Stress Disorders, Post-traumaticNCT04501328
A Randomized Controlled Trial of Coaching Into Care With VA-CRAFT to Promote Veteran Engagement in PTSD Care
A study testing CIC+VA-CRAFT and CIC in people with Stress Disorders, Post-traumatic, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Posttraumatic stress disorder (PTSD) afflicts many war Veterans, but often they are reluctant to seek help despite availability of effective treatments. Family members are key sources of support who can help encourage such Veterans to initiate mental health services. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-traumatic
- What is being tested?
- CIC+VA-CRAFT and CIC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 2 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The target population consists of partners and first-degree family members who are in regular contact with a Veteran from any service era who believe that their Veteran is suffering from significant symptoms of PTSD and in need of mental health care.
- reporting being in an intimate relationship (dating, engaged, or married) with a Veteran or a first degree family member of a Veteran
- reporting that their Veteran is not engaged in mental health care and has not been for the past 6 months
- reporting perceived symptoms of PTSD in their Veteran
- reporting frequent contact with their Veteran (some verbal or face-to-face contact for 36 of the past 90 days)
- having regular access to the Internet and a telephone; and 6) being 18 years of age or older
Who cannot join
- reporting by the potential participant that they are subject to domestic violence and may not feel safe engaging in CIC+VA-CRAFT activities
- we will exclude partners reporting severe intimate partner violence on the brief Conflict Tactics Scale 2 Short Form with their Veteran in the past 6 months
- appropriate referrals for those excluded based on recent intimate partner violence will be provided
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
About this study
Posttraumatic stress disorder (PTSD) afflicts many war Veterans, but often they are reluctant to seek help despite availability of effective treatments. Family members are key sources of support who can help encourage such Veterans to initiate mental health services. Toward that goal, VA provides telephone coaching to family members through its Coaching Into Care (CIC) program to help get their Veterans into care. While CIC enjoys high caller satisfaction, it has shown only modest success getting Veterans into care. Blended interventions that include professional support and technology-based interventions offer promise for improving effectiveness of services. Therefore, this study tests an intervention that blends CIC calls with a web program called VA Community Reinforcement and Family Training (VA-CRAFT). VA-CRAFT is a translation of an empirically-validated model intended to help Veterans by training their family members to effectively promote care-seeking. If successful, this approach will support families and help more Veterans receive needed mental health care for PTSD.
Read the detailed description
Posttraumatic Stress Disorder (PTSD) is a highly prevalent, potentially debilitating condition afflicting many war Veterans. While efficacious treatments are available, most individuals with PTSD do not receive any mental health care. VA faces an ongoing challenge of engaging Veterans with PTSD in effective services. Recognizing the powerful influence of families on Veteran wellbeing, VA has called for increased involvement of family members in the care of Veterans with PTSD. In response, VA has created a national telephone-based support service called Coaching Into Care (CIC) to work with family members of Veterans with mental health problems who are reluctant to seek treatment. Program evaluation data show that CIC is highly valued by callers, but that only about 25% of callers with Veterans not already in care, report that their Veteran sought care over the next six months. The proposed study is a test of an innovative approach to improve outcomes by blending coaching calls with a web-based program called VA Community Reinforcement and Family Training (VA-CRAFT). VA-CRAFT is a translation of an empirically-validated model intended to help Veterans by training and supporting their family members to better care for themselves, more effectively manage their relationships, and have effective care-seeking conversations with their Veterans.
Preliminary work suggests that VA-CRAFT may be a powerful adjunct for CIC services. In a prior HSR\&D-funded pilot, the investigators' team found that family members who completed the relatively brief VA-CRAFT course alone (without any coaching) had greater decreases in caregiver burden than wait-list controls. However, qualitative interviews also suggested that participants often did not raise the issue of treatment with their Veteran loved one due to not believing such a conversation would be successful. The investigators developed CIC+VA-CRAFT with the goal of capitalizing on the strengths of both approaches (CIC and VA-CRAFT) and increasing family members' motivation, perceived ability to have treatment-seeking conversations with the Veteran, and success at engaging their Veterans in care. Initial findings from a second, NC-PTSD-funded pilot suggest that this brief, blended intervention is feasible, acceptable, and potentially more effective than CIC alone in enhancing Veteran mental health treatment initiation.
Primary Objective: The primary objective is to investigate the effectiveness of CIC+VA-CRAFT in improving Veteran treatment initiation above CIC only, without compromising the high caller satisfaction of the CIC program. To accomplish this, the investigators will use a two-group randomized controlled trial. Spouse/partners who believe their Veteran needs PTSD treatment will be randomized to CIC+VA-CRAFT or CIC only (i.e., TAU). Assessments will occur at baseline, post-treatment (month 3), and follow-up (month 6). To maximize generalizability of findings to the intended population, recruitment will use targeted social media advertising and referrals from the existing CIC program. Specific aims are:
Aim 1: Determine the effectiveness of CIC+VA-CRAFT for Veteran mental health service initiation. The investigators hypothesize that spouse/partners in CIC+VA-CRAFT will report higher rates of mental health service initiation for their Veterans than will participants in the CIC only condition.
Aim 2: Investigate caller satisfaction with CIC+VA-CRAFT relative to CIC only. The investigators hypothesize that satisfaction with CIC+VA-CRAFT will be non-inferior to satisfaction with the CIC program.
Aim 3: Conduct a process evaluation to inform potential future implementation of CIC+VA-CRAFT. Qualitative interviews with spouse/partners, their Veterans, and study and CIC coaches, will be used to inform future implementation of the CIC+VA-CRAFT intervention into the CIC program.
Exploratory Aims:
- Explore potential within-condition improvements and between-condition changes on spouse/partner and family outcomes. The investigators will test for these effects on measures of caregiver burden, psychological distress, quality of life, and family conflict and cohesion.
- Explore potential intervention mediators and moderators of Veteran mental health treatment initiation. The investigators will explore if self-efficacy, outcome expectancy, and treatment conversations mediate the effect of the intervention on mental health treatment initiation. Demographic variables, perceived Veteran symptomatology, and partner symptomatology will be explored as moderators of the effect of the intervention.
The long-term goal of this research is to establish an efficacious, efficient, scalable, and satisfying family outreach intervention that will significantly increase mental health service initiation among a high priority Veteran population while addressing the needs of their primary supporters, their family members. This proposal has been developed in collaboration with the existing VA CIC and VA-CRAFT programs and involves the leadership of these programs to facilitate the blended intervention's rapid dissemination should the trial prove successful.
- Conditions
- Stress Disorders, Post-traumatic
- Being tested
- CIC+VA-CRAFT, CIC
- Keywords
- Stress Disorders, Post-traumatic, Internet-Based Intervention, Telemedicine, Veterans
- 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.
CIC+VA-CRAFTBehavioural
Also called Coaching Into Care plus VA-CRAFT
CIC+VA-CRAFT consists of four 45-min. telephone coaching calls over 8-12 weeks, delivered by a coach following a manual, while participants are completing the VA-CRAFT for PTSD web-based course.
CICBehavioural
Also called Coaching Into Care
Coaching Into Care is an existing national VA program that provides telephone consultation and coaching to family members of Veterans with mental health needs who want to help connect them with mental health care by providing referrals, educational information, and a unique coaching service to help callers talk to their Veterans about their decision to seek care.
| Study group | Role | What they receive |
|---|---|---|
| CIC+VA-CRAFT | Experimental | Coaching Into Care plus VA-CRAFT consists of four 45-minutes telephone coaching calls over 8-12 weeks, delivered by a coach following a manual, while participants are completing the VA-CRAFT for PTSD web-based course. Receives: Behavioral: CIC+VA-CRAFT |
| CIC | Active comparator | Coaching Into Care is an existing national VA program that provides telephone consultation and coaching to family members of Veterans with mental health needs who want to help connect them with mental health care by providing referrals, educational information, and a unique coaching service to help callers talk to their Veterans about their decision to seek care. Receives: Behavioral: CIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Veteran Mental Health Service Utilization Change
Veteran mental health service initiation as reported by the enrolled partner. This will be operationalized dichotomously (whether any mental health services are initiated) for VA and non-VA services for the 3- and 6-month periods following randomization.
Measured: 3 and 6 months post-randomization
Client Satisfaction Questionnaire (CSQ; Attkisson et al., 1979)
This 8-item measure assesses general client satisfaction at post-treatment stage for the intervention delivered in the study. The Client Satisfaction Questionnaire is a self-report measure with each item score ranging from 1 to 4. The total score is derived from summing all items ranging from 1 to 32, with higher scores reflecting greater program satisfaction.
Measured: 3 months post-randomization
Secondary outcomes (4)
Montgomery Borgatta Caregiver Burden Scale( Montgomery & Borgatta, 1985)
This 22-item measure assesses the change in the objective burden, subjective stress burden, and subjective demand burden of caregiving over twelve weeks. Final score is the total sum of each item, where each item score ranges from 0 to 4 with the final score ranging from 0 to 88. The total raw score will indicate either little or no caregiver burden (0 to 20), mild to moderate caregiver burden (21 to 40), moderate to severe caregiver burden (41 to 60) or severe caregiver burden (61-88).
Measured: 3 and 6 months post-randomization
World Health Organization - Quality of Life (Brief; WHOQOL; World Health Organization, 1996))
This 26-item self-report measure assesses the change in four domains of quality of life over twelve weeks: physical health, psychological health, social relationships, and environment. Each item score ranges between 1 to 5. To assess each domain, total scores for items measuring that domain are further calculated and transformed into a 0 to 100 scale. Domain scores are in positive direction, where higher scores indicate higher quality of life.
Measured: 3 and 6 months post-randomization
Brief Symptom Inventory (BSI; Derogatis, 2000)
This 18-item self-report measure assesses the change in psychological distress and psychiatric symptoms over twelve weeks. Each item score ranges between 0 to 5, where final score of all items are aggregated and transformed into a t-score for three subscales on the Global Severity Index (GSI): somatization, depression and anxiety. Higher t-score for each subscale on the GSI indicates clinically significant symptoms.
Measured: 3 and 6 months post-randomization
Family Environment Scale (FES; Moos, 1974)
The 20-item self-report measure assesses the change in general familial relationship functioning, with subscales measuring Cohesion and Conflict over twelve weeks. Each item is a 'Yes' or 'No' item with a scoring or 1 and 0, respectively. Subscales are scored by summing scores for items measuring their component subscale, resulting in two subscale scores. The subscale scores are then used to categorize families' social climate.
Measured: 3 and 6 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start1 Apr 2021
- Primary completion2 Oct 2025
- Study completion2 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-traumaticStudies 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
- Model description
- Coaching Into Care plus VA-CRAFT consists of four 45-minutes telephone coaching calls over 8-12 weeks, delivered by a coach following a manual. Calls focus on supporting and holding the participant accountable for using the VA-CRAFT for PTSD web-based course. This course is based on Community Reinforcement and Family Training (CRAFT) which is intended to help family members of Veterans with PTSD who are resistant to seek treatment for PTSD to initiate care as well as promote the family member's wellbeing and improve their relationship with the Veteran. Calls are designed to: 1) help participants maintain motivation to complete VA-CRAFT lessons in a timely fashion by using reinforcement and motivational techniques; 2) consolidate information and implement skills that they are learning in the course through lesson review, role plays, and problem solving; and, 3) normalize and validate the challenges of having a loved one with PTSD who is reluctant to seek care (i.e., supportive caring).
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Corporal Michael J. Crescenz VA Medical Center, Minneapolis Veterans Affairs Medical Center
- Responsible party
- Sponsor
- Investigators
- Eric R Kuhn, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CASteven L. Sayers, PhD, Principal investigator, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501328
- Sponsor's protocol ID
- IIR 19-031
- Other IDs
- 5I01HX002955-02
- Status last verified
- Oct 2026
- First submitted
- 3 Aug 2020
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuhn E, Sayers S, Zimmerman L, Mackintosh MA, Owen JE, Rosen CS, Meis LA, Hagedorn HJ, Erbes CR. Promoting mental health treatment initiation of veterans with PTSD using internet-based family training and telephone coaching: Protocol for a randomized controlled trial. Contemp Clin Trials. 2025 Jul;154:107929. doi: 10.1016/j.cct.2025.107929. Epub 2025 May 2.
PubMed 40320070
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Coaching Into Care With VA-CRAFT to Promote Veteran Engagement in PTSD Care
- ClinicalTrials.gov ID
- NCT04501328
- Acronym / sponsor ID
- IIR 19-031
- Conditions
- Stress Disorders, Post-traumatic
- Keywords
- Stress Disorders, Post-traumatic, Internet-Based Intervention, Telemedicine, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Corporal Michael J. Crescenz VA Medical Center, Minneapolis Veterans Affairs Medical Center
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Posttraumatic stress disorder (PTSD) afflicts many war Veterans, but often they are reluctant to seek help despite availability of effective treatments. Family members are key sources of support who can help encourage such Veterans to initiate mental health services. Toward that goal, VA provides telephone coaching to family members through its Coaching Into Care (CIC) program to help get their Veterans into care. While CIC enjoys high caller satisfaction, it has shown only modest success getting Veterans into care. Blended interventions that include professional support and technology-based interventions offer promise for improving effectiveness of services. Therefore, this study tests an intervention that blends CIC calls with a web program called VA Community Reinforcement and Family Training (VA-CRAFT). VA-CRAFT is a translation of an empirically-validated model intended to help Veterans by training their family members to effectively promote care-seeking. If successful, this approach will support families and help more Veterans receive needed mental health care for PTSD.
Detailed description
Posttraumatic Stress Disorder (PTSD) is a highly prevalent, potentially debilitating condition afflicting many war Veterans. While efficacious treatments are available, most individuals with PTSD do not receive any mental health care. VA faces an ongoing challenge of engaging Veterans with PTSD in effective services. Recognizing the powerful influence of families on Veteran wellbeing, VA has called for increased involvement of family members in the care of Veterans with PTSD. In response, VA has created a national telephone-based support service called Coaching Into Care (CIC) to work with family members of Veterans with mental health problems who are reluctant to seek treatment. Program evaluation data show that CIC is highly valued by callers, but that only about 25% of callers with Veterans not already in care, report that their Veteran sought care over the next six months. The proposed study is a test of an innovative approach to improve outcomes by blending coaching calls with a web-based program called VA Community Reinforcement and Family Training (VA-CRAFT). VA-CRAFT is a translation of an empirically-validated model intended to help Veterans by training and supporting their family members to better care for themselves, more effectively manage their relationships, and have effective care-seeking conversations with their Veterans.
Preliminary work suggests that VA-CRAFT may be a powerful adjunct for CIC services. In a prior HSR\&D-funded pilot, the investigators' team found that family members who completed the relatively brief VA-CRAFT course alone (without any coaching) had greater decreases in caregiver burden than wait-list controls. However, qualitative interviews also suggested that participants often did not raise the issue of treatment with their Veteran loved one due to not believing such a conversation would be successful. The investigators developed CIC+VA-CRAFT with the goal of capitalizing on the strengths of both approaches (CIC and VA-CRAFT) and increasing family members' motivation, perceived ability to have treatment-seeking conversations with the Veteran, and success at engaging their Veterans in care. Initial findings from a second, NC-PTSD-funded pilot suggest that this brief, blended intervention is feasible, acceptable, and potentially more effective than CIC alone in enhancing Veteran mental health treatment initiation.
Primary Objective: The primary objective is to investigate the effectiveness of CIC+VA-CRAFT in improving Veteran treatment initiation above CIC only, without compromising the high caller satisfaction of the CIC program. To accomplish this, the investigators will use a two-group randomized controlled trial. Spouse/partners who believe their Veteran needs PTSD treatment will be randomized to CIC+VA-CRAFT or CIC only (i.e., TAU). Assessments will occur at baseline, post-treatment (month 3), and follow-up (month 6). To maximize generalizability of findings to the intended population, recruitment will use targeted social media advertising and referrals from the existing CIC program. Specific aims are:
Aim 1: Determine the effectiveness of CIC+VA-CRAFT for Veteran mental health service initiation. The investigators hypothesize that spouse/partners in CIC+VA-CRAFT will report higher rates of mental health service initiation for their Veterans than will participants in the CIC only condition.
Aim 2: Investigate caller satisfaction with CIC+VA-CRAFT relative to CIC only. The investigators hypothesize that satisfaction with CIC+VA-CRAFT will be non-inferior to satisfaction with the CIC program.
Aim 3: Conduct a process evaluation to inform potential future implementation of CIC+VA-CRAFT. Qualitative interviews with spouse/partners, their Veterans, and study and CIC coaches, will be used to inform future implementation of the CIC+VA-CRAFT intervention into the CIC program.
Exploratory Aims:
- Explore potential within-condition improvements and between-condition changes on spouse/partner and family outcomes. The investigators will test for these effects on measures of caregiver burden, psychological distress, quality of life, and family conflict and cohesion.
- Explore potential intervention mediators and moderators of Veteran mental health treatment initiation. The investigators will explore if self-efficacy, outcome expectancy, and treatment conversations mediate the effect of the intervention on mental health treatment initiation. Demographic variables, perceived Veteran symptomatology, and partner symptomatology will be explored as moderators of the effect of the intervention.
The long-term goal of this research is to establish an efficacious, efficient, scalable, and satisfying family outreach intervention that will significantly increase mental health service initiation among a high priority Veteran population while addressing the needs of their primary supporters, their family members. This proposal has been developed in collaboration with the existing VA CIC and VA-CRAFT programs and involves the leadership of these programs to facilitate the blended intervention's rapid dissemination should the trial prove successful.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Coaching Into Care plus VA-CRAFT consists of four 45-minutes telephone coaching calls over 8-12 weeks, delivered by a coach following a manual. Calls focus on supporting and holding the participant accountable for using the VA-CRAFT for PTSD web-based course. This course is based on Community Reinforcement and Family Training (CRAFT) which is intended to help family members of Veterans with PTSD who are resistant to seek treatment for PTSD to initiate care as well as promote the family member's wellbeing and improve their relationship with the Veteran. Calls are designed to: 1) help participants maintain motivation to complete VA-CRAFT lessons in a timely fashion by using reinforcement and motivational techniques; 2) consolidate information and implement skills that they are learning in the course through lesson review, role plays, and problem solving; and, 3) normalize and validate the challenges of having a loved one with PTSD who is reluctant to seek care (i.e., supportive caring).
| Arm | Type | Receives |
|---|---|---|
| CIC+VA-CRAFT | Experimental | Behavioral: CIC+VA-CRAFTCoaching Into Care plus VA-CRAFT consists of four 45-minutes telephone coaching calls over 8-12 weeks, delivered by a coach following a manual, while participants are completing the VA-CRAFT for PTSD web-based course. |
| CIC | Active comparator | Behavioral: CICCoaching Into Care is an existing national VA program that provides telephone consultation and coaching to family members of Veterans with mental health needs who want to help connect them with mental health care by providing referrals, educational information, and a unique coaching service to help callers talk to their Veterans about their decision to seek care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The target population consists of partners and first-degree family members who are in regular contact with a Veteran from any service era who believe that their Veteran is suffering from significant symptoms of PTSD and in need of mental health care.
- reporting being in an intimate relationship (dating, engaged, or married) with a Veteran or a first degree family member of a Veteran
- reporting that their Veteran is not engaged in mental health care and has not been for the past 6 months
- reporting perceived symptoms of PTSD in their Veteran
- reporting frequent contact with their Veteran (some verbal or face-to-face contact for 36 of the past 90 days)
Key exclusion criteria (3 listed)
- reporting by the potential participant that they are subject to domestic violence and may not feel safe engaging in CIC+VA-CRAFT activities
- we will exclude partners reporting severe intimate partner violence on the brief Conflict Tactics Scale 2 Short Form with their Veteran in the past 6 months
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 |
|---|---|---|
| CIC+VA-CRAFTAlso: Coaching Into Care plus VA-CRAFTCIC+VA-CRAFT consists of four 45-min. telephone coaching calls over 8-12 weeks, delivered by a coach following a manual, while participants are completing the VA-CRAFT for PTSD web-based course. | Behavioural | CIC+VA-CRAFT |
| CICAlso: Coaching Into CareCoaching Into Care is an existing national VA program that provides telephone consultation and coaching to family members of Veterans with mental health needs who want to help connect them with mental health care by providing referrals, educational information, and a unique coaching service to help callers talk to their Veterans about their decision to seek care. | Behavioural | CIC |
Primary outcome
Veteran Mental Health Service Utilization Change
Time frame: 3 and 6 months post-randomization
Veteran mental health service initiation as reported by the enrolled partner. This will be operationalized dichotomously (whether any mental health services are initiated) for VA and non-VA services for the 3- and 6-month periods following randomization.
Client Satisfaction Questionnaire (CSQ; Attkisson et al., 1979)
Time frame: 3 months post-randomization
This 8-item measure assesses general client satisfaction at post-treatment stage for the intervention delivered in the study. The Client Satisfaction Questionnaire is a self-report measure with each item score ranging from 1 to 4. The total score is derived from summing all items ranging from 1 to 32, with higher scores reflecting greater program satisfaction.
4 secondary outcomes
Montgomery Borgatta Caregiver Burden Scale( Montgomery & Borgatta, 1985)
Time frame: 3 and 6 months post-randomization
World Health Organization - Quality of Life (Brief; WHOQOL; World Health Organization, 1996))
Time frame: 3 and 6 months post-randomization
Brief Symptom Inventory (BSI; Derogatis, 2000)
Time frame: 3 and 6 months post-randomization
Family Environment Scale (FES; Moos, 1974)
Time frame: 3 and 6 months post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Results publication: PubMed 40320070Kuhn E, Sayers S, Zimmerman L, Mackintosh MA, Owen JE, Rosen CS, Meis LA, Hagedorn HJ, Erbes CR. Promoting mental health treatment initiation of veterans with PTSD using internet-based family training and telephone coaching: Protocol for a randomized controlled trial. Contemp Clin Trials. 2025 Jul;154:107929. doi: 10.1016/j.cct.2025.107929. Epub 2025 May 2.
- 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.
Eric R Kuhn, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
Steven L. Sayers, PhD principal investigator
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CIC+VA-CRAFT and CIC in people with Stress Disorders, Post-traumatic, 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 6 inclusion and 3 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 27 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Veteran Mental Health Service Utilization Change (time frame: 3 and 6 months post-randomization). The study lists 2 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 NCT04501328, which also lists 1 linked publication.
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 27 Oct 2026.