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Behavioral Intervention

CIC + VA-CRAFT for PTSD

N/A

Recruiting

Led By Steven L. Sayers, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Being 18 years of age or older.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 and 6 months post-randomization

Awards & highlights

Study Summary

This trial tests an intervention that blends professional support (Coaching Into Care) with a web program (VA Community Reinforcement and Family Training) to help Veterans with PTSD by training their family members to effectively promote care-seeking.

Who is the study for?

This trial is for partners of Veterans who suspect their Veteran has PTSD and needs mental health care. Partners should be in regular contact with the Veteran, not currently receiving mental health treatment, have internet and phone access, and be over 18. Those experiencing domestic violence or severe conflict with the Veteran are excluded.Check my eligibility

What is being tested?

The study tests a blended intervention combining telephone coaching (CIC) with an online program (VA-CRAFT) designed to help family members encourage Veterans to seek care for PTSD. The effectiveness of this combined approach versus CIC alone in engaging Veterans in mental health services is being evaluated.See study design

What are the potential side effects?

Since this trial involves coaching and web-based training rather than medical treatments, traditional side effects are not applicable. However, participants may experience emotional distress or discomfort while learning to support their Veteran partner.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 and 6 months post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 and 6 months post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 and 6 months post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Client Satisfaction Questionnaire (CSQ; Attkisson et al., 1979)

Veteran Mental Health Service Utilization Change

Secondary outcome measures

Brief Symptom Inventory (BSI; Derogatis, 2000)

Family Environment Scale (FES; Moos, 1974)

Montgomery Borgatta Caregiver Burden Scale( Montgomery & Borgatta, 1985)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CIC+VA-CRAFTExperimental Treatment1 Intervention

Coaching Into Care plus 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.

Group II: CICActive Control1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Minneapolis Veterans Affairs Medical CenterFED

72 Previous Clinical Trials

14,690 Total Patients Enrolled

Corporal Michael J. Crescenz VA Medical CenterFED

30 Previous Clinical Trials

10,286 Total Patients Enrolled

VA Office of Research and DevelopmentLead Sponsor

1,611 Previous Clinical Trials

3,305,054 Total Patients Enrolled

Media Library

CIC (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04501328 — N/A

Post-Traumatic Stress Disorder Research Study Groups: CIC, CIC+VA-CRAFT

Post-Traumatic Stress Disorder Clinical Trial 2023: CIC Highlights & Side Effects. Trial Name: NCT04501328 — N/A

CIC (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04501328 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide an estimate of the number of participants involved in this trial?

"Yes, current information on clinicaltrials.gov confirms that this medical research is currently recruiting participants. The study was initially uploaded on April 1st 2021 and recently updated on the fifth of April 2022 with a need for 230 test subjects from one location."

Answered by AI

Is there an opportunity to become involved in this experiment at present?

"Affirmative. Clinical trials website documentation affirms that this investigation is presently enrolling participants. The trial was originally posted on April 1st 2021 and updated most recently on the 5th of April 2022, with 230 patients sought from a single site."

Answered by AI

What objectives has this medical study been designed to accomplish?

"The primary outcome of this research, assessed over a 3 and 6 month post-randomization period, is the Client Satisfaction Questionnaire (CSQ; Attkisson et al., 1979). Additionally, the Brief Symptom Inventory (BSI; Derogatis, 2000), Family Environment Scale (FES; Moos, 1974) and World Health Organization - Quality of Life (Brief; WHOQOL; World Health Organization 1996)) are utilized as secondary benchmarks for evaluating psychological distress symptoms in patients. Every indicator has an individual scoring system from 0 to 5 or 1 to 100 that translates into a Global Severity Index t-"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Randomized Controlled Trial of Coaching Into Care With VA-CRAFT to Promote Veteran Engagement in PTSD Care

2021. "A Randomized Controlled Trial of Coaching Into Care With VA-CRAFT to Promote Veteran Engagement in PTSD Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04501328.