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PTSDNCT01035788

Effects of Mindfulness-Based Cognitive-Behavioral Conjoint Therapy on PTSD and Relationship Function

A study testing Mindfulness Based Cognitive Behavioral Conjoint Therapy and CBCT for PTSD - Communication Skills in people with PTSD, run by VA Office of Research and Development at 1 site in United States.

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

The purpose of this study is to first adapt Cognitive Behavioral Conjoint Therapy for PTSD for Operation Enduring Freedom and Operation Iraqi Freedom (OEF-OIF) Veterans diagnosed with PTSD and their intimate partners by (1) reducing the overall length of treatment from 15 weeks to 10 weeks through the use of a weekend… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
PTSD
What is being tested?
Mindfulness Based Cognitive Behavioral Conjoint Therapy and CBCT for PTSD - Communication Skills
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteUnited States
Study dates
1 Jul 2010to 31 Dec 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Veteran must:
  • be enrolled in outpatient treatment
  • have a confirmed diagnosis of PTSD
  • have no major change in psychiatric medication for at least 1 month
  • have a partner mutually committed to maintaining the relationship for the duration of the intervention
  • willing to forgo initiating psychotherapy for PTSD or other conditions during the study

Who cannot join

  • severe physical or sexual relationship aggression in the past year
  • current suicidal/homicidal intent (Veteran or partner)
  • cognitive impairment that precludes understanding session content (either Veteran or partner)
  • current substance dependence of Veteran or partner
  • uncontrolled psychotic or bipolar disorder in Veteran or partner
  • PTSD diagnosis in the partner
  • self-mutilation or self-injury within the previous 6 months by Veteran or partner
  • unwilling to have therapy or CAPS sessions video or audio recorded

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Richard L. Roudebush VA Medical Center, Indianapolis, IN

    Indianapolis, Indiana, 46202-2884

Other trials in United States

About this study

The purpose of this study is to first adapt Cognitive Behavioral Conjoint Therapy for PTSD for Operation Enduring Freedom and Operation Iraqi Freedom (OEF-OIF) Veterans diagnosed with PTSD and their intimate partners by (1) reducing the overall length of treatment from 15 weeks to 10 weeks through the use of a weekend couple retreat to deliver the first two of three phases of the three-phase protocol; and (2) by integrating mindfulness interventions as a way to mitigate the short, more condensed treatment. Secondly, this study will examine the effects of this adapted Mindfulness-Based Cognitive-Behavioral Conjoint Therapy on PTSD symptoms and intimate relationship functioning.

Read the detailed description

Between 5 and 15 percent of Veterans return from deployment in Iraq and Afghanistan with PTSD and the symptoms adversely affect many aspects of their lives, including intimate relationships. Although research findings consistently suggest that the degree of intimate relationship dysfunction correlates with the severity of Veteran's PTSD symptoms, few couples interventions have been developed and systematically evaluated. Cognitive Behavioral Conjoint Therapy for PTSD (CBCT for PTSD) is an intervention developed to treat both PTSD and relationship dysfunction that has shown promising preliminary results. However, the literature suggests that OEF-OIF Veterans prefer shorter time-limited treatments and CBCT for PTSD requires as many as 15 sessions. CBCT for PTSD lacks specific interventions that train meta-awareness, such as those taught in mindfulness-based stress reduction (MBSR). Mindfulness practices have an emerging evidence base for improving both PTSD and relationship functioning in several important ways. First, practicing mindfulness promotes the relaxation response which counters hyperarousal and results in a calmer approach to difficulties and challenges. Second, avoidance and numbing are countered by mindfully allowing one's experience to be as it is while suspending judgment, which is associated with increased compassion and empathy. Lastly, mindfulness supports a way of being with all life experiences rather than providing techniques just for coping with specific difficulties, which enables individuals to access inner strengths that are already available to them. Just as many physical conditions require more than one rehabilitation approach, there may be a synergy between CBCT for PTSD and mindfulness interventions. Mindfulness skills may assist individuals in tolerating painful emotional reactions to their experiences which may in turn enhance their awareness of associated feelings and thoughts. With enhanced meta-awareness the beliefs that may maintain PTSD symptoms and relationship dysfunction become more amenable to cognitive restructuring. Therefore, the goal of this study is to examine the effects of a Mindfulness-Based adaptation of CBCT for PTSD. The study involves two phases over the course of four years. In Phase 1, mindfulness interventions will be integrated within the Cognitive Behavioral Conjoint Therapy for PTSD treatment manual and the content of the first 7 sessions of CBCT will be adapted to be delivered during a weekend retreat. The integrated intervention, MB-CBCT for PTSD, will be delivered to 10 OIF-OEF Veterans and each of their intimate partners in order to develop and test procedures to train and monitor therapists. During Phase 2, 40 OEF-OIF Veterans and each of their intimate partners will be consented and a randomized controlled trial with be conducted comparing the MB-CBCT for PTSD with a control condition that teaches communication skills drawn from the first 7 sessions of the CBCT manual. We hypothesize that MB-CBCT for PTSD will lead to greater improvement in: 1) Veterans' PTSD symptoms as measured by the Clinician Administered PTSD Scale (primary outcome) and PTSD Checklist (secondary outcome); 2) Veterans' and partners' relationship functioning (secondary outcome); and 3) anxiety and depression symptoms (secondary outcomes). PTSD constitutes a substantial proportion of the burden of illness among Veterans. The longer term goals of this project are to conduct a fully-powered randomized controlled clinical trial of MB-CBCT to determine its effectiveness and to finalize the treatment manual.

Conditions
PTSD
Being tested
Mindfulness Based Cognitive Behavioral Conjoint Therapy, CBCT for PTSD - Communication Skills
Keywords
PTSD, mindfulness meditation, cognitive behavior therapy, relationship function, 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.

  • Mindfulness Based Cognitive Behavioral Conjoint TherapyBehavioural

    This intervention combines Cognitive Behavioral Conjoint Therapy for PTSD and mindfulness skills. Cognitive Behavioral Conjoint Therapy for PTSD includes PTSD psychoeducation, communication skills training and cognitive restructuring. Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses.

  • CBCT for PTSD - Communication SkillsBehavioural

    This control intervention will provide psychoeducation including the communication skills content from sessions 1-7 of Cognitive Behavioral Conjoint Therapy for PTSD.

Study groups in NCT01035788
Study groupRoleWhat they receive
Mindfulness-Based CBCTExperimentalMindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD
Receives: Behavioral: Mindfulness Based Cognitive Behavioral Conjoint Therapy
CBCT Communication SkillsActive comparatorCBCT for PTSD - Communication Skills
Receives: Behavioral: CBCT for PTSD - Communication Skills

What is being measured

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

  1. Clinician-Administered PTSD Scale (CAPS)

    The Clinician Administered PTSD Scale (CAPS; Blake et al., 1995) is a semi-structured interview that evaluates PTSD symptoms and diagnostic status according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (APA, 2000). The intensity and frequency of each symptom is separately on a 5 point Likert scale ranging from zero to four. The total CAPS symptom severity score ranges from 0-136, with higher scores indicating greater PTSD symptoms severity. For the purposes of this study, a score of 45 or greater confirmed a diagnosis of PTSD.

    Measured: treatment end (approximately 10 weeks after session 1 of the interventions)

Timeline

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

  1. First posted21 Dec 2009 (estimated)
  2. Study start1 Jul 2010
  3. Primary completion30 Jun 2014
  4. Study completion31 Dec 2014

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01035788
Sponsor's protocol ID
B7331-R
Other IDs
1001-02B
Status last verified
Oct 2018
First submitted
17 Dec 2009
Last updated
1 Nov 2018
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Based Cognitive Behavioral Conjoint Therapy and CBCT for PTSD - Communication Skills in people with PTSD, run by VA Office of Research and Development 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 6 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 1 Nov 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?

Yes. Results are posted in the registry (first posted 16 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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) (time frame: treatment end (approximately 10 weeks after session 1 of the interventions)). 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 1 Nov 2018.

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