F-CaST for Individuals With Substance Use Disorder

NCT05647863 | Completed

• 1 other identifier: 0001484-4
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Substance Use Disorders

Keywords

Rehabilitation compliance; Executive functions; Sensory modulation dysfunction

Outcome Measures

Primary Outcomes (4)

• Change The Canadian Occupational Performance Measure (COPM)

  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.

  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

• Length of stay in Therapeutic Community

  Length of stay (days) residing in Therapeutic Community. Longer time spent in the TC is better.

  At T4 ( three months later after follow-up) or earlier (when they leave the TC)

• Change in Performance in the Therapeutic Community

  Participant performance in the Therapeutic Community will be based on the community counselor's evaluation. Better performance is better

  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).

• Change in number of times coming late for scheduled appointments

  Number of times coming late for scheduled appointments. Less times of coming late is better.

  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 (11)

• 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)]

• 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)]

• 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)]

• 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)]

• 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)]

Other Outcomes (3)

• Montreal Cognitive Assessment

  T1- pre-intervention

• The Adult ADHD Self-Report Scale-Version 1.1

  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 Satisfaction from the intervention questionnaire

  Post intervention (T2, which is 8-9 weeks after T1)

Study Arms (2)

F-CaST

EXPERIMENTAL

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.

Other: Functional Cognitive and Sensory Treatment (F-CaST)

Standard Care

NO INTERVENTION

Standard care at the therapeutic community for SUD.

Interventions

Functional Cognitive and Sensory Treatment (F-CaST) OTHER

F-CaST, a client-centered care, is a functional cognitive sensory intervention focusing on improving Executive Function (EF) and sensory modulation impairments using a modification of the Functional and Cognitive Occupational Therapy Treatment.

Also known as: Cognitive sensory occupational therapy

F-CaST

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Relapsing substance use in the TC

Sponsors & Collaborators

• Tel Aviv University: lead

Study Sites (1)

Malkishua

Afula, Israel

Location

Related Publications (1)

• Assayag N, Bar-Shalita T, Rand D. The Functional-Cognitive and Sensory Treatment (F-CaST) to improve rehabilitation outcomes of individuals with substance use disorder: a study protocol for a mixed-method randomized controlled trial. Addict Sci Clin Pract. 2024 Apr 9;19(1):28. doi: 10.1186/s13722-024-00449-7.

  PMID: 38594737 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Naama Assayag, Dr.

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors in the RCT will be blind to group allocation
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial with an experimental group and a control group

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: December 13, 2022
• Study Start: November 25, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)