PTSDNCT03158558
Intensive Weekend Retreat Multi-Couple Group Therapy for PTSD
A study testing Accelerated, Multi-Couple Group CBCT for PTSD in people with PTSD, run by Penn State University at 1 site in United States.
Trial summary
The purpose of this study is to test an intensive, multi-couple group version of a couple therapy for PTSD delivered to active duty Service Members or Veterans with PTSD and their romantic partners in a single weekend retreat. The study will be conducted on or near Fort Hood in Kileen, Texas. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD
- What is being tested?
- Accelerated, Multi-Couple Group CBCT for PTSD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Feb 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Married or cohabitating couples who have been together the past 3 months in which one partner is a Service Member or recently discharged Veterans eligible for treatment at Carl R. Darnall Army Medical Center (CRDAMC) with PTSD who has deployed since 9/11, seeking treatment for PTSD.
- Diagnosis of PTSD as determined by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and a CAPS-5 score > 25. The Service Member or Veteran with PTSD must have experienced a Criterion A event that is a specific combat-related event or high magnitude operational experience that occurred during a military deployment in support of combat operations following 9/11. The diagnosis of PTSD may be indexed to that event or to another Criterion A event.
- Both individuals must be able to speak and read English.
Who cannot join
- Couple is separated and/or has taken steps to dissolve their relationship (e.g., divorce)
- Currently participating in evidence-based treatment for PTSD (Prolonged Exposure, Cognitive Processing Therapy, or Cognitive-Behavioral Conjoint Therapy for PTSD).
- Recent manic episode (past 12 months) or a psychotic disorder (as determined by the Mania and Psychosis modules of the MINI)
- Current alcohol dependence (as determined by an a score of ≥ 4 on items #4-6 and a total score of ≥20 on the AUDIT)
- Evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires)
- Current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index - Suicidality Subscale; DSI-SS)
- Evidence or admission of severe intimate aggression as indicated by a "yes" endorsement to the one-question Screen for Conflict Question by either member of the couple occurring within the past 6-months.
- Partner who meets diagnostic criteria for PTSD according to the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) or PTSD Checklist - Stressor Specific (PCL-S).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Sciences Center San Antonio
Killeen, Texas, 76544
About this study
Official title: Multi-Couple Group Intervention for PTSD
The purpose of this study is to test an intensive, multi-couple group version of a couple therapy for PTSD delivered to active duty Service Members or Veterans with PTSD and their romantic partners in a single weekend retreat. The study will be conducted on or near Fort Hood in Kileen, Texas. Twenty-four couples will be treated with this therapy and assessed immediately before treatment, 1 month after treatment, and 3 months after treatment.
Read the detailed description
Numerous studies have documented an association between posttraumatic stress disorder (PTSD) symptoms and intimate relationship problems in both Service Members and Veterans and their partners, including relationship distress, physical and psychological aggression, and psychological distress in partners. In prior work, the investigators have demonstrated that cognitive-behavioral conjoint therapy for PTSD (CBCT for PTSD), a 15-session couple-based therapy for PTSD, is efficacious in simultaneously treating PTSD and comorbid symptoms and improving intimate relationship functioning. However, the current format of fifteen 75-minute sessions over 15 weeks presents challenges for large-scale dissemination for active duty Service Members and recently discharged Veterans who have deployed in support of 9/11.
The purpose of this uncontrolled trial is to pilot a brief, scalable version of CBCT for PTSD in which session content is taught in an accelerated, multi-couple group format (AM-CBCT for PTSD) that has the potential for rapid dissemination and implementation, while capturing the majority of the benefits of the original therapy format. Accelerated, multi-couple group CBCT for PTSD (AM-CBCT for PTSD) will be delivered in a single weekend retreat to 24 active duty Service Members and recently discharged Veterans with PTSD who have deployed post-9/11 and their partners. Participants will be assessed at pre-treatment, one month after treatment, and 3 months after treatment.
The study seeks to answer the following questions:
- Will accelerated, multi-couple group CBCT for PTSD delivered in a weekend retreat (AM-CBCT for PTSD) be associated with significant improvements in clinician-rated PTSD symptom severity, as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), one month after treatment and at 3-month follow-up?
- Will accelerated, multi-couple group CBCT for PTSD delivered in a weekend retreat (AM-CBCT for PTSD) be associated with significant improvements in secondary outcomes (e.g., patient self-reported PTSD and comorbid symptom severity, relationship satisfaction), one month after treatment and at 3-month follow-up?
- Conditions
- PTSD
- Being tested
- Accelerated, Multi-Couple Group CBCT for PTSD
- 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.
Accelerated, Multi-Couple Group CBCT for PTSDBehavioural
Also called AM-CBCT for PTSD
Intensive weekend retreat version of cognitive-behavioral conjoint therapy for PTSD (Monson \& Fredman, 2012)
| Study group | Role | What they receive |
|---|---|---|
| AM-CBCT for PTSD | Experimental | Accelerated, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy delivered in a single weekend retreat Receives: Behavioral: Accelerated, Multi-Couple Group CBCT for PTSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale (CAPS-5)
semi-structured clinician interview to determine presence and severity of PTSD symptoms
Measured: change in PTSD symptoms at 1 and 3 months posttreatment
Secondary outcomes (3)
PTSD Checklist for DSM-5 (PCL-5)
patient self-report rating of PTSD symptom severity
Measured: change in PTSD symptoms at 1 and 3 months posttreatment
Patient Health Questionnaire-9 (PHQ-9)
self-report measure of depressive symptom severity
Measured: change in PTSD symptoms at 1 and 3 months posttreatment
Couples Satisfaction Index (CSI)
self-report measure of relationship satisfaction
Measured: change in relationship satisfaction at 1 and 3 months posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study startSep 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Penn State 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, US Department of Veterans Affairs, The University of Texas Health Science Center at San Antonio, The Citadel, Toronto Metropolitan University, University of Denver, Duke University, VA Boston Healthcare System
- Responsible party
- Principal investigator, Steffany J Fredman, Ph.D., Penn State University
- Investigators
- Steffany J. Fredman, Ph.D., Principal investigator, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158558
- Sponsor's protocol ID
- HSC20160094H
- Status last verified
- Dec 2018
- First submitted
- 15 May 2017
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Couple Group Intervention for PTSD
- ClinicalTrials.gov ID
- NCT03158558
- Acronym / sponsor ID
- HSC20160094H
- Conditions
- PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense, US Department of Veterans Affairs, The University of Texas Health Science Center at San Antonio, The Citadel, Toronto Metropolitan University, University of Denver, Duke University, VA Boston Healthcare System
- Study start
- Sep 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 18 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.
The purpose of this study is to test an intensive, multi-couple group version of a couple therapy for PTSD delivered to active duty Service Members or Veterans with PTSD and their romantic partners in a single weekend retreat. The study will be conducted on or near Fort Hood in Kileen, Texas. Twenty-four couples will be treated with this therapy and assessed immediately before treatment, 1 month after treatment, and 3 months after treatment.
Detailed description
Numerous studies have documented an association between posttraumatic stress disorder (PTSD) symptoms and intimate relationship problems in both Service Members and Veterans and their partners, including relationship distress, physical and psychological aggression, and psychological distress in partners. In prior work, the investigators have demonstrated that cognitive-behavioral conjoint therapy for PTSD (CBCT for PTSD), a 15-session couple-based therapy for PTSD, is efficacious in simultaneously treating PTSD and comorbid symptoms and improving intimate relationship functioning. However, the current format of fifteen 75-minute sessions over 15 weeks presents challenges for large-scale dissemination for active duty Service Members and recently discharged Veterans who have deployed in support of 9/11.
The purpose of this uncontrolled trial is to pilot a brief, scalable version of CBCT for PTSD in which session content is taught in an accelerated, multi-couple group format (AM-CBCT for PTSD) that has the potential for rapid dissemination and implementation, while capturing the majority of the benefits of the original therapy format. Accelerated, multi-couple group CBCT for PTSD (AM-CBCT for PTSD) will be delivered in a single weekend retreat to 24 active duty Service Members and recently discharged Veterans with PTSD who have deployed post-9/11 and their partners. Participants will be assessed at pre-treatment, one month after treatment, and 3 months after treatment.
The study seeks to answer the following questions:
- Will accelerated, multi-couple group CBCT for PTSD delivered in a weekend retreat (AM-CBCT for PTSD) be associated with significant improvements in clinician-rated PTSD symptom severity, as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), one month after treatment and at 3-month follow-up?
- Will accelerated, multi-couple group CBCT for PTSD delivered in a weekend retreat (AM-CBCT for PTSD) be associated with significant improvements in secondary outcomes (e.g., patient self-reported PTSD and comorbid symptom severity, relationship satisfaction), one month after treatment and at 3-month follow-up?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AM-CBCT for PTSD | Experimental | Behavioral: Accelerated, Multi-Couple Group CBCT for PTSDAccelerated, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy delivered in a single weekend retreat |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Married or cohabitating couples who have been together the past 3 months in which one partner is a Service Member or recently discharged Veterans eligible for treatment at Carl R. Darnall Army Medical Center (CRDAMC) with PTSD who has deployed since 9/11, seeking treatment for PTSD.
- Diagnosis of PTSD as determined by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and a CAPS-5 score > 25. The Service Member or Veteran with PTSD must have experienced a Criterion A event that is a specific combat-related event or high magnitude operational experience that occurred during a military deployment in support of combat operations following 9/11. The diagnosis of PTSD may be indexed to that event or to another Criterion A event.
- Both individuals must be able to speak and read English.
Key exclusion criteria (8 listed)
- Couple is separated and/or has taken steps to dissolve their relationship (e.g., divorce)
- Currently participating in evidence-based treatment for PTSD (Prolonged Exposure, Cognitive Processing Therapy, or Cognitive-Behavioral Conjoint Therapy for PTSD).
- Recent manic episode (past 12 months) or a psychotic disorder (as determined by the Mania and Psychosis modules of the MINI)
- Current alcohol dependence (as determined by an a score of ≥ 4 on items #4-6 and a total score of ≥20 on the AUDIT)
- Evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires)
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 |
|---|---|---|
| Accelerated, Multi-Couple Group CBCT for PTSDAlso: AM-CBCT for PTSDIntensive weekend retreat version of cognitive-behavioral conjoint therapy for PTSD (Monson \& Fredman, 2012) | Behavioural | AM-CBCT for PTSD |
Primary outcome
Clinician Administered PTSD Scale (CAPS-5)
Time frame: change in PTSD symptoms at 1 and 3 months posttreatment
semi-structured clinician interview to determine presence and severity of PTSD symptoms
3 secondary outcomes
PTSD Checklist for DSM-5 (PCL-5)
Time frame: change in PTSD symptoms at 1 and 3 months posttreatment
Patient Health Questionnaire-9 (PHQ-9)
Time frame: change in PTSD symptoms at 1 and 3 months posttreatment
Couples Satisfaction Index (CSI)
Time frame: change in relationship satisfaction at 1 and 3 months posttreatment
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 19 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Steffany J. Fredman, Ph.D. principal investigator
The Pennsylvania State 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 Accelerated, Multi-Couple Group CBCT for PTSD in people with PTSD, run by Penn State University at 1 site in United States.
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 3 inclusion and 8 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 19 Dec 2018. 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 United States. 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?
Clinician Administered PTSD Scale (CAPS-5) (time frame: change in PTSD symptoms at 1 and 3 months posttreatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2018.