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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01035788
First received: December 17, 2009
Last updated: August 31, 2016
Last verified: August 2016
Results First Received: September 23, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: PTSD
Interventions: Behavioral: Mindfulness Based Cognitive Behavioral Conjoint Therapy
Behavioral: CBCT for PTSD - Communication Skills

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
88 couples (88 Veterans & their 88 intimate partners) were consented & 78 couples completed eligibility screening. 32 couples were excluded (not meeting inclusion/exclusion criteria; met criteria but declined to proceed, or unable to attend required retreat weekend. The remaining 46 couples were randomized (46 Veterans & 46 partners).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Mindfulness-Based Cognitive-Behavioral Conjoint Therapy Mindfulness-Based Cognitive-Behavioral Conjoint Therapy for PTSD (MB-CBCT) is an adaptation of Cognitive-Behavioral Conjoint Therapy for PTSD (CBCT) that offers CBCT Phases 1 and 2 plus mindfulness training in a couple weekend retreat format, followed by continued use of mindfulness skills in session and for out of session practice during one transition couple therapy session, followed by CBCT Phase 3 couple sessions.
Cognitive Behavioral Conjoint Therapy Communication Skills Cognitive-Behavioral Conjoint Therapy (CBCT) phases 1-2 communications skills training (no PTSD psychoeducation) offered during a weekend couple retreat followed by two monthly group couple sessions for skills review.

Participant Flow:   Overall Study
    Mindfulness-Based Cognitive-Behavioral Conjoint Therapy   Cognitive Behavioral Conjoint Therapy Communication Skills
STARTED   23 [1]   23 [1] 
COMPLETED   17   9 
NOT COMPLETED   6   14 
[1] 23 couples = 23 Veterans + 23 partners; only data for Veterans will be included for primary outcome.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Data is included for Veterans only since this was the data needed for the primary outcome analysis of the Clinician Administered PTSD Scale for the Veteran participants who had PTSD.

Reporting Groups
  Description
Mindfulness-Based Cognitive-Behavioral Conjoint Therapy

Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD

Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD: This intervention combines cognitive behavioral conjoint therapy for PTSD and mindfulness skills. Cognitive behavioral conjoint therapy for PTSD includes psychoeducation, 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.

Cognitive Behavioral Conjoint Therapy Communication Skills

Psychoeducational Intervention

Psychoeducation (control): This control intervention will provide psychoeducation including the communication content from sessions 1-7 of cognitive behavioral conjoint therapy for PTSD.

Total Total of all reporting groups

Baseline Measures
   Mindfulness-Based Cognitive-Behavioral Conjoint Therapy   Cognitive Behavioral Conjoint Therapy Communication Skills   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   23   46 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.9  (9.2)   41.0  (11.3)   39.9  (10.3) 
Gender 
[Units: Participants]
     
Female   1   4   5 
Male   22   19   41 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   0   3   3 
White   21   19   40 
More than one race   0   0   0 
Unknown or Not Reported   2   1   3 
Clinician Administered PTSD Scale (CAPS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 71.1  (12.4)   70.4  (13.9)   70.7  (13.1) 
[1] The Clinician Administered PTSD Scale (CAPS) 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.
PTSD Checklist (PCL) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 57.6  (7.8)   57.2  (10.5)   57.4  (9.2) 
[1] The PTSD Checklist (PCL) is a 17-item self-report measure of PTSD symptom severity corresponding to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (APA, 2000) PTSD symptoms. The score range is 17-85 and higher scores indicated greater PTSD symptoms severity.
Dyadic Adjustment Scale (DAS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 99.7  (19.2)   96.0  (25.0)   97.9  (22.1) 
[1] The Dyadic Adjustment Scale (DAS) is a 32-item self-report inventory designed to measure partner perceptions of the quality of an intimate dyadic relationship. Scores range from 0-151, with higher scores indicating higher satisfaction. A total score of 98 or higher indicates relationship satisfaction.
Beck Depression Inventory II (BDI) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 25.6  (9.5)   26.8  (9.6)   26.2  (9.5) 
[1] The Beck Depression Inventory (BDI) is a 21 item self-report measure of symptoms of depression over the course of the past two weeks. Items are rated on a 4-point scale ranging from zero to three. Ratings for each item are summed yielding total scores between zero and 63. Higher scores indicate higher levels of depressive symptoms.
State-Trait Anxiety Inventory State Subscale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 51.9  (8.3)   49.8  (12.7)   50.9  (10.7) 
[1] The State subscale of the State-Trait Anxiety Inventory (STAI) is a self-report measure of current anxiety symptoms. The scores range 20-80 and higher scores indicate higher levels of current anxiety.


  Outcome Measures

1.  Primary:   Clinician-Administered PTSD Scale (CAPS)   [ Time Frame: treatment end (approximately 10 weeks after session 1 of the interventions) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Louanne Davis
Organization: Department of Veterans Affairs
phone: 317-988-4523
e-mail: louanne.davis@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01035788     History of Changes
Other Study ID Numbers: B7331-R
1001-02B ( Other Identifier: IUPUI IRB )
Study First Received: December 17, 2009
Results First Received: September 23, 2015
Last Updated: August 31, 2016
Health Authority: United States: Federal Government