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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

Tracking Information
First Submitted Date  ICMJE December 6, 2023
First Posted Date  ICMJE December 18, 2023
Last Update Posted Date December 18, 2023
Estimated Study Start Date  ICMJE December 2023
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2023)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2023)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Indo-SURFT in Reducing Addictive Substance Use in Women With Substance Use Disorders
Official Title  ICMJE Effectiveness of Indo-SURFT in Reducing Addictive Substance Use in Women With Substance Use Disorders: a Pilot Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Substance Use Disorders
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Behavioral: Indonesia Substance Use Reduction for Female Therapy (Indo-SURFT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 13, 2023)		 30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2024
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06174714
Other Study ID Numbers  ICMJE KET-735-2023
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Kristiana Siste, Indonesia University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Indonesia University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Indonesia University
Verification Date December 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP