Substance Use DisordersIndo-SURFTNCT06174714
Effectiveness of Indo-SURFT in Reducing Addictive Substance Use in Women With Substance Use Disorders
A study testing Indonesia Substance Use Reduction for Female Therapy (Indo-SURFT) in people with Substance Use Disorders, run by Universitas Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 59 years, women only
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Indonesia Substance Use Reduction for Female Therapy (Indo-SURFT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women aged 18-59 years old
- diagnosed with substance use disorders based on DSM-V or ICD-10
Who cannot join
- subjects with severe mental disorder or intellectual disability
About this study
Official title: Effectiveness of Indo-SURFT in Reducing Addictive Substance Use in Women With Substance Use Disorders: a Pilot Study
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
- Being tested
- Indonesia Substance Use Reduction for Female Therapy (Indo-SURFT)
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indonesia Substance Use Reduction for Female Therapy (Indo-SURFT)Behavioural
4 weeks of motivational interviewing/motivational enhancement therapy (MI) followed by 8 weeks cognitive behavioral therapy (CBT) using Indo-SURFT module.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Indonesia Substance Use Reduction for Female Therapy (Indo-SURFT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: pre-intervention (week 0), and post-intervention (week 13)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: pre-intervention (week 0), and post-intervention (week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study startAug 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristiana Siste, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174714
- Sponsor's protocol ID
- KET-735-2023
- Acronym
- Indo-SURFT
- Status last verified
- Jul 2024
- First submitted
- 6 Dec 2023
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Indo-SURFT in Reducing Addictive Substance Use in Women With Substance Use Disorders: a Pilot Study
- ClinicalTrials.gov ID
- NCT06174714
- Acronym / sponsor ID
- Indo-SURFT / KET-735-2023
- Conditions
- Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MI and Indo-SURFT | Experimental | Behavioral: Indonesia Substance Use Reduction for Female Therapy (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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- women aged 18-59 years old
- diagnosed with substance use disorders based on DSM-V or ICD-10
Key exclusion criteria (1 listed)
- subjects with severe mental disorder or intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | MI and Indo-SURFT |
Primary outcome
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.
3 secondary outcomes
Improvement in Psychological Distress
Time frame: pre-intervention (week 0), and post-intervention (week 13)
Improvement in Social Performance
Time frame: pre-intervention (week 0), and post-intervention (week 13)
Improvement in Quality of Life
Time frame: pre-intervention (week 0), and post-intervention (week 13)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Indonesia Substance Use Reduction for Female Therapy (Indo-SURFT) in people with Substance Use Disorders, run by Universitas Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abstinence from Substance Use (time frame: post-intervention (week 13)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.