activities, and relationships; and a brief video-recorded communication session as a couple. Eligible participants will then be assigned randomly to receive immediate CBCT for PTSD or delayed CBCT for PTSD. Participants in the delayed treatment group will receive active treatment after a 3-month waitlist period. CBCT for PTSD will include fifteen 75-minute couples therapy sessions, occurring twice weekly for 3 weeks and weekly for the remaining 9 weeks of treatment. Sessions will follow manual-based couples therapy and will aim to both decrease individual PTSD symptoms and enhance dyadic functioning. After each session, participants will also complete out-of-session practice assignments that will include completing worksheets and practicing skills taught in therapy sessions.
Participants receiving immediate CBCT for PTSD will undergo subsequent assessments at mid-treatment, end of treatment, and 3 months after the end of treatment. Participants receiving delayed treatment will undergo assessments 1 and 3 months into the wait-list period and at the end of treatment. Assessments will include questions about PTSD and mental health symptoms, alcohol and substance use, intimate relationship functioning, and family and social activities. Participants will repeat the communication session after the end of treatment for the group receiving immediate therapy and at the end of the wait-list period for the delayed treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Cognitive behavioral couples therapy for post-traumatic stress disorder (CBCT for PTSD)Participants will receive immediate cognitive behavioral couples therapy for PTSD. |
| 2 | Active comparator | Behavioral: Cognitive behavioral couples therapy for post-traumatic stress disorder (CBCT for PTSD)Participants will receive delayed cognitive behavioral couples therapy for PTSD after a 3-month waitlist period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Current diagnosis of PTSD
- An intimate partner willing to participate in treatment
Key exclusion criteria (3 listed)
- Both partners have PTSD
- Either partner with substance dependence not in remission for at least 3 months before study entry, current uncontrolled bipolar or psychotic disorder, or severe cognitive impairment
- Couple currently experiencing severe intimate aggression or a desire to separate or end their intimate relationship
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 couples therapy for post-traumatic stress disorder (CBCT for PTSD)CBCT for PTSD is a 15-session manualized couples therapy that aims to both decrease individual PTSD symptoms and improve dyadic functioning. | Behavioural | 1, 2 |
Primary outcome
Clinician-Administered PTSD Scale
Time frame: Measured at pre-treatment, mid-treatment, post-treatment, and 3-month follow-up
1 secondary outcome
Dyadic Adjustment Scale
Time frame: Measured at pre-treatment, mid-treatment, post-treatment, and 3-month follow-up
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 26 Nov 2013.
- Background: PubMed 15462542Monson CM, Schnurr PP, Stevens SP, Guthrie KA. Cognitive-Behavioral Couple's Treatment for posttraumatic stress disorder: initial findings. J Trauma Stress. 2004 Aug;17(4):341-4. doi: 10.1023/B:JOTS.0000038483.69570.5b.
- Background: PubMed 18613094Monson CM, Fredman SJ, Adair KC. Cognitive-behavioral conjoint therapy for posttraumatic stress disorder: application to operation enduring and Iraqi Freedom veterans. J Clin Psychol. 2008 Aug;64(8):958-71. doi: 10.1002/jclp.20511.
- Derived from this study: PubMed 22893167Monson CM, Fredman SJ, Macdonald A, Pukay-Martin ND, Resick PA, Schnurr PP. Effect of cognitive-behavioral couple therapy for PTSD: a randomized controlled trial. JAMA. 2012 Aug 15;308(7):700-9. doi: 10.1001/jama.2012.9307.
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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.
Candice M. Monson, PhD principal investigator
Toronto Metropolitan University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cognitive behavioral couples therapy for post-traumatic stress disorder (CBCT for PTSD) in people with Post-traumatic Stress Disorder, run by Toronto Metropolitan University at 2 sites in 2 countries.
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 2 inclusion and 3 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 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinician-Administered PTSD Scale (time frame: Measured at pre-treatment, mid-treatment, post-treatment, and 3-month follow-up). 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 NCT00669981, which also lists 3 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 26 Nov 2013.