A Brief Values Intervention to Support Veterans in Early Buprenorphine Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of participants recruited
研究概览
简要总结
The US Veteran community continues to feel the impact of the overdose crisis, and opioid use disorder (OUD) diagnoses among Veterans continue to rise. Medication treatment (e.g., buprenorphine, methadone, naltrexone) helps prevent relapse and reduce overdose risk, but does not help with the psychological, social, and functional challenges of early recovery. Therapies that focus on interpersonal functioning and community integration may help improve quality of life during this high-risk period. This research project will create and test a brief, values-based treatment to help Veterans improve their interpersonal functioning and community integration during early treatment. This study will have three phases. Phase 1 will involve the development of the treatment and adaptation using interviews with Veterans and VA Providers. Phase 2 will test the treatment with a group of 10 Veterans to make sure the treatment can be delivered as intended, and to make changes to the treatment or study procedures based on Veteran feedback. Finally, Phase 3 will test the treatment compared to usual treatment in a pilot randomized controlled trial with a group of 40 Veterans. This final phase will provide additional information about Veterans' experience of the treatment and study procedures and the preliminary effects of the treatment on quality of life and related outcomes.
详细描述
The current project will develop and pilot a brief, manualized intervention for improving Veterans' interpersonal functioning, community reintegration, and quality of life during early medication treatment for OUD. The research outlined in the current proposal will yield the necessary information to determine whether a fully powered randomized controlled trial of the intervention is warranted through completion of work outlined in Stages 1a (Phases 1 & 2) and 1b (Phase 3) of the NIH Stage Model for Behavioral Intervention Development.
Update 6 2026: Based on recruitment rates for the second phase of this acceptability and feasibility project as well as broader trends in the addiction and treatment development research literature, modifications to Phase 3 included: 1. Expanding "time since medication initiation" to 12 months (from 3 months); and 2. Replacement of the planned Pilot RCT with a second, larger open trial.
Phase 1: Initial Development (13 months): In Phase 1, the initial treatment manual will be developed and revised using feedback from key stakeholders. After semi-structured stakeholder interview guides are developed in parallel with the initial manual, qualitative data from interviews with Veterans (n = 18) and VA providers (n = 16) will guide manual adaptations.
Phase 2: Open Pilot (14 months): The manual development process will continue via an open pilot trial with n = 10 Veterans in early buprenorphine treatment, with recruitment to begin in the second month of the first quarter of Year 2. This initial field test will allow for the further refinement of the treatment manual and study protocol based on Veteran feedback and the experience of conducting the trial and delivering the intervention. Phase 2 will also involve the development of treatment adherence measures and training procedures for study therapists and adherence raters.
Phase 3: Pilot Feasibility Trial (33 months): The final phase of the proposed research will involve a Stage 1b pilot trial. A sample of n = 40 Veterans will receive the finalized intervention. This pilot will provide an opportunity to evaluate the refined intervention and assessment procedures and to assess feasibility and acceptability of the intervention. As an exploratory aim, this phase will also provide preliminary data for intervention effects on primary outcomes of interpersonal functioning, community reintegration, and quality of life, as well as secondary outcomes of interest (e.g., substance use) and candidate process measures. Results of this phase will be critical for informing the feasibility of a subsequent, fully powered RCT of the resulting intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
In Phase 3, assessment sessions will be conducted by an independent assessor.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets current Diagnostic and Statistical Manual - 5th Edition criteria for moderate to severe opioid use disorder
- •Phase 2: Within 12 weeks of initiating buprenorphine, methadone, or naltrexone treatment for opioid use disorder following at least 2 months without treatment; Phase 3: Within 12 weeks of initiating buprenorphine, methadone, or naltrexone treatment for opioid use disorder following at least 2 months without treatment
- •Competent to provide written informed consent
排除标准
- •Evidence of active psychosis or mania
- •Suicidality requiring inpatient hospitalization
- •Active substance use requiring detoxification
- •Cognitive impairment that would interfere with study participation
研究组 & 干预措施
Open Pilot
In Phase 2, all Veterans will receive the active treatment.
干预措施: Brief, values based intervention for early buprenorphine treatment (Behavioral)
Active Condition
In Phase 3 (Pilot RCT), all Veterans will be assigned to the active treatment.
干预措施: Brief, values based intervention for early buprenorphine treatment (Behavioral)
结局指标
主要结局
Number of participants recruited
时间窗: Through study completion, up to three years
Feasibility will be assessed in Phase 3 using an a priori benchmark of at least n=2 participants recruited on average per month.
Number of treatment sessions attended
时间窗: 6 weeks
Feasibility will be assessed in Phase 3 using an a priori benchmark of at least 3 of the 4 sessions attended by 50% or more of the study participants. The six week time frame provides some flexibility for scheduling the 4 weekly study sessions.
Therapist Adherence
时间窗: 6 weeks
Therapist adherence and competence scales will be developed in Phase 2 and used to assess Therapist Adherence to the treatment as a feasibility measure using an a priori benchmark of 80%. The scale will be adapted from a rating system designed to assess use of broadly defined ACT-consistent therapeutic strategies, appropriate use of specific ACT techniques from a given manual, and the absence of techniques that are inconsistent with ACT-based interventions. The structure of the overall scale will be retained, such that each item is assessed for frequency and extensiveness on a scale of 1 (not at all) to 5 (extensively).
Client Satisfaction Questionnaire 8-item (CSQ-8)
时间窗: 6 weeks
The Client Satisfaction Questionnaire 8-item (CSQ-8) is a commonly used 8-item measure which has been used with similar participant samples to assess treatment satisfaction. Scores range from 8 to 32, with higher scores reflecting higher satisfaction. It will be used in Phase 3 as an additional measure of acceptability for the intervention, using an a priori benchmark of average satisfaction scores at or above 24.
Expectancy item of the Credibility/Expectancy Questionnaire (CEQ)
时间窗: 1 week
The Credibility/Expectancy Questionnaire (CEQ) is a 6-item self-report measure which will be administered following the first intervention session. Expectancy will be measured using item 4, the most common index for expectancy. This item is rated on a scale from 0% to 100% with higher percentages reflecting higher anticipated improvement. As an indicator of acceptability of the intervention in Phase 3, the investigators will use a priori benchmark of average expectancy at or above 50%. improvement expected.
Credibility subscale of the Credibility/Expectancy Questionnaire (CEQ)
时间窗: 1 Week
The Credibility/Expectancy Questionnaire (CEQ) is a 6-item self-report measure which will be administered following the first intervention session. The three item Credibility subscale produces scores ranging from 3 to 27, with higher scores reflecting higher credibility. As an indicator of acceptability of the intervention in Phase 3, the investigators will use an a priori benchmark of average credibility at or above 15, reflecting a "somewhat" credible rating.
次要结局
- Change in the Social Adjustment Scale-Self Report(Baseline, End of Treatment (6 weeks), 3-month follow-up, and 6-month follow-up)
- Change in the Medical Outcomes Study (MOS) Social Support Survey(Baseline, End of Treatment (6 weeks), 3-month follow-up, and 6-month follow-up)
- Change in days of opioid use on the Addiction Severity Index-Lite(Baseline, End of Treatment (6 weeks), 3-month follow-up, and 6-month follow-up)
- Change in the World Health Organization Quality Of Life (WHOQOL)-BREF(Baseline, End of Treatment (6 weeks), 3-month follow-up, and 6-month follow-up)
- Change in medication (buprenorphine, methadone, or naltrexone) appointment attendance(Baseline, End of Treatment (6 weeks), 3-month follow-up, and 6-month follow-up)