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

Substance Use Disorders Clinical Trial

— Indo-SURFT  

Official title:

Effectiveness of Indo-SURFT in Reducing Addictive Substance Use in Women With Substance Use Disorders: a Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06174714
• Other study ID #: KET-735-2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: August 2024

Study information

• Verified date: December 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	Improvement in Psychological Distress	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.	pre-intervention (week 0), and post-intervention (week 13)
Secondary	Improvement in Social Performance	Personal and Social Performance (PSP), measuring social function. A lower score indicates a better outcome.	pre-intervention (week 0), and post-intervention (week 13)
Secondary	Improvement in Quality of Life	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.	pre-intervention (week 0), and post-intervention (week 13)