F-CaST for Individuals With Substance Use Disorder

NCT ID: NCT05647863

Last Updated: 2024-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-25

Study Completion Date

2023-12-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial with an experimental group and a control group
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
Assessors in the RCT will be blind to group allocation

Study Groups

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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.

Group Type EXPERIMENTAL

Functional Cognitive and Sensory Treatment (F-CaST)

Intervention Type 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.

Standard Care

Standard care at the therapeutic community for SUD.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Functional Cognitive and Sensory Treatment (F-CaST)

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.

Intervention Type OTHER

Other Intervention Names

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Cognitive sensory occupational therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Tel Aviv University

OTHER

Sponsor Role lead

Responsible Party

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Tami Bar-Shalita

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Naama Assayag, Dr.

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv University

Locations

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Malkishua

Afula, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 38594737 (View on PubMed)

Other Identifiers

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0001484-4

Identifier Type: -

Identifier Source: org_study_id

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