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

Study Overview
=================
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.

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

Conditions
-----------------
Substance Use Disorders

Intervention / Treatment
-----------------
* Behavioral: Indonesia Substance Use Reduction for Female Therapy (Indo-SURFT)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MI and Indo-SURFT<br>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)<br>* 4 weeks of motivational interviewing/motivational enhancement therapy (MI) followed by 8 weeks cognitive behavioral therapy (CBT) using Indo-SURFT module.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) |