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

NCT01035788 | Completed Results

• 2 other identifiers: B7331-R1001-02B
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

PTSD

Keywords

PTSD; mindfulness meditation; cognitive behavior therapy; relationship function; couple therapy

Outcome Measures

Primary Outcomes (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.

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

Study Arms (2)

Mindfulness-Based CBCT

EXPERIMENTAL

Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD

Behavioral: Mindfulness Based Cognitive Behavioral Conjoint Therapy

CBCT Communication Skills

ACTIVE COMPARATOR

CBCT for PTSD - Communication Skills

Behavioral: CBCT for PTSD - Communication Skills

Interventions

Mindfulness Based Cognitive Behavioral Conjoint Therapy BEHAVIORAL

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.

Mindfulness-Based CBCT

CBCT for PTSD - Communication Skills BEHAVIORAL

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

CBCT Communication Skills

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Limitations and Caveats

Detecting significant differences between groups may be limited by loss to follow-up of 3x more CBCT-S subjects than MB-CBCT. Differences between CAPS and PCL ratings may suggest issues with CAPS assessors although inter-rater reliability was strong.

Results Point of Contact

• Title: Dr. Louanne Davis
• Organization: Department of Veterans Affairs

louanne.davis@va.gov

317-988-4523

Study Officials

• Louanne Whitman Davis, PsyD

  Richard L. Roudebush VA Medical Center, Indianapolis, IN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: December 21, 2009
• Study Start: July 1, 2010
• Primary Completion: June 30, 2014
• Study Completion: December 31, 2014
• Last Updated: November 1, 2018
• Results First Posted: December 16, 2015

Record last verified: 2018-10

Locations

US (1)