Cognitive-Behavioral Conjoint Therapy (CBCT) Project



Status:Recruiting
Conditions:Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:11/8/2018
Start Date:October 3, 2016
End Date:March 31, 2020
Contact:Daniel A Barlam, MA
Email:daniel.barlam@va.gov
Phone:(858) 552-8585

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An Integrative Technology Approach to Home-based Conjoint Therapy for PTSD

Untreated posttraumatic stress disorder (PTSD) is a costly condition associated with
impairment in functioning across a host of psychosocial domains including occupational and
academic functioning, marital and family functioning, parenting, and socialization.
Impairment is not limited to Veterans with PTSD because the entire family is affected,
particularly the Veteran's intimate partner. PTSD symptoms can produce negative effects on
both members of the dyad. Despite the need for treatment, many Veterans and their families do
not access PTSD-related services due to a number of barriers to accessing care (e.g., living
in rural or remote areas where no specialty services exist, concerns about stigma around
using mental health services, limited clinic hours to accommodate patient schedules). The
objective of this study is to assess whether providing Cognitive-Behavioral Conjoint Therapy,
in which PTSD symptoms and intimate relationship functioning are addressed, to Veterans and
their romantic partners in their homes via clinical video teleconferencing leads to better
outcomes compared to office based treatment.

Anticipated Impact on Veterans' Healthcare: This project addresses the mental health and
functioning needs of Veterans and their families by increasing the access to an established
treatment using telemental health technology.

Project Background: Veterans and their families experience the deleterious effects of
posttraumatic stress disorder (PTSD) and associated negative sequelae. PTSD is related to a
variety of comorbid mental health symptomatology and psychosocial impairment, including high
rates of intimate relationship problems which impact Veterans' recovery and functioning.
Despite available couple-based interventions, barriers to care such as stigma regarding
mental health treatment, travel time to receive care, and transportation costs, make it
difficult for Veterans and their families to access specialty PTSD treatments necessary for
rehabilitation. Home-based clinical video teleconferencing (CVT) delivers specialized mental
health treatments to clients in the ease of their own home, which allows clinicians to
directly observe the client's home environment and family milieu. Cognitive-Behavioral
Conjoint Therapy (CBCT), a couple-based treatment designed to target PTSD symptoms and
improve individual and relationship functioning, has shown evidence of improvements in
clinical symptom outcomes in research conducted with Veterans and their partners.

Project Objectives: This is a 4-year randomized controlled trial. The primary objective of
this study is to compare the clinical efficacy (PTSD symptoms, relationship distress, and
functional impairment) of CBCT delivered via an office-based (CBCT-OB) or a home-based CVT
(CBCT-HB) delivery modality to the PTSD Family Education control condition (PFE). In
addition, this study will estimate and compare the difference in clinical efficacy between
CBCT delivered via an office-based (CBCT-OB) or a home-based CVT (CBCT-HB) delivery modality
if indicated by results of the primary objective. This study will also compare process
outcomes (therapeutic alliance, enrollment and dropout rates, and treatment satisfaction) for
CBCT-OB, CBCT-HB, and PFE.

Project Methods: Participants will be 180 intent-to-treat couples in which one partner is a
PTSD-positive Veteran. Couples will be randomly assigned to receive treatment through one of
the three treatment delivery modalities: CBCT-OB, CBCT-HB or PFE. Assessments will be
conducted at baseline, mid- and post-treatment, and 3- and 6-months post-treatment. The
primary outcome variables of clinical efficacy will be measures of PTSD symptom severity,
relationship distress, and functional impairment. Secondary outcome variables include PTSD
diagnostic status, self- reported PTSD symptoms, depression, anger, and relationship
conflict. Additionally, primary process outcomes will include measures of treatment
retention, attendance, therapeutic alliance, and treatment satisfaction. Variability in
scores for each of the primary and secondary outcome measures will be examined individually
in a series of separate multilevel models. The results will provide evidence that can be used
to further increase the clinical efficacy, ease of access to, and utilization of specialty
PTSD treatment to Veterans and their families.

Inclusion Criteria:

- Be a Veteran (age 18 or older) with a current DSM-5 diagnosis of PTSD (as assessed by
the CAPS) no less than 3 months after the index trauma occurred (to allow for
potential natural recovery)

- Be on a stable psychoactive medication regimen for at least 2 months (if eligible)

- Be an intimate partner (age 18 or older) who is willing to participate in the
intervention.

- Be randomized into any of the three treatment conditions

- Have assessment and treatment sessions audio recorded

- Agree not to receive other individual or conjoint psychotherapy for PTSD during the
treatment portion of the study

- Consistent with home-based clinical trials and actual clinical practice

- Participants enrolled into the study will need to have access to internet via DSL or a
cable provider in case they are randomized into the home-based condition.

- The frequency of occurrence of no internet service will be tracked

- If the PTSD-positive Veteran is currently receiving treatment at the VA, study
staff will consult with their primary clinician prior to their inclusion in the
study

Exclusion Criteria:

- Current substance dependence in either member of the couple not in remission for at
least 3 months, as assessed by the Alcohol Use Disorders Identification Test
(AUDIT)108 and Drug Abuse Screening Test (DAST)

- Any current uncontrolled psychotic disorder in either member of the couple

- Imminent suicidality or homicidality in either member of the couple

- Any severe cognitive impairment in either member of the couple

- Any perpetration of severe physical or sexual relationship aggression in the past year
(as assessed by the CTS-2).

- Participants who do not meet study criteria will be offered referrals to
alternate services, as well as assistance in contacting the referral sites as
needed
We found this trial at
1
site
San Diego, California 92161
Principal Investigator: Leslie A. Morland, PsyD
Phone: 858-552-8585
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mi
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San Diego, CA
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