Integrating Combined Therapies for Persons With Co-occurring Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Decrease from baseline in alcohol use (90-day Timeline Follow Back (TLFB) at 4-months and at 7-months
研究概览
简要总结
The purpose of this study is to assess the effectiveness and implementability of ICT for co-occurring alcohol use and mental health disorders within community addiction treatment, as delivered by routine community addiction clinicians.
详细描述
The proposed study will evaluate the effectiveness and implementability of a manual-guided integrated psychosocial treatment, Integrating Combined Therapies (ICT). ICT is an adaptation of the Combined Behavioral Intervention (CBI) from NIAAA Project COMBINE, and expands CBI's indication for alcohol problems to extend to drug use and the most common psychiatric problems in addiction treatment. ICT is designed to be transferable to routine care settings and for delivery by the existing workforce. Findings from a 2014 study provide a signal for ICT effectiveness and implementation.
We intend to randomly assign 76 eligible patients in outpatient addiction treatment to ICT adapted standard care (ICT+SC) versus standard care only (SC). There are 2 specific aims for this study:
Aim 1: Relative to standard care alone, to evaluate if patients receiving ICT have more significant reductions in alcohol use and severity as measured by the 90-day Timeline Follow Back (TLFB), Addiction Severity Index (ASI), and Short Inventory of Problems (SIP).
Aim 2: Relative to standard care alone, to evaluate if patients receiving ICT have more significant reductions in psychiatric symptom severity, as measured by the Brief Symptom Inventory (BSI) adn the ASI psychiatric severity composite.
This study involves a two-group repeated measure design. This study is a randomized controlled trial. The investigators plan to examine the outcomes associated with ICT versus standard care among patients receiving outpatient addiction treatment services. The investigators will employ assessments at baseline, four-month follow-up, and seven-month follow-up. Eligible participants will be randomly assigned to ICT therapy (plus standard care) or standard care, and all will be followed for the research assessments regardless of whether they drop out of treatment early (whenever possible).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •At least 18 years old;
- •Evaluated and admitted to outpatient addiction treatment services at RMHS Evergreen program and meets criteria for any alcohol or substance use disorder;
- •Screened positive for an alcohol problem on the Alcohol Use Disorders Identification Test (AUDIT) (score of 8 or higher) (screening instrument);
- •Screened positive for a mental health problem on the Modified MINI Screen (MMS) (score of 6 or higher) (screening instrument);
- •Diagnoses confirmed by SCID (diagnostic interview); AND
- •Willing and able to provide informed consent.
排除标准
- •They have acute psychotic symptoms and are not appropriately connected with mental health services;
- •They have had a psychiatric hospitalization or suicide attempt within the past month (however, if the hospitalization or attempt was directly related to substance intoxication or detoxification and the person is currently stable, they are eligible); OR
- •They have unstable medical or legal situations that would make participation for the full duration of the study highly unlikely.
研究组 & 干预措施
Integrating Combined Therapies
Integrating Combined Therapies (ICT) is a 10-session, manual-guided individual therapy. ICT has three phases designed to address substance use, psychiatric problems and their interactions. MET is the first phase (2 sessions) and is focused on assessment, feedback and securing motivation to address problems and take steps. CBT is the second phase (5 sessions) and incorporates patient education and functional analysis, develops coping skills, teaches methods to challenge beliefs, and activates alternative behaviors. TSF (3 sessions) is focused on maintaining recovery and engaging in community-based recovery activities. Although ICT has core components, its application is flexible to accommodate the unique needs and problems of individual patients (and their comorbidities).
干预措施: Integrating Combined Therapies (Behavioral)
Standard Care
Standard Care (SC) is the typical outpatient treatment that the patient would receive ordinarily at the identified addiction treatment program. SC service operates using the American Society of Addiction Medicine criteria (9 hours per week); group and individual sessions focused on motivation to address substance use, education about the consequences of substance use on major life areas, education about the disease concept and brain changes associated with addiction, exposure to information about social and family relationships and recovery, and relapse prevention skills.
干预措施: Standard Care (Behavioral)
结局指标
主要结局
Decrease from baseline in alcohol use (90-day Timeline Follow Back (TLFB) at 4-months and at 7-months
时间窗: Baseline, 4-month, 7-month follow-up
Decrease from baseline in alcohol use severity (ASI; alcohol severity composite) at 4-months and at 7-months
时间窗: Baseline, 4-month, 7-month follow-up
Decrease from baseline in alcohol use severity (Short Inventory of Problems (SIP)) at 4-months and at 7-months
时间窗: Baseline, 4-month, 7-month follow-up
Decrease from baseline in psychiatric symptom severity (ASI; Psychiatric Severity Composite) at 4-months and at 7-months
时间窗: Baseline, 4-month, 7-month follow-up
Decrease in psychiatric symptom severity (Brief Symptom Inventory (BSI)) at 4-months and 7-months
时间窗: Baseline, 4-month, 7-month follow-up
次要结局
- Decrease from baseline in drug use (90-day TLFB) at 4-months and at 7-months(Baseline, 4-month, 7-month follow-up)
- Decrease from baseline in positive toxicology screen (urine drug screen) at 4-months and at 7-months(Baseline, 4-month, 7-month follow-up)
- Decrease from baseline in drug use severity (ASI; Drug Severity Composite) at 4-months and 7-months(Baseline, 4-month, 7-month follow-up)
研究者
Mark McGovern
Study Principal Investigator
Stanford University