Cognitive-Behavioral Conjoint Therapy (CBCT) Project

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-03

Study Completion Date

2021-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Individual PE vs Couples' CBT for Combat-Related Posttraumatic Stress Disorder

NCT02336971

PTSD Marital Relationship

COMPLETED PHASE3

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

NCT01035788

PTSD

COMPLETED NA

Effectiveness of Cognitive Behavioral Couples Therapy for Post-traumatic Stress Disorder

NCT00669981

Post-traumatic Stress Disorder

COMPLETED PHASE2/PHASE3

Cognitive Training for PTSD

NCT03316196

Posttraumatic Stress Disorder

COMPLETED NA

Integrated Treatment for Chronic Pain and Posttraumatic Stress Disorder (PTSD)

NCT00127413

Pain Posttraumatic Stress Disorder

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post Traumatic Stress Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study assessors are kept blind to the couple's randomly assigned treatment condition.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CBCT-Home Based (CBCT-HB)

Couples in CBCT-HB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks to the Veterans home via home-based clinical video teleconferencing (CVT).

Group Type EXPERIMENTAL

CBCT-Home Based (CBCT-HB)

Intervention Type BEHAVIORAL

Couples in CBCT-HB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks to the Veterans home via home-based clinical video teleconferencing (CVT).

CBCT-Office Based (CBCT-OB)

Couples in CBCT-OB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks in-person in the therapist's office.

Group Type ACTIVE_COMPARATOR

CBCT-Office Based (CBCT-OB)

Intervention Type BEHAVIORAL

Couples in CBCT-OB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks in-person in the therapist's office.

PTSD Family Education (PFE)

Couples in the PFE condition will receive 8 sessions of standardized PTSD Family Education, a manualized psychoeducational program designed to help couples learn more about posttraumatic stress disorder and related difficulties. This psychotherapy is administered over 8 to 15 weeks and is delivered in-person in the therapist's office.

Group Type ACTIVE_COMPARATOR

PTSD Family Education (PFE)

Intervention Type BEHAVIORAL

Couples in the PFE condition will receive 8 sessions of standardized PTSD Family Education, a manualized psychoeducational program designed to help couples learn more about posttraumatic stress disorder and related difficulties. This psychotherapy is administered over 8 to 15 weeks and is delivered in-person in the therapist's office.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CBCT-Home Based (CBCT-HB)

Couples in CBCT-HB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks to the Veterans home via home-based clinical video teleconferencing (CVT).

Intervention Type BEHAVIORAL

CBCT-Office Based (CBCT-OB)

Couples in CBCT-OB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks in-person in the therapist's office.

Intervention Type BEHAVIORAL

PTSD Family Education (PFE)

Couples in the PFE condition will receive 8 sessions of standardized PTSD Family Education, a manualized psychoeducational program designed to help couples learn more about posttraumatic stress disorder and related difficulties. This psychotherapy is administered over 8 to 15 weeks and is delivered in-person in the therapist's office.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Be a Veteran (age 18 or older) with a current Diagnostic and Statistical Manual-5 (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 Digital Subscriber Line (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 Conflict Tactics Scale-2 \[CTS-2\]).

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No