Cognitive-Behavioral Conjoint Therapy (CBCT) Project

NCT02720016 | Completed Results

• 2 other identifiers: D2093-RH150181
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder

Keywords

Post Traumatic Stress Disorder; Marital Therapy; Veterans; Telemedicine; Couples

Outcome Measures

Primary Outcomes (17)

• Clinician Administered PTSD Scale (CAPS)

  The CAPS-5 is a 30-item clinician administered interview designed to diagnose current and lifetime PTSD and to assess PTSD symptom-severity over the past week. The interview assesses 20 DSM-5 PTSD symptoms as well as onset, duration, distress, and functional impact, overall validity, PTSD severity, and presence of dissociation. Prior to assessing symptoms, the clinical interviewer works with the patient to establish an index-trauma and each follow-up question focuses on symptoms as they relate to the index trauma. \*Score range: 0-80 with higher score indicating greater symptom severity

  Baseline

• Clinician Administered PTSD Scale (CAPS)

  The CAPS-5 is a 30-item clinician administered interview designed to diagnose current and lifetime PTSD and to assess PTSD symptom-severity over the past week. The interview assesses 20 DSM-5 PTSD symptoms as well as onset, duration, distress, and functional impact, overall validity, PTSD severity, and presence of dissociation. Prior to assessing symptoms, the clinical interviewer works with the patient to establish an index-trauma and each follow-up question focuses on symptoms as they relate to the index trauma. \*Score range: 0-80 with higher score indicating greater symptom severity

  1 Month Post Treatment

• Clinician Administered PTSD Scale (CAPS)

  The CAPS-5 is a 30-item clinician administered interview designed to diagnose current and lifetime PTSD and to assess PTSD symptom-severity over the past week. The interview assesses 20 DSM-5 PTSD symptoms as well as onset, duration, distress, and functional impact, overall validity, PTSD severity, and presence of dissociation. Prior to assessing symptoms, the clinical interviewer works with the patient to establish an index-trauma and each follow-up question focuses on symptoms as they relate to the index trauma. \*Score range: 0-80 with higher score indicating greater symptom severity

  3-Months Post Treatment

• Clinician Administered PTSD Scale (CAPS)

  The CAPS-5 is a 30-item clinician administered interview designed to diagnose current and lifetime PTSD and to assess PTSD symptom-severity over the past week. The interview assesses 20 DSM-5 PTSD symptoms as well as onset, duration, distress, and functional impact, overall validity, PTSD severity, and presence of dissociation. Prior to assessing symptoms, the clinical interviewer works with the patient to establish an index-trauma and each follow-up question focuses on symptoms as they relate to the index trauma. \*Score range: 0-80 with higher score indicating greater symptom severity

  6- Months Post Treatment

• Couples Satisfaction Index (CSI)

  The Couples Satisfaction Index is a 32-item self-report survey assessing several domains of relationship satisfaction. Higher sum scores (range 0 to 161) represent higher relationship satisfaction.

  Baseline

• Couples Satisfaction Index (CSI)

  The Couples Satisfaction Index is a 32-item self-report survey assessing several domains of relationship satisfaction. Higher sum scores (range 0 to 161) represent higher relationship satisfaction.

  Mid Treatment (Approximately week 5 of all treatment conditions)

• Couples Satisfaction Index (CSI)

  The Couples Satisfaction Index is a 32-item self-report survey assessing several domains of relationship satisfaction. Higher sum scores (range 0 to 161) represent higher relationship satisfaction.

  1 Month Post Treatment

• Couples Satisfaction Index (CSI)

  The Couples Satisfaction Index is a 32-item self-report survey assessing several domains of relationship satisfaction. Higher sum scores (range 0 to 161) represent higher relationship satisfaction.

  3- Months Post Treatment

• Couples Satisfaction Index (CSI)

  The Couples Satisfaction Index is a 32-item self-report survey assessing several domains of relationship satisfaction. Higher sum scores (range 0 to 161) represent higher relationship satisfaction.

  6- Months Post Treatment

• Inventory of Psychosocial Functioning (IPF)

  The Inventory of Psychosocial Functioning (IPF) is an 80-item self-report measure designed to assess multiple dimensions of functional impairment related to psychiatric disturbances. Higher sum scores (range 0 to 100) indicate more functional impairment.

  Baseline

• Inventory of Psychosocial Functioning (IPF)

  The Inventory of Psychosocial Functioning (IPF) is an 80-item self-report measure designed to assess multiple dimensions of functional impairment related to psychiatric disturbances. Higher sum scores (range 0 to 100) indicate more functional impairment.

  Mid Treatment (Approximately week 5 of all treatment conditions)

• Inventory of Psychosocial Functioning (IPF)

  The Inventory of Psychosocial Functioning (IPF) is an 80-item self-report measure designed to assess multiple dimensions of functional impairment related to psychiatric disturbances. Higher sum scores (range 0 to 100) indicate more functional impairment.

  1 Month Post Treatment

• Inventory of Psychosocial Functioning (IPF)

  The Inventory of Psychosocial Functioning (IPF) is an 80-item self-report measure designed to assess multiple dimensions of functional impairment related to psychiatric disturbances. Higher sum scores (range 0 to 100) indicate more functional impairment.

  3- Months Post Treatment

• Inventory of Psychosocial Functioning (IPF)

  The Inventory of Psychosocial Functioning (IPF) is an 80-item self-report measure designed to assess multiple dimensions of functional impairment related to psychiatric disturbances. Higher sum scores (range 0 to 100) indicate more functional impairment.

  6- Months Post Treatment

• Client Satisfaction Questionnaire (CSQ)

  Client Satisfaction Questionnaire (CSQ) is an 8-item measure about satisfaction with treatment rated on a 4-point Likert scale. Higher mean scores (range 0 to 4) represent higher satisfaction with treatment services.

  1 Month Post Treatment

• Working Alliance Inventory- Short Form (WAI-S)

  This adaptation of the Working Alliance Inventory- short form (WAI-S) includes 14 items assessing therapeutic alliance as reported by the patient on a 7-point Likert scale. Higher sum scores (14 to 98) represent higher patient-reported working alliance.

  Approximately week 3 of all treatment conditions

• Working Alliance Inventory- Short Form (WAI-S)

  This adaptation of the Working Alliance Inventory- short form (WAI-S) includes 14 items assessing therapeutic alliance as reported by the patient on a 7-point Likert scale. Higher sum scores (14 to 98) represent higher patient-reported working alliance.

  Approximately week 8 of all treatment conditions

Secondary Outcomes (20)

• PTSD Checklist-5 (PCL-5)

  Baseline

• PTSD Checklist-5 (PCL-5)

  Mid Treatment (Approximately week 5 of all treatment conditions)

• PTSD Checklist-5 (PCL-5)

  1 Month Post Treatment

• PTSD Checklist-5 (PCL-5)

  3- Months Post Treatment

• PTSD Checklist-5 (PCL-5)

  6-Months Post Treatment

Study Arms (3)

CBCT-Home Based (CBCT-HB)

EXPERIMENTAL

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).

Behavioral: CBCT-Home Based (CBCT-HB)

CBCT-Office Based (CBCT-OB)

ACTIVE COMPARATOR

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.

Behavioral: CBCT-Office Based (CBCT-OB)

PTSD Family Education (PFE)

ACTIVE COMPARATOR

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.

Behavioral: PTSD Family Education (PFE)

Interventions

CBCT-Home Based (CBCT-HB) 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-Home Based (CBCT-HB)

CBCT-Office Based (CBCT-OB) 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.

CBCT-Office Based (CBCT-OB)

PTSD Family Education (PFE) 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.

PTSD Family Education (PFE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

Related Publications (2)

• 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.

  PMID: 35604746 DERIVED

• 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.

  PMID: 35084882 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Limitations and Caveats

Study exclusion criteria (e.g., recent aggression, suicidality) may have excluded couples with more severe pathology. All measures except for the CAPS-5 were self-reported measures, introducing potential bias in reporting. This study involved significant administrative support for telehealth procedures; not all VA clinical settings will include these administrative supports, which may reduce generalizability of our results to standard clinical care.

Results Point of Contact

• Title: Dr. Leslie A. Morland
• Organization: VHASDC

Leslie.Morland@va.gov

858-552-4324

Study Officials

• Leslie A. Morland, PsyD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study assessors are kept blind to the couple's randomly assigned treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 25, 2016
• Study Start: October 3, 2016
• Primary Completion: September 30, 2020
• Study Completion: March 31, 2021
• Last Updated: March 7, 2022
• Results First Posted: March 7, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)