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| ID | Type | Description | Link |
|---|---|---|---|
| 1001-02B | Other Identifier | IUPUI IRB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Based CBCT | Experimental | Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD |
|
| CBCT Communication Skills | Active Comparator | CBCT for PTSD - Communication Skills |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Veteran must:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louanne Whitman Davis, PsyD | Richard L. Roudebush VA Medical Center, Indianapolis, IN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richard L. Roudebush VA Medical Center, Indianapolis, IN | Indianapolis | Indiana | 46202-2884 | United States |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This analysis was intention to treat and included the 30 participants of the original 34 who completed the CAPS interview at treatment end. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | treatment end (approximately 10 weeks after session 1 of the interventions) |
|
4 years
Adverse events were assessed for both veterans and their partners separately. There were no adverse events for veterans or their partners.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness-Based Cognitive-Behavioral Conjoint Therapy | Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD Mindfulness Based Cognitive Behavioral Conjoint Therapy: 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Louanne Davis | Department of Veterans Affairs | 317-988-4523 | louanne.davis@va.gov |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| 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. |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Clinician Administered PTSD Scale (CAPS) | 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. | Mean | Standard Deviation | units on a scale |
|
| PTSD Checklist (PCL) | 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. | Mean | Standard Deviation | units on a scale |
|
| Dyadic Adjustment Scale (DAS) | 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. | Mean | Standard Deviation | units on a scale |
|
| Beck Depression Inventory II (BDI) | 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. | Mean | Standard Deviation | units on a scale |
|
| State-Trait Anxiety Inventory State Subscale | 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. | Mean | Standard Deviation | units on a scale |
|
Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD This intervention combines cognitive behavioral conjoint therapy for PTSD and mindfulness skills. Cognitive Behavioral ConjointTtherapy 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. |
| OG001 | Cognitive Behavioral Conjoint Therapy Communication Skills | Cognitive-Behavioral Conjoint Therapy for PTSD - Communication Skills This control intervention will provide communication skills training from sessions 1-7 of Cognitive Behavioral Conjoint Therapy for PTSD. |
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| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Cognitive Behavioral Conjoint Therapy Communication Skills | CBCT for PTSD - Communication Skills CBCT for PTSD - Communication Skills: This control intervention will provide psychoeducation including the communication skills content from sessions 1-7 of Cognitive Behavioral Conjoint Therapy for PTSD. | 0 | 46 | 0 | 46 |
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