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

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ClinicalTrials.gov Identifier: NCT06174714
Recruitment Status : Not yet recruiting
First Posted : December 18, 2023
Last Update Posted : December 18, 2023
Sponsor:
Information provided by (Responsible Party):
Kristiana Siste, Indonesia University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Substance Use Disorders Behavioral: Indonesia Substance Use Reduction for Female Therapy (Indo-SURFT) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Indo-SURFT in Reducing Addictive Substance Use in Women With Substance Use Disorders: a Pilot Study
Estimated Study Start Date : December 2023
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : August 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: MI and Indo-SURFT
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)
4 weeks of motivational interviewing/motivational enhancement therapy (MI) followed by 8 weeks cognitive behavioral therapy (CBT) using Indo-SURFT module.


Outcome Measures
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Primary Outcome Measures :
  1. Abstinence from Substance Use [ Time Frame: post-intervention (week 13) ]
    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.

  2. Decrease in Addiction Severity [ Time Frame: pre-intervention (week 0), and post-intervention (week 13) ]
    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.

  3. Improvement in Motivation to Change [ Time Frame: pre-intervention (week 0), and post-intervention (week 13) ]
    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.

  4. Improvement in Substance Craving [ Time Frame: pre-intervention (week 0), and post-intervention (week 13) ]
    Visual Analog Scale (VAS), measuring substance craving severity. Range 0 (no craving) - 100 (severe craving). A lower score indicates a better outcome.


Secondary Outcome Measures :
  1. Improvement in Psychological Distress [ Time Frame: pre-intervention (week 0), and post-intervention (week 13) ]
    Self-Report Questionnaire-20 (SRQ-20), measuring non-specific psychological distress. Score range 0-20; Scores >10 classified as mental distress. A lower score indicates a better outcome.

  2. Improvement in Social Performance [ Time Frame: pre-intervention (week 0), and post-intervention (week 13) ]
    Personal and Social Performance (PSP), measuring social function. A lower score indicates a better outcome.

  3. Improvement in Quality of Life [ Time Frame: pre-intervention (week 0), and post-intervention (week 13) ]
    World Health Organization Quality of Life (WHOQOL), measuring individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. A higher score indicates a better outcome.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • subjects with severe mental disorder or intellectual disability
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Kristiana Siste, Dr. dr. Kristiana Siste, SpKJ(K) - Head of Department of Psychiatry, Faculty of Medicine, Indonesia University, Indonesia University
ClinicalTrials.gov Identifier: NCT06174714    
Other Study ID Numbers: KET-735-2023
First Posted: December 18, 2023    Key Record Dates
Last Update Posted: December 18, 2023
Last Verified: December 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders