Post Traumatic Stress DisorderCBCTNCT02720016
Cognitive-Behavioral Conjoint Therapy (CBCT) Project
A study testing CBCT-Home Based (CBCT-HB), CBCT-Office Based (CBCT-OB) and PTSD Family Education (PFE) in people with Post Traumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- CBCT-Home Based (CBCT-HB), CBCT-Office Based (CBCT-OB) and PTSD Family Education (PFE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2016to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
About this study
Official title: An Integrative Technology Approach to Home-based Conjoint Therapy for PTSD
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.
Read the 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.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- CBCT-Home Based (CBCT-HB), CBCT-Office Based (CBCT-OB), PTSD Family Education (PFE)
- Keywords
- Post Traumatic Stress Disorder, Marital Therapy, Veterans, Telemedicine, Couples
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCT-Home Based (CBCT-HB)Behavioural
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)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: Behavioral: PTSD Family Education (PFE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately week 8 of all treatment conditions
Secondary outcomes (20)
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.
Measured: Baseline
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.
Measured: Mid Treatment (Approximately week 5 of all treatment conditions)
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.
Measured: 1 Month Post Treatment
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.
Measured: 3- Months Post Treatment
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.
Measured: 6-Months Post Treatment
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.
Measured: Baseline
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.
Measured: Mid Treatment (Approximately Week 5 of all treatment conditions)
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.
Measured: 1 Month Post Treatment
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.
Measured: 3- Months Post Treatment
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.
Measured: 6-Months Post Treatment
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.
Measured: Baseline
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.
Measured: Mid Treatment (Approximately week 5 of all treatment conditions)
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.
Measured: 1 Month Post Treatment
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.
Measured: 3- Months Post Treatment
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.
Measured: 6-Months Post Treatment
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.
Measured: Baseline
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.
Measured: Mid Treatment (Approximately week 5 of all treatment conditions)
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.
Measured: 1 Month Post Treatment
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.
Measured: 3- Months Post Treatment
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.
Measured: 6-Months Post Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study start3 Oct 2016
- Primary completion30 Sep 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Leslie A. Morland, PsyD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720016
- Sponsor's protocol ID
- D2093-R
- Other IDs
- H150181
- Acronym
- CBCT
- Status last verified
- Dec 2021
- First submitted
- 7 Mar 2016
- Last updated
- 7 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35604746Khalifian 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.
PubMed 35084882
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrative Technology Approach to Home-based Conjoint Therapy for PTSD
- ClinicalTrials.gov ID
- NCT02720016
- Acronym / sponsor ID
- CBCT / D2093-R
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Post Traumatic Stress Disorder, Marital Therapy, Veterans, Telemedicine, Couples
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 Oct 2016 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Posted 7 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBCT-Home Based (CBCT-HB) | Experimental | 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) | Active comparator | 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. |
| PTSD Family Education (PFE) | Active comparator | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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]).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | CBCT-Home Based (CBCT-HB) |
| 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. | Behavioural | CBCT-Office Based (CBCT-OB) |
| 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. | Behavioural | PTSD Family Education (PFE) |
Primary outcome
Clinician Administered PTSD Scale (CAPS)
Time frame: Baseline
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)
Time frame: 1 Month Post Treatment
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)
Time frame: 3-Months Post Treatment
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)
Time frame: 6- Months Post Treatment
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)
Time frame: Baseline
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)
Time frame: Mid Treatment (Approximately week 5 of all treatment conditions)
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)
Time frame: 1 Month Post Treatment
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)
Time frame: 3- Months Post Treatment
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)
Time frame: 6- Months Post Treatment
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)
Time frame: Baseline
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)
Time frame: Mid Treatment (Approximately week 5 of all treatment conditions)
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)
Time frame: 1 Month Post Treatment
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)
Time frame: 3- Months Post Treatment
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)
Time frame: 6- Months Post Treatment
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)
Time frame: 1 Month Post Treatment
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)
Time frame: Approximately week 3 of all treatment conditions
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)
Time frame: Approximately week 8 of all treatment conditions
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.
20 secondary outcomes
PTSD Checklist-5 (PCL-5)
Time frame: Baseline
PTSD Checklist-5 (PCL-5)
Time frame: Mid Treatment (Approximately week 5 of all treatment conditions)
PTSD Checklist-5 (PCL-5)
Time frame: 1 Month Post Treatment
PTSD Checklist-5 (PCL-5)
Time frame: 3- Months Post Treatment
PTSD Checklist-5 (PCL-5)
Time frame: 6-Months Post Treatment
Beck Depression Inventory-II (BDI-2)
Time frame: Baseline
Beck Depression Inventory-II (BDI-2)
Time frame: Mid Treatment (Approximately Week 5 of all treatment conditions)
Beck Depression Inventory-II (BDI-2)
Time frame: 1 Month Post Treatment
Beck Depression Inventory-II (BDI-2)
Time frame: 3- Months Post Treatment
Beck Depression Inventory-II (BDI-2)
Time frame: 6-Months Post Treatment
State-Trait Anger Inventory (STAXI)
Time frame: Baseline
State-Trait Anger Inventory (STAXI)
Time frame: Mid Treatment (Approximately week 5 of all treatment conditions)
State-Trait Anger Inventory (STAXI)
Time frame: 1 Month Post Treatment
State-Trait Anger Inventory (STAXI)
Time frame: 3- Months Post Treatment
State-Trait Anger Inventory (STAXI)
Time frame: 6-Months Post Treatment
Conflict Tactics Scale Short Form- (CTS-2S)
Time frame: Baseline
Conflict Tactics Scale Short Form- (CTS-2S)
Time frame: Mid Treatment (Approximately week 5 of all treatment conditions)
Conflict Tactics Scale Short Form- (CTS-2S)
Time frame: 1 Month Post Treatment
Conflict Tactics Scale Short Form- (CTS-2S)
Time frame: 3- Months Post Treatment
Conflict Tactics Scale Short Form- (CTS-2S)
Time frame: 6-Months Post Treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35604746Morland 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.
- Derived from this study: PubMed 35084882Khalifian 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie A. Morland, PsyD principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBCT-Home Based (CBCT-HB), CBCT-Office Based (CBCT-OB) and PTSD Family Education (PFE) in people with Post Traumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PTSD Scale (CAPS) (time frame: Baseline). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02720016, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.