Substance AbuseVA-CRAFTNCT03246646
Telephone Coaching of Family Members of Veterans With Substance Abuse Problems
A study testing Coaching in people with Substance Abuse, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This project will develop and pilot test an enhanced, telephone "coaching" intervention to help family members concerned about a Veteran of the wars in Iraq or Afghanistan who needs to seek treatment for a substance abuse problem. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2017to 30 Sep 2019
- 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
- CSO is a sibling, spouse/ intimate partner, or parent of a US military Veteran who served in Iraq or Afghanistan since 2001
- by the report of the CSO the Veteran of interest has a substance abuse problem that has led to interpersonal, legal, occupational, and/or health related negative consequences
- the CSO reports that the Veteran is not currently receiving treatment for this problem
- the CSO has contact 4+times/week and lives with or within 30 min. of the Veteran.
Who cannot join
- CSO has a SUD (Form 90, see Measures)
- the Veteran is currently incarcerated
- the CSO has no computer or other device with Internet access able to view video content
- the CSO or Veteran likely has a psychotic disorder (CSO report on the MINI) (see Measures)
- the CSO's involvement in a "coaching" intervention meant to encourage the Veteran to actively consider to seek care places the CSO at risk on a physical or psychological basis
- Callers who do not have access to a safe phone line will not be referred to the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104
About this study
This project will develop and pilot test an enhanced, telephone "coaching" intervention to help family members concerned about a Veteran of the wars in Iraq or Afghanistan who needs to seek treatment for a substance abuse problem.
Read the detailed description
The investigators will first develop a detailed manual for Coaching-CRAFT, which will be a telephone-based model of coaching that uses the web-version of an intervention already developed and available to the investigators. The investigators will conduct a preliminary nonrandomized feasibility trial of the use of Coaching-CRAFT with a sample of 50 family member callers recruited from VA's Coaching Into Care call center. Later in the study, the investigators will recruit up to 50 Veterans whose family members also participated in this study. Since the 'Coaching Into Care' telephone-based call center located at the Corporal Michael J. Crescenz VA Medical Center (CMCVAMC) is a national call center, study subjects (non-Veterans and Veterans) will be from all parts of the United States.
Family members (spouses, siblings, or parents) of Veteran will be recruited from Coaching Into Care, and offered telephone-based coaching to the family member regarding their concern that the Veteran has a substance abuse problem and does not want to seek treatment. The program will involve approximately 12 telephone calls over 4-6 months. Family members will be assessed for their own mental health symptoms, their perception of their Veteran's mental health symptoms and substance use, his or her treatment, as well as their perception of burden on the relationship with the Veteran. These assessments will occur at study entry, 6 months, and 12 months after study entry. Veteran's perceptions of the intervention will be sought at 12 months, whenever safe and practical. For Veterans who are not approached to participate in the study, VHA administrative data will be sought through a HIPAA Waiver to confirm any possible mental health and or substance abuse treatment the Veteran has received. Rates of initiation of treatment will be compared to QA data from the Coaching Into Care call center.
- Conditions
- Substance Abuse
- Being tested
- Coaching
- Keywords
- Substance Abuse, Alcohol Abuse
- Medical subject headings
- Substance-Related Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoachingBehavioural
Telephone coaching was provided in a series of telephone based sessions with CSO participants
| Study group | Role | What they receive |
|---|---|---|
| Coaching + VA CRAFT | Experimental | Telephone coaching along with web-based CRAFT course Receives: Behavioral: Coaching |
| Treatment as usual | Other | Treatment as usual matched comparison Receives: Behavioral: Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Veteran's Engaged in Mental Health Care
Veteran's mental health care engagement was assessed from CSO participants' report.
Measured: At any point during study involvement, up to 1 year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start14 Jun 2017
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
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 (29)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The intervention will be approximately 12, 30-45 min. telephone sessions, every 2-3 weeks, and will last 4-6 months. The Coach helps the participant individualize the content of a web-based course (VA-CRAFT) based on an intervention to encourage a loved one to seek treatment for substance abuse. The VA-CRAFT course has 8 modules that follow the original CRAFT intervention: 1) Introduction, 2) Overview, 3) Getting Started: Safety Planning, 4) Understanding substance abuse, 5) How to respond to substance abuse, 6) Rebuilding your life together, 7) Helping someone consider treatment, 8) Wrapping up. The goals include understanding triggers and long-term reinforcement of substance misuse, ignoring unhealthy behaviors and rewarding healthy behaviors, getting support, and how to help the CSO caller help the Veteran enter treatment. The participants in the active intervention will be compared to a treatment as usual, matched comparator group drawn from regular clinical operations.
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Steven L. Sayers, PhD, Principal investigator, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246646
- Sponsor's protocol ID
- D2070-P
- Acronym
- VA-CRAFT
- Status last verified
- Jun 2021
- First submitted
- 7 Aug 2017
- Last updated
- 30 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Epidemiology Program: Post-Deployment Health Group, Analysis of VA Health Care Utilization among Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans: Cumulative from 1st Qtr FY 2002 through 4th Qtr FY 2014 (October 1, 2001 - September 30, 2014), Office of Public Health, Editor. 2015, Department of Veterans Affairs: Washington, DC. https://www.publichealth.va.gov/docs/epidemiology/healthcare-utilization-report-fy2015-qtr1.pdf
Seal KH, Cohen G, Waldrop A, Cohen BE, Maguen S, Ren L. Substance use disorders in Iraq and Afghanistan veterans in VA healthcare, 2001-2010: Implications for screening, diagnosis and treatment. Drug Alcohol Depend. 2011 Jul 1;116(1-3):93-101. doi: 10.1016/j.drugalcdep.2010.11.027. Epub 2011 Jan 31.
PubMed 21277712Hearne CR. Predictors of Operation Enduring Freedom/Operation Iraqi Freedom veterans' engagement in mental health treatment. Mil Med. 2013 Nov;178(11):1183-7. doi: 10.7205/MILMED-D-13-00245.
PubMed 24183763Kim PY, Thomas JL, Wilk JE, Castro CA, Hoge CW. Stigma, barriers to care, and use of mental health services among active duty and National Guard soldiers after combat. Psychiatr Serv. 2010 Jun;61(6):582-8. doi: 10.1176/ps.2010.61.6.582.
PubMed 20513681Vogt D, Fox AB, Di Leone BA. Mental health beliefs and their relationship with treatment seeking among U.S. OEF/OIF veterans. J Trauma Stress. 2014 Jun;27(3):307-13. doi: 10.1002/jts.21919. Epub 2014 May 16.
PubMed 24839077Stinson FS, Grant BF, Dawson DA, Ruan WJ, Huang B, Saha T. Comorbidity between DSM-IV alcohol and specific drug use disorders in the United States: results from the National Epidemiologic Survey on Alcohol and Related Conditions. Drug Alcohol Depend. 2005 Oct 1;80(1):105-16. doi: 10.1016/j.drugalcdep.2005.03.009. Epub 2005 Apr 18.
PubMed 16157233Batten S, Drapalski L, Decker L, DeViva C, Morris J, Mann A, Dixon B. Veteran interest in family involvement in PTSD treatment. Psychol Serv. 2009 Aug 10;6(3):184-189. doi: 10.1037/a0015392.
PubMed 30328689Hershenberg R, Mavandadi S, Klaus JR, Oslin DW, Sayers SL. Veteran preferences for romantic partner involvement in depression treatment. Gen Hosp Psychiatry. 2014 Nov-Dec;36(6):757-9. doi: 10.1016/j.genhosppsych.2014.08.001. Epub 2014 Aug 16.
PubMed 25219288Sayers SL, White T, Zubritsky C, Oslin DW. Family involvement in the care of healthy medical outpatients. Fam Pract. 2006 Jun;23(3):317-24. doi: 10.1093/fampra/cmi114. Epub 2006 Feb 3.
PubMed 16461451Marlowe DB, Merikle EP, Kirby KC, Festinger DS, McLellan AT. Multidimensional assessment of perceived treatment-entry pressures among substance abusers. Psychol Addict Behav. 2001 Jun;15(2):97-108. doi: 10.1037//0893-164x.15.2.97.
PubMed 11419236Sayers SL, Hess TH, Whitted P, Straits-Troster KA, Glynn SM. Coaching Into Care: Veterans Affairs Telephone-Based Service for Concerned Family Members of Military Veterans. Psychiatr Serv. 2021 Jan 1;72(1):107-109. doi: 10.1176/appi.ps.201900113. Epub 2020 Nov 10.
PubMed 33167815Meyers RJ, Roozen HG, Smith JE. The community reinforcement approach: an update of the evidence. Alcohol Res Health. 2011;33(4):380-8.
PubMed 23580022Roozen HG, de Waart R, van der Kroft P. Community reinforcement and family training: an effective option to engage treatment-resistant substance-abusing individuals in treatment. Addiction. 2010 Oct;105(10):1729-38. doi: 10.1111/j.1360-0443.2010.03016.x.
PubMed 20626372McKay JR, Van Horn D, Oslin DW, Ivey M, Drapkin ML, Coviello DM, Yu Q, Lynch KG. Extended telephone-based continuing care for alcohol dependence: 24-month outcomes and subgroup analyses. Addiction. 2011 Oct;106(10):1760-9. doi: 10.1111/j.1360-0443.2011.03483.x. Epub 2011 Aug 8.
PubMed 21545667McKay JR, Van Horn DH, Oslin DW, Lynch KG, Ivey M, Ward K, Drapkin ML, Becher JR, Coviello DM. A randomized trial of extended telephone-based continuing care for alcohol dependence: within-treatment substance use outcomes. J Consult Clin Psychol. 2010 Dec;78(6):912-23. doi: 10.1037/a0020700.
PubMed 20873894
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Coaching of Family Members of Veterans With Substance Abuse Problems
- ClinicalTrials.gov ID
- NCT03246646
- Acronym / sponsor ID
- VA-CRAFT / D2070-P
- Conditions
- Substance Abuse
- Keywords
- Substance Abuse, Alcohol Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 11 Aug 2017 (actual)
- Results
- Posted 30 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will develop and pilot test an enhanced, telephone "coaching" intervention to help family members concerned about a Veteran of the wars in Iraq or Afghanistan who needs to seek treatment for a substance abuse problem.
Detailed description
The investigators will first develop a detailed manual for Coaching-CRAFT, which will be a telephone-based model of coaching that uses the web-version of an intervention already developed and available to the investigators. The investigators will conduct a preliminary nonrandomized feasibility trial of the use of Coaching-CRAFT with a sample of 50 family member callers recruited from VA's Coaching Into Care call center. Later in the study, the investigators will recruit up to 50 Veterans whose family members also participated in this study. Since the 'Coaching Into Care' telephone-based call center located at the Corporal Michael J. Crescenz VA Medical Center (CMCVAMC) is a national call center, study subjects (non-Veterans and Veterans) will be from all parts of the United States.
Family members (spouses, siblings, or parents) of Veteran will be recruited from Coaching Into Care, and offered telephone-based coaching to the family member regarding their concern that the Veteran has a substance abuse problem and does not want to seek treatment. The program will involve approximately 12 telephone calls over 4-6 months. Family members will be assessed for their own mental health symptoms, their perception of their Veteran's mental health symptoms and substance use, his or her treatment, as well as their perception of burden on the relationship with the Veteran. These assessments will occur at study entry, 6 months, and 12 months after study entry. Veteran's perceptions of the intervention will be sought at 12 months, whenever safe and practical. For Veterans who are not approached to participate in the study, VHA administrative data will be sought through a HIPAA Waiver to confirm any possible mental health and or substance abuse treatment the Veteran has received. Rates of initiation of treatment will be compared to QA data from the Coaching Into Care call center.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention will be approximately 12, 30-45 min. telephone sessions, every 2-3 weeks, and will last 4-6 months. The Coach helps the participant individualize the content of a web-based course (VA-CRAFT) based on an intervention to encourage a loved one to seek treatment for substance abuse. The VA-CRAFT course has 8 modules that follow the original CRAFT intervention: 1) Introduction, 2) Overview, 3) Getting Started: Safety Planning, 4) Understanding substance abuse, 5) How to respond to substance abuse, 6) Rebuilding your life together, 7) Helping someone consider treatment, 8) Wrapping up. The goals include understanding triggers and long-term reinforcement of substance misuse, ignoring unhealthy behaviors and rewarding healthy behaviors, getting support, and how to help the CSO caller help the Veteran enter treatment. The participants in the active intervention will be compared to a treatment as usual, matched comparator group drawn from regular clinical operations.
| Arm | Type | Receives |
|---|---|---|
| Coaching + VA CRAFT | Experimental | Behavioral: CoachingTelephone coaching along with web-based CRAFT course |
| Treatment as usual | Other | Behavioral: CoachingTreatment as usual matched comparison |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CSO is a sibling, spouse/ intimate partner, or parent of a US military Veteran who served in Iraq or Afghanistan since 2001
- by the report of the CSO the Veteran of interest has a substance abuse problem that has led to interpersonal, legal, occupational, and/or health related negative consequences
- the CSO reports that the Veteran is not currently receiving treatment for this problem
- the CSO has contact 4+times/week and lives with or within 30 min. of the Veteran.
Key exclusion criteria (6 listed)
- CSO has a SUD (Form 90, see Measures)
- the Veteran is currently incarcerated
- the CSO has no computer or other device with Internet access able to view video content
- the CSO or Veteran likely has a psychotic disorder (CSO report on the MINI) (see Measures)
- the CSO's involvement in a "coaching" intervention meant to encourage the Veteran to actively consider to seek care places the CSO at risk on a physical or psychological basis
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 |
|---|---|---|
| CoachingTelephone coaching was provided in a series of telephone based sessions with CSO participants | Behavioural | Coaching + VA CRAFT, Treatment as usual |
Primary outcome
Number of Veteran's Engaged in Mental Health Care
Time frame: At any point during study involvement, up to 1 year after enrollment
Veteran's mental health care engagement was assessed from CSO participants' report.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundEpidemiology Program: Post-Deployment Health Group, Analysis of VA Health Care Utilization among Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans: Cumulative from 1st Qtr FY 2002 through 4th Qtr FY 2014 (October 1, 2001 - September 30, 2014), Office of Public Health, Editor. 2015, Department of Veterans Affairs: Washington, DC. https://www.publichealth.va.gov/docs/epidemiology/healthcare-utilization-report-fy2015-qtr1.pdf
- Background: PubMed 21277712Seal KH, Cohen G, Waldrop A, Cohen BE, Maguen S, Ren L. Substance use disorders in Iraq and Afghanistan veterans in VA healthcare, 2001-2010: Implications for screening, diagnosis and treatment. Drug Alcohol Depend. 2011 Jul 1;116(1-3):93-101. doi: 10.1016/j.drugalcdep.2010.11.027. Epub 2011 Jan 31.
- Background: PubMed 24183763Hearne CR. Predictors of Operation Enduring Freedom/Operation Iraqi Freedom veterans' engagement in mental health treatment. Mil Med. 2013 Nov;178(11):1183-7. doi: 10.7205/MILMED-D-13-00245.
- Background: PubMed 20513681Kim PY, Thomas JL, Wilk JE, Castro CA, Hoge CW. Stigma, barriers to care, and use of mental health services among active duty and National Guard soldiers after combat. Psychiatr Serv. 2010 Jun;61(6):582-8. doi: 10.1176/ps.2010.61.6.582.
- Background: PubMed 24839077Vogt D, Fox AB, Di Leone BA. Mental health beliefs and their relationship with treatment seeking among U.S. OEF/OIF veterans. J Trauma Stress. 2014 Jun;27(3):307-13. doi: 10.1002/jts.21919. Epub 2014 May 16.
- Background: PubMed 16157233Stinson FS, Grant BF, Dawson DA, Ruan WJ, Huang B, Saha T. Comorbidity between DSM-IV alcohol and specific drug use disorders in the United States: results from the National Epidemiologic Survey on Alcohol and Related Conditions. Drug Alcohol Depend. 2005 Oct 1;80(1):105-16. doi: 10.1016/j.drugalcdep.2005.03.009. Epub 2005 Apr 18.
- Background: PubMed 30328689Batten S, Drapalski L, Decker L, DeViva C, Morris J, Mann A, Dixon B. Veteran interest in family involvement in PTSD treatment. Psychol Serv. 2009 Aug 10;6(3):184-189. doi: 10.1037/a0015392.
- Background: PubMed 25219288Hershenberg R, Mavandadi S, Klaus JR, Oslin DW, Sayers SL. Veteran preferences for romantic partner involvement in depression treatment. Gen Hosp Psychiatry. 2014 Nov-Dec;36(6):757-9. doi: 10.1016/j.genhosppsych.2014.08.001. Epub 2014 Aug 16.
- Background: PubMed 16461451Sayers SL, White T, Zubritsky C, Oslin DW. Family involvement in the care of healthy medical outpatients. Fam Pract. 2006 Jun;23(3):317-24. doi: 10.1093/fampra/cmi114. Epub 2006 Feb 3.
- Background: PubMed 11419236Marlowe DB, Merikle EP, Kirby KC, Festinger DS, McLellan AT. Multidimensional assessment of perceived treatment-entry pressures among substance abusers. Psychol Addict Behav. 2001 Jun;15(2):97-108. doi: 10.1037//0893-164x.15.2.97.
- Background: PubMed 33167815Sayers SL, Hess TH, Whitted P, Straits-Troster KA, Glynn SM. Coaching Into Care: Veterans Affairs Telephone-Based Service for Concerned Family Members of Military Veterans. Psychiatr Serv. 2021 Jan 1;72(1):107-109. doi: 10.1176/appi.ps.201900113. Epub 2020 Nov 10.
- Background: PubMed 23580022Meyers RJ, Roozen HG, Smith JE. The community reinforcement approach: an update of the evidence. Alcohol Res Health. 2011;33(4):380-8.
- 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.
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 Coaching in people with Substance Abuse, 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 4 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 30 Jun 2021. 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 30 Jun 2021). 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?
Number of Veteran's Engaged in Mental Health Care (time frame: At any point during study involvement, up to 1 year after enrollment). 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 NCT03246646, which also lists 29 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 30 Jun 2021.