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F-CaST for Individuals With Substance Use Disorder

T

Tel Aviv University

Status

Completed

Conditions

Substance Use Disorders

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05647863
0001484-4

Details and patient eligibility

About

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

Full 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.

Enrollment

46 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

46 participants in 2 patient groups

F-CaST
Experimental group
Description:
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.
Treatment:
Other: Functional Cognitive and Sensory Treatment (F-CaST)
Standard Care
No Intervention group
Description:
Standard care at the therapeutic community for SUD.

Trial contacts and locations

1

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Central trial contact

Debbie Rand, Prof.; Tami Bar-Shalita, Dr.

Data sourced from clinicaltrials.gov

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