NCT03246646

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

June 30, 2021

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

2.3 years

First QC Date

August 7, 2017

Results QC Date

March 10, 2021

Last Update Submit

June 9, 2021

Conditions

Keywords

Substance AbuseAlcohol Abuse

Outcome Measures

Primary Outcomes (1)

  • Number of Veteran's Engaged in Mental Health Care

    Veteran's mental health care engagement was assessed from CSO participants' report.

    At any point during study involvement, up to 1 year after enrollment

Study Arms (2)

Coaching + VA CRAFT

EXPERIMENTAL

Telephone coaching along with web-based CRAFT course

Behavioral: Coaching

Treatment as usual

OTHER

Treatment as usual matched comparison

Behavioral: Coaching

Interventions

CoachingBEHAVIORAL

Telephone coaching was provided in a series of telephone based sessions with CSO participants

Coaching + VA CRAFTTreatment as usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (29)

  • 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

    BACKGROUND
  • 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.

    PMID: 21277712BACKGROUND
  • 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.

    PMID: 24183763BACKGROUND
  • 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.

    PMID: 20513681BACKGROUND
  • 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.

    PMID: 24839077BACKGROUND
  • 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.

    PMID: 16157233BACKGROUND
  • 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.

    PMID: 30328689BACKGROUND
  • 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.

    PMID: 25219288BACKGROUND
  • 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.

    PMID: 16461451BACKGROUND
  • 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.

    PMID: 11419236BACKGROUND
  • 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.

    PMID: 33167815BACKGROUND
  • Meyers RJ, Roozen HG, Smith JE. The community reinforcement approach: an update of the evidence. Alcohol Res Health. 2011;33(4):380-8.

    PMID: 23580022BACKGROUND
  • 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.

    PMID: 20626372BACKGROUND
  • 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.

    PMID: 21545667BACKGROUND
  • 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.

    PMID: 20873894BACKGROUND
  • 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.

    PMID: 15612844BACKGROUND
  • 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.

    PMID: 31621884BACKGROUND
  • 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.

    PMID: 7722987BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 9203116BACKGROUND
  • 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.

    PMID: 9881538BACKGROUND
  • 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.

    PMID: 11556941BACKGROUND
  • 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.

    PMID: 16377369BACKGROUND
  • 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.

    PMID: 16423122BACKGROUND
  • 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.

    PMID: 14645769BACKGROUND
  • 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.

    PMID: 16050884BACKGROUND
  • 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.

    PMID: 21135026BACKGROUND
  • Weathers, F.W., J.A. Huska, and T.M. Keane, PCL-C for DSM-IV. 1991, Boston: National Center for PTSD - Behavioral Science Division.

    BACKGROUND
  • Rosner, B., Fundamentals of Biostatistics. 2011, Boston: Brooks/Cole.

    BACKGROUND

MeSH Terms

Conditions

Substance-Related DisordersAlcoholism

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersAlcohol-Related Disorders

Limitations and Caveats

The limitations of the design include that this was a pilot study with a primary goal of examining the feasibility of the intervention rather than determine the efficacy of the intervention. The treatment as usual comparison group served only as a benchmark for understanding the potential effectiveness.

Results Point of Contact

Title
Steven L. Sayers
Organization
CMC VA Medical Center

Study Officials

  • Steven L. Sayers, PhD

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2017

First Posted

August 11, 2017

Study Start

June 14, 2017

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

June 30, 2021

Results First Posted

June 30, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations