search
Back to results

Telephone Coaching of Family Members of Veterans With Substance Abuse Problems (VA-CRAFT)

Primary Purpose

Substance Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coaching
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Substance Abuse focused on measuring Substance Abuse, Alcohol Abuse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Coaching + VA CRAFT

Treatment as usual

Arm Description

Telephone coaching along with web-based CRAFT course

Treatment as usual matched comparison

Outcomes

Primary Outcome Measures

Number of Veteran's Engaged in Mental Health Care
Veteran's mental health care engagement was assessed from CSO participants' report.

Secondary Outcome Measures

Full Information

First Posted
August 7, 2017
Last Updated
June 9, 2021
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT03246646
Brief Title
Telephone Coaching of Family Members of Veterans With Substance Abuse Problems
Acronym
VA-CRAFT
Official Title
Telephone Coaching of Family Members of Veterans With Substance Abuse Problems
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 14, 2017 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse
Keywords
Substance Abuse, Alcohol Abuse

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coaching + VA CRAFT
Arm Type
Experimental
Arm Description
Telephone coaching along with web-based CRAFT course
Arm Title
Treatment as usual
Arm Type
Other
Arm Description
Treatment as usual matched comparison
Intervention Type
Behavioral
Intervention Name(s)
Coaching
Intervention Description
Telephone coaching was provided in a series of telephone based sessions with CSO participants
Primary Outcome Measure Information:
Title
Number of Veteran's Engaged in Mental Health Care
Description
Veteran's mental health care engagement was assessed from CSO participants' report.
Time Frame
At any point during study involvement, up to 1 year after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven L. Sayers, PhD
Organizational Affiliation
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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
Results Reference
background
PubMed Identifier
21277712
Citation
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.
Results Reference
background
PubMed Identifier
24183763
Citation
Hearne 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.
Results Reference
background
PubMed Identifier
20513681
Citation
Kim 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.
Results Reference
background
PubMed Identifier
24839077
Citation
Vogt 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.
Results Reference
background
PubMed Identifier
16157233
Citation
Stinson 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.
Results Reference
background
PubMed Identifier
30328689
Citation
Batten 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.
Results Reference
background
PubMed Identifier
25219288
Citation
Hershenberg 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.
Results Reference
background
PubMed Identifier
16461451
Citation
Sayers 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.
Results Reference
background
PubMed Identifier
11419236
Citation
Marlowe 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.
Results Reference
background
PubMed Identifier
33167815
Citation
Sayers 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.
Results Reference
background
PubMed Identifier
23580022
Citation
Meyers RJ, Roozen HG, Smith JE. The community reinforcement approach: an update of the evidence. Alcohol Res Health. 2011;33(4):380-8.
Results Reference
background
PubMed Identifier
20626372
Citation
Roozen 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. Erratum In: Addiction. 2010 Nov;105(11):2040.
Results Reference
background
PubMed Identifier
21545667
Citation
McKay 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.
Results Reference
background
PubMed Identifier
20873894
Citation
McKay 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.
Results Reference
background
PubMed Identifier
15612844
Citation
McKay JR, Lynch KG, Shepard DS, Ratichek S, Morrison R, Koppenhaver J, Pettinati HM. The effectiveness of telephone-based continuing care in the clinical management of alcohol and cocaine use disorders: 12-month outcomes. J Consult Clin Psychol. 2004 Dec;72(6):967-79. doi: 10.1037/0022-006X.72.6.967.
Results Reference
background
PubMed Identifier
31621884
Citation
Erbes CR, Kuhn E, Polusny MA, Ruzek JI, Spoont M, Meis LA, Gifford E, Weingardt KR, Campbell EH, Oleson H, Taylor BC. A Pilot Trial of Online Training for Family Well-Being and Veteran Treatment Initiation for PTSD. Mil Med. 2020 Mar 2;185(3-4):401-408. doi: 10.1093/milmed/usz326.
Results Reference
background
PubMed Identifier
7722987
Citation
Miller WR, Del Boca FK. Measurement of drinking behavior using the Form 90 family of instruments. J Stud Alcohol Suppl. 1994 Dec;12:112-8. doi: 10.15288/jsas.1994.s12.112.
Results Reference
background
Citation
Del Boca, F.K. and J.M. Brown, Issues in the development of reliable measures in addictions research: Introduction to Project MATCH assessment strategies. Psychology of Addictive Behaviors, 1996. 10(2): p. 67-74.
Results Reference
background
PubMed Identifier
9203116
Citation
Tonigan JS, Miller WR, Brown JM. The reliability of Form 90: an instrument for assessing alcohol treatment outcome. J Stud Alcohol. 1997 Jul;58(4):358-64. doi: 10.15288/jsa.1997.58.358.
Results Reference
background
PubMed Identifier
9881538
Citation
Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
Results Reference
background
PubMed Identifier
11556941
Citation
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Results Reference
background
PubMed Identifier
16377369
Citation
Martin A, Rief W, Klaiberg A, Braehler E. Validity of the Brief Patient Health Questionnaire Mood Scale (PHQ-9) in the general population. Gen Hosp Psychiatry. 2006 Jan-Feb;28(1):71-7. doi: 10.1016/j.genhosppsych.2005.07.003.
Results Reference
background
PubMed Identifier
16423122
Citation
Oslin DW, Ross J, Sayers S, Murphy J, Kane V, Katz IR. Screening, assessment, and management of depression in VA primary care clinics. The Behavioral Health Laboratory. J Gen Intern Med. 2006 Jan;21(1):46-50. doi: 10.1111/j.1525-1497.2005.0267.x.
Results Reference
background
PubMed Identifier
14645769
Citation
Oslin DW, Sayers S, Ross J, Kane V, Ten Have T, Conigliaro J, Cornelius J. Disease management for depression and at-risk drinking via telephone in an older population of veterans. Psychosom Med. 2003 Nov-Dec;65(6):931-7. doi: 10.1097/01.psy.0000097335.35776.fb.
Results Reference
background
PubMed Identifier
16050884
Citation
Pinto-Meza A, Serrano-Blanco A, Penarrubia MT, Blanco E, Haro JM. Assessing depression in primary care with the PHQ-9: can it be carried out over the telephone? J Gen Intern Med. 2005 Aug;20(8):738-42. doi: 10.1111/j.1525-1497.2005.0144.x.
Results Reference
background
PubMed Identifier
21135026
Citation
Savundranayagam MY, Montgomery RJ, Kosloski K. A dimensional analysis of caregiver burden among spouses and adult children. Gerontologist. 2011 Jun;51(3):321-31. doi: 10.1093/geront/gnq102. Epub 2010 Dec 6.
Results Reference
background
Citation
Weathers, F.W., J.A. Huska, and T.M. Keane, PCL-C for DSM-IV. 1991, Boston: National Center for PTSD - Behavioral Science Division.
Results Reference
background
Citation
Rosner, B., Fundamentals of Biostatistics. 2011, Boston: Brooks/Cole.
Results Reference
background

Learn more about this trial

Telephone Coaching of Family Members of Veterans With Substance Abuse Problems

We'll reach out to this number within 24 hrs