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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coaching + VA CRAFT | Experimental | Telephone coaching along with web-based CRAFT course |
|
| Treatment as usual | Other | Treatment as usual matched comparison |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coaching | Behavioral | Telephone coaching was provided in a series of telephone based sessions with CSO participants |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven L. Sayers, PhD | Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 21277712 | 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. | |
| 24183763 |
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Potential participants were recruited from the callers who reached a staff member of the Coaching Into Care (CIC) program. Those interested in considering the research study were screened by a study staff member, consented if eligible, and given a baseline assessment. Some participants responded to notices on social media who filled out a brief online screener or contact study staff directly. The matched TAU control participants were selected from callers to CIC in the same time period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Coaching + VA-CRAFT | The interventionist provided a telephone-guided coaching intervention with the aid of a web-based program, VA-CRAFT, developed by the Co-Investigators for concerned significant others (CSOs). The VA-CRAFT program, based on the original Community Reinforcement and Family Training (CRAFT) program for substance misuse has 8 modules: 1) Introduction to CRAFT, 2) Overview of CRAFT, 3) Getting Started with CRAFT: Safety Planning, 4) Understanding substance abuse, 5) How to respond to substance abuse, 6) How to rebuild your life together, 7) How to help someone consider treatment, 8) Wrapping up. The goals of the intervention include helping the CSO understand triggers and long-term reinforcement of substance misuse, ignoring unhealthy behaviors and rewarding healthy behaviors, getting support, and encouraging the Veteran to enter mental health treatment for substance abuse. After viewing each of the VA-CRAFT web-based modules, the interventionist reviewed and personalized the material with the CSO via a telephone conversation. The intervention was flexible within the following framework: 1) 8 to 12, 30-45 min. telephone sessions, every 2-3 weeks, and 2) between 4 and 6 months. |
| FG001 | Treatment as Usual (TAU) Coaching | The treatment as usual coaching (TAU) seeks to empower, motivate, educate, and improved the concerned significant others' (CSOs') listening and communication skills with the goal of enhancing the veteran's intrinsic motivation for care. It draws from self-determination theory and emphasizes humans' underlying need for autonomy to maximize intrinsic motivation. CSOs were encouraged to reduce their pressure on the veteran to seek care and to engage in more positive activities of interest to both. CSOs were coached to listen for concerns expressed by the veteran, such as complaints about mood, anxiety, or the future (11, 12). CSOs were also encouraged to use an "autonomy-supportive" style of communication, which means offering to help the veteran but stating that it is understood that the offer is subject to the veteran welcoming this assistance. Coaching includes behavioral rehearsal to enhance the learning of these skills. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Coaching + VA-CRAFT | The interventionist provided a telephone-guided coaching intervention with the aid of a web-based program, VA-CRAFT, developed by the Co-Investigators for concerned significant others (CSOs). The VA-CRAFT program, based on the original Community Reinforcement and Family Training (CRAFT) program for substance misuse has 8 modules: 1) Introduction to CRAFT, 2) Overview of CRAFT, 3) Getting Started with CRAFT: Safety Planning, 4) Understanding substance abuse, 5) How to respond to substance abuse, 6) How to rebuild your life together, 7) How to help someone consider treatment, 8) Wrapping up. The goals of the intervention include helping the CSO understand triggers and long-term reinforcement of substance misuse, ignoring unhealthy behaviors and rewarding healthy behaviors, getting support, and encouraging the Veteran to enter mental health treatment for substance abuse. After viewing each of the VA-CRAFT web-based modules, the interventionist reviewed and personalized the material with the CSO via a telephone conversation. The intervention was flexible within the following framework: 1) 8 to 12, 30-45 min. telephone sessions, every 2-3 weeks, and 2) between 4 and 6 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Measure Analysis Population Description: Age reported of caller participant (CSO) reported for Coaching + VA CRAFT group only. Age not assessed for TAU Coaching group (usual care). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Veteran's Engaged in Mental Health Care | Veteran's mental health care engagement was assessed from CSO participants' report. | Posted | Count of Participants | Participants | At any point during study involvement, up to 1 year after enrollment |
|
The investigators assessed for adverse events for the 1 year duration of participation for every participant in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Coaching + VA CRAFT | Telephone coaching along with web-based CRAFT course Coaching: Telephone coaching was provided in a series of telephone based sessions with CSO participants |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven L. Sayers | CMC VA Medical Center | (215) 823-5196 | steven.sayers@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 8, 2015 | Mar 10, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 26, 2016 | Feb 10, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D019973 | Alcohol-Related Disorders |
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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.
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| Background |
| 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. |
| 20513681 | Background | 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. |
| 24839077 | Background | 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. |
| 16157233 | Background | 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. |
| 30328689 | Background | 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. |
| 25219288 | Background | 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. |
| 16461451 | Background | 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. |
| 11419236 | Background | 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. |
| 33167815 | Background | 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. |
| 23580022 | Background | Meyers RJ, Roozen HG, Smith JE. The community reinforcement approach: an update of the evidence. Alcohol Res Health. 2011;33(4):380-8. |
| 20626372 | Background | 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. |
| 21545667 | Background | 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. |
| 20873894 | Background | 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. |
| 15612844 | Background | 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. |
| 31621884 | Background | 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. |
| 7722987 | Background | 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. |
| Background | 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. |
| 9203116 | 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. |
| 9881538 | Background | 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. |
| 11556941 | Background | 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. |
| 16377369 | Background | 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. |
| 16423122 | Background | 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. |
| 14645769 | Background | 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. |
| 16050884 | Background | 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. |
| 21135026 | Background | 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. |
| Background | 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. |
| Lost to Follow-up |
|
| BG001 | Treatment as Usual (TAU) Coaching | The treatment as usual coaching (TAU) seeks to empower, motivate, educate, and improved the concerned significant others' (CSOs') listening and communication skills with the goal of enhancing the veteran's intrinsic motivation for care. It draws from self-determination theory and emphasizes humans' underlying need for autonomy to maximize intrinsic motivation. CSOs were encouraged to reduce their pressure on the veteran to seek care and to engage in more positive activities of interest to both. CSOs were coached to listen for concerns expressed by the veteran, such as complaints about mood, anxiety, or the future (11, 12). CSOs were also encouraged to use an "autonomy-supportive" style of communication, which means offering to help the veteran but stating that it is understood that the offer is subject to the veteran welcoming this assistance. Coaching includes behavioral rehearsal to enhance the learning of these skills. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race was not assessed for CSO's included in the TAU matched comparison group since race was not collected as part of usual clinical operations. | Race was not collected as part of TAU data collection for clinical purposes. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Veteran's engagement in MH Care at Baseline | As reported by CSO, the engagement of Veteran in MH Care at the baseline assessment, also reflecting that the Veteran was not engaged in MH care within the previous 6 months prior to the onset of study period. | Count of Participants | Participants |
|
| Relationship | Relationship of CSO to the Veteran: spouse/intimate other, sibling, parent | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Treatment as Usual | Treatment as usual matched comparison Coaching: Telephone coaching was provided in a series of telephone based sessions with CSO participants | 0 | 26 | 0 | 26 | 0 | 26 |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Parent |
|