Clinical trial NCT05647863: F-CaST for Individuals With Substance Use Disorder
Official title: Improving Rehabilitation Compliance and Treatment Duration by Treating Executive Function and Sensory Modulation Deficits in Individuals With Substance Use Disorder: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Keywords: Rehabilitation compliance
Executive functions
Sensory modulation dysfunction
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 46
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with an experimental group and a control group
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Examining the effectiveness of the F-CaST based on a controlled randomized trial in patients with SUD residing in a therapeutic community.

Detailed description: 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.

Eligibility criteria: Inclusion criteria:

* 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

Exclusion Criteria:

* Relapsing substance use in the TC

Primary outcomes:
measure: Change The Canadian Occupational Performance Measure (COPM)
timeFrame: 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
measure: Length of stay in Therapeutic Community
timeFrame: At T4 ( three months later after follow-up) or earlier (when they leave the TC)
measure: Change in Performance in the Therapeutic Community
timeFrame: 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).
measure: Change in number of times coming late for scheduled appointments
timeFrame: 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).
Secondary outcomes:
measure: Four Item Tablet Test (4ITT)
timeFrame: 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)]
measure: Color Trails Test (CTT)
timeFrame: 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)]
measure: Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)
timeFrame: 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)]
measure: Computerized cognitive assessment battery (CANTAB)
timeFrame: 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)]
measure: The Self-Regulation Skills Interview
timeFrame: 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)]
measure: The Sensory Responsiveness Questionnaire-Intensity Scale
timeFrame: 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)]
measure: The Pain Sensitivity Questionnaire
timeFrame: 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)]
measure: The New General Self-Efficacy Scale
timeFrame: 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)]
measure: Satisfaction with Life Scale
timeFrame: 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)]
measure: In-depth semi-structured interview
timeFrame: Pre (T1-week 0), T2 (post-intervention 8-9 weeks later), T3 (follow-up- one month later) and T4 (follow-up- three months later)
measure: The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) - 12 item version
timeFrame: 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)
Other outcomes:
measure: Montreal Cognitive Assessment
timeFrame: T1- pre-intervention
measure: The Adult ADHD Self-Report Scale-Version 1.1
timeFrame: 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)]
measure: The Satisfaction from the intervention questionnaire
timeFrame: Post intervention (T2, which is 8-9 weeks after T1)
Locations:
city: Afula
country: Israel
facility: Malkishua
Study officials:
affiliation: Tel Aviv University
name: Naama Assayag, Dr.
role: PRINCIPAL_INVESTIGATOR
References: