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Cognitive-Behavioral Conjoint Therapy (CBCT) Project (CBCT)

Primary Purpose

Post Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBCT-Home Based (CBCT-HB)
CBCT-Office Based (CBCT-OB)
PTSD Family Education (PFE)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring Post Traumatic Stress Disorder, Marital Therapy, Veterans, Telemedicine, Couples

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA San Diego Healthcare System, San Diego, CA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

CBCT-Home Based (CBCT-HB)

CBCT-Office Based (CBCT-OB)

PTSD Family Education (PFE)

Arm Description

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).

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.

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.

Outcomes

Primary Outcome Measures

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
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

PTSD Checklist-5 (PCL-5)
The PCL-5 is a 20 item self report questionnaire assessing symptoms of PTSD based on DSM-V criteria. Scores range from 0 to 80, with higher scores representing more severe symptoms.
PTSD Checklist-5 (PCL-5)
The PCL-5 is a 20 item self report questionnaire assessing symptoms of PTSD based on DSM-V criteria. Scores range from 0 to 80, with higher scores representing more severe symptoms.
PTSD Checklist-5 (PCL-5)
The PCL-5 is a 20 item self report questionnaire assessing symptoms of PTSD based on DSM-V criteria. Scores range from 0 to 80, with higher scores representing more severe symptoms.
PTSD Checklist-5 (PCL-5)
The PCL-5 is a 20 item self report questionnaire assessing symptoms of PTSD based on DSM-V criteria. Scores range from 0 to 80, with higher scores representing more severe symptoms.
PTSD Checklist-5 (PCL-5)
The PCL-5 is a 20 item self report questionnaire assessing symptoms of PTSD based on DSM-V criteria. Scores range from 0 to 80, with higher scores representing more severe symptoms.
Beck Depression Inventory-II (BDI-2)
The BDI is a 21-item self report questionnaire assessing symptoms of depression. Scores range from 0 to 63, with higher scores representing more severe symptoms.
Beck Depression Inventory-II (BDI-2)
The BDI is a 21-item self report questionnaire assessing symptoms of depression. Scores range from 0 to 63, with higher scores representing more severe symptoms.
Beck Depression Inventory-II (BDI-2)
The BDI is a 21-item self report questionnaire assessing symptoms of depression. Scores range from 0 to 63, with higher scores representing more severe symptoms.
Beck Depression Inventory-II (BDI-2)
The BDI is a 21-item self report questionnaire assessing symptoms of depression. Scores range from 0 to 63, with higher scores representing more severe symptoms.
Beck Depression Inventory-II (BDI-2)
The BDI is a 21-item self report questionnaire assessing symptoms of depression. Scores range from 0 to 63, with higher scores representing more severe symptoms.
State-Trait Anger Inventory (STAXI)
The STAXI-2 is a self-report questionnaire assessing state and trait anger. The State subscale (15 items) ranges from 15 to 60, and the Trait subscale (10 items) ranges from 10 to 40, with higher scores representing more anger.
State-Trait Anger Inventory (STAXI)
The STAXI-2 is a self-report questionnaire assessing state and trait anger. The State subscale (15 items) ranges from 15 to 60, and the Trait subscale (10 items) ranges from 10 to 40, with higher scores representing more anger.
State-Trait Anger Inventory (STAXI)
The STAXI-2 is a self-report questionnaire assessing state and trait anger. The State subscale (15 items) ranges from 15 to 60, and the Trait subscale (10 items) ranges from 10 to 40, with higher scores representing more anger.
State-Trait Anger Inventory (STAXI)
The STAXI-2 is a self-report questionnaire assessing state and trait anger. The State subscale (15 items) ranges from 15 to 60, and the Trait subscale (10 items) ranges from 10 to 40, with higher scores representing more anger.
State-Trait Anger Inventory (STAXI)
The STAXI-2 is a self-report questionnaire assessing state and trait anger. The State subscale (15 items) ranges from 15 to 60, and the Trait subscale (10 items) ranges from 10 to 40, with higher scores representing more anger.
Conflict Tactics Scale Short Form- (CTS-2S)
20-item self-report inventory yielding 5 scales. Most widely used measure of its kind. Scores on the Psychological Aggression and Negotiation subscales range from 0 to 24, with higher scores representing more Psychological Aggression and more Negotiation.
Conflict Tactics Scale Short Form- (CTS-2S)
20-item self-report inventory yielding 5 scales. Most widely used measure of its kind. Scores on the Psychological Aggression and Negotiation subscales range from 0 to 24, with higher scores representing more Psychological Aggression and more Negotiation.
Conflict Tactics Scale Short Form- (CTS-2S)
20-item self-report inventory yielding 5 scales. Most widely used measure of its kind. Scores on the Psychological Aggression and Negotiation subscales range from 0 to 24, with higher scores representing more Psychological Aggression and more Negotiation.
Conflict Tactics Scale Short Form- (CTS-2S)
20-item self-report inventory yielding 5 scales. Most widely used measure of its kind. Scores on the Psychological Aggression and Negotiation subscales range from 0 to 24, with higher scores representing more Psychological Aggression and more Negotiation.
Conflict Tactics Scale Short Form- (CTS-2S)
20-item self-report inventory yielding 5 scales. Most widely used measure of its kind. Scores on the Psychological Aggression and Negotiation subscales range from 0 to 24, with higher scores representing more Psychological Aggression and more Negotiation.

Full Information

First Posted
March 7, 2016
Last Updated
December 15, 2021
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02720016
Brief Title
Cognitive-Behavioral Conjoint Therapy (CBCT) Project
Acronym
CBCT
Official Title
An Integrative Technology Approach to Home-based Conjoint Therapy for PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 3, 2016 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
Post Traumatic Stress Disorder, Marital Therapy, Veterans, Telemedicine, Couples

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Study assessors are kept blind to the couple's randomly assigned treatment condition.
Allocation
Randomized
Enrollment
274 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBCT-Home Based (CBCT-HB)
Arm Type
Experimental
Arm Description
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).
Arm Title
CBCT-Office Based (CBCT-OB)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
PTSD Family Education (PFE)
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
CBCT-Home Based (CBCT-HB)
Intervention Description
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
Intervention Name(s)
CBCT-Office Based (CBCT-OB)
Intervention Description
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
Intervention Name(s)
PTSD Family Education (PFE)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale (CAPS)
Description
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
Time Frame
Baseline
Title
Clinician Administered PTSD Scale (CAPS)
Description
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
Time Frame
1 Month Post Treatment
Title
Clinician Administered PTSD Scale (CAPS)
Description
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
Time Frame
3-Months Post Treatment
Title
Clinician Administered PTSD Scale (CAPS)
Description
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
Time Frame
6- Months Post Treatment
Title
Couples Satisfaction Index (CSI)
Description
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.
Time Frame
Baseline
Title
Couples Satisfaction Index (CSI)
Description
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.
Time Frame
Mid Treatment (Approximately week 5 of all treatment conditions)
Title
Couples Satisfaction Index (CSI)
Description
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.
Time Frame
1 Month Post Treatment
Title
Couples Satisfaction Index (CSI)
Description
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.
Time Frame
3- Months Post Treatment
Title
Couples Satisfaction Index (CSI)
Description
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.
Time Frame
6- Months Post Treatment
Title
Inventory of Psychosocial Functioning (IPF)
Description
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.
Time Frame
Baseline
Title
Inventory of Psychosocial Functioning (IPF)
Description
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.
Time Frame
Mid Treatment (Approximately week 5 of all treatment conditions)
Title
Inventory of Psychosocial Functioning (IPF)
Description
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.
Time Frame
1 Month Post Treatment
Title
Inventory of Psychosocial Functioning (IPF)
Description
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.
Time Frame
3- Months Post Treatment
Title
Inventory of Psychosocial Functioning (IPF)
Description
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.
Time Frame
6- Months Post Treatment
Title
Client Satisfaction Questionnaire (CSQ)
Description
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.
Time Frame
1 Month Post Treatment
Title
Working Alliance Inventory- Short Form (WAI-S)
Description
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.
Time Frame
Approximately week 3 of all treatment conditions
Title
Working Alliance Inventory- Short Form (WAI-S)
Description
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.
Time Frame
Approximately week 8 of all treatment conditions
Secondary Outcome Measure Information:
Title
PTSD Checklist-5 (PCL-5)
Description
The PCL-5 is a 20 item self report questionnaire assessing symptoms of PTSD based on DSM-V criteria. Scores range from 0 to 80, with higher scores representing more severe symptoms.
Time Frame
Baseline
Title
PTSD Checklist-5 (PCL-5)
Description
The PCL-5 is a 20 item self report questionnaire assessing symptoms of PTSD based on DSM-V criteria. Scores range from 0 to 80, with higher scores representing more severe symptoms.
Time Frame
Mid Treatment (Approximately week 5 of all treatment conditions)
Title
PTSD Checklist-5 (PCL-5)
Description
The PCL-5 is a 20 item self report questionnaire assessing symptoms of PTSD based on DSM-V criteria. Scores range from 0 to 80, with higher scores representing more severe symptoms.
Time Frame
1 Month Post Treatment
Title
PTSD Checklist-5 (PCL-5)
Description
The PCL-5 is a 20 item self report questionnaire assessing symptoms of PTSD based on DSM-V criteria. Scores range from 0 to 80, with higher scores representing more severe symptoms.
Time Frame
3- Months Post Treatment
Title
PTSD Checklist-5 (PCL-5)
Description
The PCL-5 is a 20 item self report questionnaire assessing symptoms of PTSD based on DSM-V criteria. Scores range from 0 to 80, with higher scores representing more severe symptoms.
Time Frame
6-Months Post Treatment
Title
Beck Depression Inventory-II (BDI-2)
Description
The BDI is a 21-item self report questionnaire assessing symptoms of depression. Scores range from 0 to 63, with higher scores representing more severe symptoms.
Time Frame
Baseline
Title
Beck Depression Inventory-II (BDI-2)
Description
The BDI is a 21-item self report questionnaire assessing symptoms of depression. Scores range from 0 to 63, with higher scores representing more severe symptoms.
Time Frame
Mid Treatment (Approximately Week 5 of all treatment conditions)
Title
Beck Depression Inventory-II (BDI-2)
Description
The BDI is a 21-item self report questionnaire assessing symptoms of depression. Scores range from 0 to 63, with higher scores representing more severe symptoms.
Time Frame
1 Month Post Treatment
Title
Beck Depression Inventory-II (BDI-2)
Description
The BDI is a 21-item self report questionnaire assessing symptoms of depression. Scores range from 0 to 63, with higher scores representing more severe symptoms.
Time Frame
3- Months Post Treatment
Title
Beck Depression Inventory-II (BDI-2)
Description
The BDI is a 21-item self report questionnaire assessing symptoms of depression. Scores range from 0 to 63, with higher scores representing more severe symptoms.
Time Frame
6-Months Post Treatment
Title
State-Trait Anger Inventory (STAXI)
Description
The STAXI-2 is a self-report questionnaire assessing state and trait anger. The State subscale (15 items) ranges from 15 to 60, and the Trait subscale (10 items) ranges from 10 to 40, with higher scores representing more anger.
Time Frame
Baseline
Title
State-Trait Anger Inventory (STAXI)
Description
The STAXI-2 is a self-report questionnaire assessing state and trait anger. The State subscale (15 items) ranges from 15 to 60, and the Trait subscale (10 items) ranges from 10 to 40, with higher scores representing more anger.
Time Frame
Mid Treatment (Approximately week 5 of all treatment conditions)
Title
State-Trait Anger Inventory (STAXI)
Description
The STAXI-2 is a self-report questionnaire assessing state and trait anger. The State subscale (15 items) ranges from 15 to 60, and the Trait subscale (10 items) ranges from 10 to 40, with higher scores representing more anger.
Time Frame
1 Month Post Treatment
Title
State-Trait Anger Inventory (STAXI)
Description
The STAXI-2 is a self-report questionnaire assessing state and trait anger. The State subscale (15 items) ranges from 15 to 60, and the Trait subscale (10 items) ranges from 10 to 40, with higher scores representing more anger.
Time Frame
3- Months Post Treatment
Title
State-Trait Anger Inventory (STAXI)
Description
The STAXI-2 is a self-report questionnaire assessing state and trait anger. The State subscale (15 items) ranges from 15 to 60, and the Trait subscale (10 items) ranges from 10 to 40, with higher scores representing more anger.
Time Frame
6-Months Post Treatment
Title
Conflict Tactics Scale Short Form- (CTS-2S)
Description
20-item self-report inventory yielding 5 scales. Most widely used measure of its kind. Scores on the Psychological Aggression and Negotiation subscales range from 0 to 24, with higher scores representing more Psychological Aggression and more Negotiation.
Time Frame
Baseline
Title
Conflict Tactics Scale Short Form- (CTS-2S)
Description
20-item self-report inventory yielding 5 scales. Most widely used measure of its kind. Scores on the Psychological Aggression and Negotiation subscales range from 0 to 24, with higher scores representing more Psychological Aggression and more Negotiation.
Time Frame
Mid Treatment (Approximately week 5 of all treatment conditions)
Title
Conflict Tactics Scale Short Form- (CTS-2S)
Description
20-item self-report inventory yielding 5 scales. Most widely used measure of its kind. Scores on the Psychological Aggression and Negotiation subscales range from 0 to 24, with higher scores representing more Psychological Aggression and more Negotiation.
Time Frame
1 Month Post Treatment
Title
Conflict Tactics Scale Short Form- (CTS-2S)
Description
20-item self-report inventory yielding 5 scales. Most widely used measure of its kind. Scores on the Psychological Aggression and Negotiation subscales range from 0 to 24, with higher scores representing more Psychological Aggression and more Negotiation.
Time Frame
3- Months Post Treatment
Title
Conflict Tactics Scale Short Form- (CTS-2S)
Description
20-item self-report inventory yielding 5 scales. Most widely used measure of its kind. Scores on the Psychological Aggression and Negotiation subscales range from 0 to 24, with higher scores representing more Psychological Aggression and more Negotiation.
Time Frame
6-Months Post Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie A. Morland, PsyD
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35604746
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.
Results Reference
derived
PubMed Identifier
35084882
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.
Results Reference
derived

Learn more about this trial

Cognitive-Behavioral Conjoint Therapy (CBCT) Project

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