Back to resultsWomen's Opioid Treatment Follow-up Study
Primary Purpose
Opioid Use Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gender-specific digital intervention (GSDI)
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Use Disorder
Eligibility Criteria
Inclusion Criteria: age 18 years of age or older current opioid use disorder diagnosis have a smartphone initiated medication treatment for opioid use disorder in the past 10 days, able to provide informed consent Exclusion Criteria: an acute psychiatric or medical condition, or cognitive impairment, that would impair the ability to complete study procedures admitted to their current treatment episode on an involuntary status
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Gender-specific digital intervention plus treatment as usual (GSDI+TAU)
Treatment as usual (TAU)
Arm Description
GSDI + TAU includes the addition of a gender-specific digital intervention (GSDI) to treatment as usual. The GSDI has a web-based component and a mobile component. The web-based portion of the GSDI includes: (1) gender-specific psychoeducation on substance use disorders, (2) specific education on opioid use disorder, including information about medication treatment for opioid use disorder, and (3) information on relapse-prevention skills. Participants complete the web-based portion immediately after completing baseline assessments. The mobile component includes three parts: (1) weekly self-report surveys of opioid and other substance use and medication adherence, (2) weekly skills-practice exercises, and (3) daily motivational messages encouraging self-care. Participants engage with the mobile component after completing the web-based portion until the end of the study (12 weeks).
TAU for opioid use disorder consists of a mix of medication treatment and individual and group therapy services across various levels of care: inpatient, residential, and outpatient. Residential treatment is for adults who have completed detoxification and require additional treatment in a structured environment. Inpatient treatment includes short-term care and detoxification treatment and incorporates a combination of group, family, and individual therapy targeted at medical stabilization, reducing the severity of the patient's symptoms, and providing resources and ongoing support to prevent relapse. Outpatient treatment is focused on comprehensive evaluation and stabilization.
Outcomes
Primary Outcome Measures
Client Satisfaction Questionnaire
The Client Satisfaction Questionnaire (CSQ) assesses participant satisfaction of the digital intervention. The original CSQ has 8 items and we have added an additional 8 items to gather satisfaction with specific aspects of the digital intervention.
System Usability Scale
The System Usability Scale (SUS) is a 10-item questionnaire with five response options for respondents from Strongly agree to Strongly disagree. The SUS is used to measure usability of products and services, including hardware, software, mobile devices, websites, and applications.
Engagement metrics
Engagement data will be retrieved from MetricWire including number of logins, number of completed check-ins and skills practices, and time spent on each of these activities. Time spent on the web-based portion of the GSDI will be calculated from REDCap.
Qualitative Exit Interview
Qualitative user experience exit interviews will be coded and analyzed using thematic analysis methodology to identify common themes.
Secondary Outcome Measures
Timeline Followback
The Timeline Followback calendar method will be used to collect self-report data on medication for opioid use disorder adherence.
Full Information
NCT ID
NCT05776966
First Posted
March 7, 2023
Last Updated
October 17, 2023
Sponsor
Mclean Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT05776966
Brief Title
Women's Opioid Treatment Follow-up Study
Official Title
Increasing Women's Engagement in Medication Treatment for Opioid Use Disorder Through Digital Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to examine the feasibility of a gender-specific digital intervention for women with opioid use disorder. In this study, women with opioid use disorder will be randomized to receive treatment-as-usual plus a gender-specific digital intervention or treatment-as-usual only. Feasibility, satisfaction, and engagement with the intervention are the primary outcomes and will be measured post-intervention and at two-week, 6-week, and 12-week follow-up visits.
Detailed Description
This study has two aims: (1) to demonstrate the feasibility of delivering a gender-specific digital intervention (GSDI) to women with opioid use disorder; (2) to collect preliminary estimates on the effect of the GSDI on engagement in medication treatment for opioid use disorder (MOUD). The investigators will conduct a pilot randomized controlled trial to achieve these aims. Women (N=100) who have recently initiated MOUD (within 10 days) will be enrolled and randomized to receive either the GSDI+TAU (gender-specific digital intervention + treatment as usual) or TAU-only. Feasibility, satisfaction, and engagement with the GSDI are the primary outcomes and will be measured post-intervention and at two-week, 6-week, and 12-week follow-ups. MOUD engagement will be assessed at two time-points: (1) 6-weeks and (2) 12-weeks post-enrollment to collect preliminary estimates on the effect of the GSDI on MOUD engagement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gender-specific digital intervention plus treatment as usual (GSDI+TAU)
Arm Type
Experimental
Arm Description
GSDI + TAU includes the addition of a gender-specific digital intervention (GSDI) to treatment as usual. The GSDI has a web-based component and a mobile component. The web-based portion of the GSDI includes: (1) gender-specific psychoeducation on substance use disorders, (2) specific education on opioid use disorder, including information about medication treatment for opioid use disorder, and (3) information on relapse-prevention skills. Participants complete the web-based portion immediately after completing baseline assessments. The mobile component includes three parts: (1) weekly self-report surveys of opioid and other substance use and medication adherence, (2) weekly skills-practice exercises, and (3) daily motivational messages encouraging self-care. Participants engage with the mobile component after completing the web-based portion until the end of the study (12 weeks).
Arm Title
Treatment as usual (TAU)
Arm Type
Other
Arm Description
TAU for opioid use disorder consists of a mix of medication treatment and individual and group therapy services across various levels of care: inpatient, residential, and outpatient. Residential treatment is for adults who have completed detoxification and require additional treatment in a structured environment. Inpatient treatment includes short-term care and detoxification treatment and incorporates a combination of group, family, and individual therapy targeted at medical stabilization, reducing the severity of the patient's symptoms, and providing resources and ongoing support to prevent relapse. Outpatient treatment is focused on comprehensive evaluation and stabilization.
Intervention Type
Behavioral
Intervention Name(s)
Gender-specific digital intervention (GSDI)
Intervention Description
The GSDI is a digital intervention that incorporates factors that are more prevalent in women with opioid use disorder that may affect their treatment outcomes. The content for the intervention was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes.
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
Participants will receive treatment as usual for opioid use disorder which is a mix of medication treatment and individual and group therapy services across various levels of care.
Primary Outcome Measure Information:
Title
Client Satisfaction Questionnaire
Description
The Client Satisfaction Questionnaire (CSQ) assesses participant satisfaction of the digital intervention. The original CSQ has 8 items and we have added an additional 8 items to gather satisfaction with specific aspects of the digital intervention.
Time Frame
Immediately after the web-based portion of the intervention, Week 12
Title
System Usability Scale
Description
The System Usability Scale (SUS) is a 10-item questionnaire with five response options for respondents from Strongly agree to Strongly disagree. The SUS is used to measure usability of products and services, including hardware, software, mobile devices, websites, and applications.
Time Frame
12 weeks
Title
Engagement metrics
Description
Engagement data will be retrieved from MetricWire including number of logins, number of completed check-ins and skills practices, and time spent on each of these activities. Time spent on the web-based portion of the GSDI will be calculated from REDCap.
Time Frame
Week 1 - Week 12
Title
Qualitative Exit Interview
Description
Qualitative user experience exit interviews will be coded and analyzed using thematic analysis methodology to identify common themes.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Timeline Followback
Description
The Timeline Followback calendar method will be used to collect self-report data on medication for opioid use disorder adherence.
Time Frame
Week 2, Week 6, Week 12
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Due to the gender-specific focus of this study, only participants who do identify as women will be included.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18 years of age or older
current opioid use disorder diagnosis
have a smartphone
initiated medication treatment for opioid use disorder in the past 10 days,
able to provide informed consent
Exclusion Criteria:
an acute psychiatric or medical condition, or cognitive impairment, that would impair the ability to complete study procedures
admitted to their current treatment episode on an involuntary status
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dawn E. Sugarman, PhD
Phone
617-855-3650
Email
dsugarman@mclean.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Women's Opioid Treatment Follow-up Study
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