Clinical trial NCT02720016: Cognitive-Behavioral Conjoint Therapy (CBCT) Project
Official title: An Integrative Technology Approach to Home-based Conjoint Therapy for PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: Post Traumatic Stress Disorder
Marital Therapy
Veterans
Telemedicine
Couples
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-03-25
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinician Administered PTSD Scale (CAPS)
timeFrame: Baseline
measure: Clinician Administered PTSD Scale (CAPS)
timeFrame: 1 Month Post Treatment
measure: Clinician Administered PTSD Scale (CAPS)
timeFrame: 3-Months Post Treatment
measure: Clinician Administered PTSD Scale (CAPS)
timeFrame: 6- Months Post Treatment
measure: Couples Satisfaction Index (CSI)
timeFrame: Baseline
measure: Couples Satisfaction Index (CSI)
timeFrame: Mid Treatment (Approximately week 5 of all treatment conditions)
measure: Couples Satisfaction Index (CSI)
timeFrame: 1 Month Post Treatment
measure: Couples Satisfaction Index (CSI)
timeFrame: 3- Months Post Treatment
measure: Couples Satisfaction Index (CSI)
timeFrame: 6- Months Post Treatment
measure: Inventory of Psychosocial Functioning (IPF)
timeFrame: Baseline
measure: Inventory of Psychosocial Functioning (IPF)
timeFrame: Mid Treatment (Approximately week 5 of all treatment conditions)
measure: Inventory of Psychosocial Functioning (IPF)
timeFrame: 1 Month Post Treatment
measure: Inventory of Psychosocial Functioning (IPF)
timeFrame: 3- Months Post Treatment
measure: Inventory of Psychosocial Functioning (IPF)
timeFrame: 6- Months Post Treatment
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 1 Month Post Treatment
measure: Working Alliance Inventory- Short Form (WAI-S)
timeFrame: Approximately week 3 of all treatment conditions
measure: Working Alliance Inventory- Short Form (WAI-S)
timeFrame: Approximately week 8 of all treatment conditions
Secondary outcomes:
measure: PTSD Checklist-5 (PCL-5)
timeFrame: Baseline
measure: PTSD Checklist-5 (PCL-5)
timeFrame: Mid Treatment (Approximately week 5 of all treatment conditions)
measure: PTSD Checklist-5 (PCL-5)
timeFrame: 1 Month Post Treatment
measure: PTSD Checklist-5 (PCL-5)
timeFrame: 3- Months Post Treatment
measure: PTSD Checklist-5 (PCL-5)
timeFrame: 6-Months Post Treatment
measure: Beck Depression Inventory-II (BDI-2)
timeFrame: Baseline
measure: Beck Depression Inventory-II (BDI-2)
timeFrame: Mid Treatment (Approximately Week 5 of all treatment conditions)
measure: Beck Depression Inventory-II (BDI-2)
timeFrame: 1 Month Post Treatment
measure: Beck Depression Inventory-II (BDI-2)
timeFrame: 3- Months Post Treatment
measure: Beck Depression Inventory-II (BDI-2)
timeFrame: 6-Months Post Treatment
measure: State-Trait Anger Inventory (STAXI)
timeFrame: Baseline
measure: State-Trait Anger Inventory (STAXI)
timeFrame: Mid Treatment (Approximately week 5 of all treatment conditions)
measure: State-Trait Anger Inventory (STAXI)
timeFrame: 1 Month Post Treatment
measure: State-Trait Anger Inventory (STAXI)
timeFrame: 3- Months Post Treatment
measure: State-Trait Anger Inventory (STAXI)
timeFrame: 6-Months Post Treatment
measure: Conflict Tactics Scale Short Form- (CTS-2S)
timeFrame: Baseline
measure: Conflict Tactics Scale Short Form- (CTS-2S)
timeFrame: Mid Treatment (Approximately week 5 of all treatment conditions)
measure: Conflict Tactics Scale Short Form- (CTS-2S)
timeFrame: 1 Month Post Treatment
measure: Conflict Tactics Scale Short Form- (CTS-2S)
timeFrame: 3- Months Post Treatment
measure: Conflict Tactics Scale Short Form- (CTS-2S)
timeFrame: 6-Months Post Treatment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Leslie A. Morland, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morland LA, Knopp KC, Khalifian CE, Macdonald A, Grubbs KM, Mackintosh MA, Becker-Cretu JJ, Sautter FJ, Buzzella BA, Wrape ER, Glassman LH, Webster K, Sohn MJ, Glynn SM, Acierno R, Monson CM. A randomized trial of brief couple therapy for PTSD and relationship satisfaction. J Consult Clin Psychol. 2022 May;90(5):392-404. doi: 10.1037/ccp0000731.
citation: Khalifian CE, Bosch J, Knopp K, Delay C, Sohn MJ, Morland LA. Adverse childhood experiences, mental health, and relationship satisfaction in military couples. J Fam Psychol. 2022 Jun;36(4):630-635. doi: 10.1037/fam0000952. Epub 2022 Jan 27.