Improving Rehabilitation Compliance and Treatment Duration by Treating Executive Function and Sensory Modulation Deficits in Individuals With Substance Use Disorder: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change in number of times coming late for scheduled appointments
研究概览
简要总结
Examining the effectiveness of the F-CaST based on a controlled randomized trial in patients with SUD residing in a therapeutic community.
详细描述
Background and Aims: Substance use disorder (SUD), an urgent public health concern, is a chronic relapsing brain disorder caused by psychoactive substances, characterized by cognitive, behavioral, and physiological symptoms, severely impacting every life domain. Repeated substance use leads to impairments in higher cognitive abilities, termed executive functions (EF), and leads to SUD chronicity. Furthermore, EF deficits are associated with difficulties in sensory processing, severely limiting daily functions and with reported high incidence in SUD. However, to date both are not addressed therapeutically. This translational study aims to enhance rehabilitation success in patients with SUD residing in a therapeutic community (TC) by employing sensory and EF strategies utilizing the Functional Cognitive and Sensory Treatment (F-CaST), an innovative personalized therapy.
Methods: A qualitative study will be nested in a single-blind, controlled randomized trial, comparing two groups: (i) Experimental group- F-CaST - in which therapy is individually tailored for successful task performance and where the focus is on strategies for improving sensory and EF deficits and (ii) Control group - Standard Care - the typical treatment given in the therapeutic community. Measurement will be conducted by assessors blind to group allocation at 4 time points: T1- pre-intervention; T2- post-intervention; T3- at a 1-month follow-up; and T4- at a 3-month follow-up.
Population: Forty-eight adults diagnosed with SUD, aged 18-45 years, with no significant cognitive deficits, and residing in a TC for SUD.
Tools: Both objective and subjective measures to evaluate TC performance will be applied. Additionally, interviews will be conducted to provide a deeper understanding of the perceived performance and difficulties.
Expected Results: F-CaST will lead to improved rehabilitation success and treatment duration, better compliance with TC requirements, and greater satisfaction, compared to control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors in the RCT will be blind to group allocation
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed by a psychiatrist and meeting the DSM-V diagnostic criteria for severe SUD
- •Admitted to the therapeutic community (TC) for full-length SUD rehabilitation and with no more than 3 previous rehabilitation trials in this TC
- •Abstained from drugs and alcohol for at least 14 days (verifying minimum withdrawal effects); and no more than 21 days of TC residency (to ensure familiarization with the facility)
- •Without a significant cognitive deficit [the Montreal Cognitive Assessment (MoCA)≥19/30 points) and adequate language skills
排除标准
- •Relapsing substance use in the TC
研究组 & 干预措施
F-CaST
The experimental group who will receive the Functional Cognitive and Sensory Treatment (F-CaST)- in which therapy is individually tailored for successful task performance and where the focus is on strategies for improving sensory and EF deficits.
干预措施: Functional Cognitive and Sensory Treatment (F-CaST) (Other)
Standard Care
Standard care at the therapeutic community for SUD.
结局指标
主要结局
Change in number of times coming late for scheduled appointments
时间窗: Change in number of times coming late for scheduled appointments between pre (T1-week 0) - to post (T2- post-intervention 8-9 weeks later) to T3 (follow-up- one month later) and T4 (follow-up- three months later).
Number of times coming late for scheduled appointments. Less times of coming late is better.
Change The Canadian Occupational Performance Measure (COPM)
时间窗: Change in The Canadian Occupational Performance Measure between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), to T3 (follow-up- one month later) and T4 (follow-up- three months later). Higher scores indicate better outcomes
The Canadian Occupational Performance Measure (COPM) is a client-centered outcome measure for individuals to identify and prioritize everyday issues that restrict their participation in everyday living. Participants will define three goals, and rate their current performance \& satisfaction for each goal using a 10-point scale. Higher scores indicate better outcomes.
Length of stay in Therapeutic Community
时间窗: At T4 ( three months later after follow-up) or earlier (when they leave the TC)
Length of stay (days) residing in Therapeutic Community. Longer time spent in the TC is better.
Change in Performance in the Therapeutic Community
时间窗: Change in Performance in the Therapeutic Community between pre (T1-week 0) - to post (T2- post-intervention 8-9 weeks later) to T3 (follow-up- one month later) and T4 (follow-up- three months later).
Participant performance in the Therapeutic Community will be based on the community counselor's evaluation. Better performance is better
次要结局
- Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)(Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)])
- The Self-Regulation Skills Interview(Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)])
- Satisfaction with Life Scale(Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)])
- Computerized cognitive assessment battery (CANTAB)(Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)])
- Color Trails Test (CTT)(Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)])
- The Pain Sensitivity Questionnaire(Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)])
- The New General Self-Efficacy Scale(Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)])
- The Sensory Responsiveness Questionnaire-Intensity Scale(Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)])
- In-depth semi-structured interview(Pre (T1-week 0), T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later))
- The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) - 12 item version(Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later))
- Four Item Tablet Test (4ITT)(Change between pre (T1-week 0) to T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)])
研究者
Tami Bar-Shalita
Principal Investigator
Tel Aviv University