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

July 10, 2024 updated by: Kristiana Siste, Indonesia University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
post-intervention (week 13)
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.
pre-intervention (week 0), and post-intervention (week 13)
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.
pre-intervention (week 0), and post-intervention (week 13)
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.
pre-intervention (week 0), and post-intervention (week 13)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
pre-intervention (week 0), and post-intervention (week 13)
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.
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KET-735-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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