Cognitive-Behavioral Conjoint Therapy (CBCT) Project

Post Traumatic Stress Disorder Clinical Trial

— CBCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02720016
• Other study ID #: D2093-R
• Secondary ID: H150181
• Status: Completed
• Phase: N/A
• Start date: October 3, 2016
• Est. completion date: March 31, 2021

Study information

• Verified date: December 2021
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: March 31, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• 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).
• 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.
• 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.

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	Baseline
Secondary	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.	Mid Treatment (Approximately week 5 of all treatment conditions)
Secondary	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.	1 Month Post Treatment
Secondary	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.	3- Months Post Treatment
Secondary	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.	6-Months Post Treatment
Secondary	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.	Baseline
Secondary	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.	Mid Treatment (Approximately Week 5 of all treatment conditions)
Secondary	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.	1 Month Post Treatment
Secondary	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.	3- Months Post Treatment
Secondary	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.	6-Months Post Treatment
Secondary	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.	Baseline
Secondary	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.	Mid Treatment (Approximately week 5 of all treatment conditions)
Secondary	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.	1 Month Post Treatment
Secondary	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.	3- Months Post Treatment
Secondary	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.	6-Months Post Treatment
Secondary	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.	Baseline
Secondary	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.	Mid Treatment (Approximately week 5 of all treatment conditions)
Secondary	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.	1 Month Post Treatment
Secondary	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.	3- Months Post Treatment
Secondary	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.	6-Months Post Treatment