Effectiveness of Indo-SURFT in Reducing Addictive Substance Use in Women With Substance Use Disorders

NCT06174714 | Not Yet Recruiting

• 1 other identifier: KET-735-2023
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Relapse in women was associated with depression, interpersonal stress, and relationship conflict with others when compared with men. The differences in gender profiles with substance use disorders (SUD) leads to the need for management strategies that are sensitive to each gender. This is a challenge to build a new module that can be applied continuously by collaborating CBT and several other psychosocial interventions, such as motivational enhancement therapy. The investigators compiled Indonesia Substance Use Reduction for Female Therapy (Indo-SURFT). By implementing this module, it is hoped that it can provide short and long term effects and reduce the relapse rate in women with SUD.

Conditions

Substance Use Disorders

Outcome Measures

Primary Outcomes (4)

• Abstinence from Substance Use

  Timeline Follow Back (TLFB): to assess daily use of addictive substances by writing yes/no for 28 days. This data will be collected weekly retrospectively to reduce the risk of recall bias.

  post-intervention (week 13)

• Decrease in Addiction Severity

  Addiction Severity Index (ASI), Indonesia version, measuring several domains: 1) Medical health (n= 11), 2) Employment/ support status (n= 24), 3 \& 4) Drug/ alcohol use (n= 35), 5) Illegal activity/ legal status (n= 32), 6) Family/ social relationships (n= 38) and 7) Psychiatric health (n= 23). Lesser score indicates better outcome.

  pre-intervention (week 0), and post-intervention (week 13)

• Improvement in Motivation to Change

  University of Rhode Island Change Assessment (URICA), measuring motivation to change with 4 domains: 1) pre-contemplation, 2) contemplation, 3) action, and 4) maintenance. A higher score indicates a better outcome.

  pre-intervention (week 0), and post-intervention (week 13)

• Improvement in Substance Craving

  Visual Analog Scale (VAS), measuring substance craving severity. Range 0 (no craving) - 100 (severe craving). A lower score indicates a better outcome.

  pre-intervention (week 0), and post-intervention (week 13)

Secondary Outcomes (3)

• Improvement in Psychological Distress

  pre-intervention (week 0), and post-intervention (week 13)

• Improvement in Social Performance

  pre-intervention (week 0), and post-intervention (week 13)

• Improvement in Quality of Life

  pre-intervention (week 0), and post-intervention (week 13)

Study Arms (1)

MI and Indo-SURFT

EXPERIMENTAL

once a week motivational interviewing/motivational enhancement therapy (MI) for 4 weeks, followed by once a week CBT using Indonesia Substance Use Reduction for Female Therapy (Indo-SURFT) for 8 weeks.

Behavioral: Indonesia Substance Use Reduction for Female Therapy (Indo-SURFT)

Interventions

Indonesia Substance Use Reduction for Female Therapy (Indo-SURFT) BEHAVIORAL

4 weeks of motivational interviewing/motivational enhancement therapy (MI) followed by 8 weeks cognitive behavioral therapy (CBT) using Indo-SURFT module.

MI and Indo-SURFT

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• women aged 18-59 years old
• diagnosed with substance use disorders based on DSM-V or ICD-10

You may not qualify if:

• subjects with severe mental disorder or intellectual disability

Sponsors & Collaborators

• Indonesia University: lead

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. dr. Kristiana Siste, SpKJ(K) - Head of Department of Psychiatry, Faculty of Medicine, Indonesia University

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 18, 2023
• Study Start: August 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: July 11, 2024

Record last verified: 2024-07