Trial Outcomes & Findings for Feasibility and Acceptability of a Stigma Text Message Intervention for People Who Use Drugs (NCT NCT06281548)

Last Updated: 2024-07-10

Results Overview

This is a 20-item Likert-type scale that assesses participants' capacity to resist stigma in five domains (self-other differentiation, personal identity, personal cognitions, peer stigma resistance, public stigma resistance). All items are scored such that higher scores reflect greater stigma resistance. Total scale score ranges from 20-100.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

Baseline, 4-week follow-up visit

Results posted on

2024-07-10

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Arm Participants in the intervention arm will receive 56 text messages over 4-weeks. RESTART: Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages address the four components of the personal level of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use. Content is informed by evidence-based psychotherapeutic approaches (e.g., Acceptance and Commitment Therapy) and health communication theory (e.g., Elaboration Likelihood Model). Messages include psychoeducation about substance use and stigma, coping advice, and suggestions for how to set personal goals, identify values, and build self-esteem.
Overall Study STARTED	30
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Arm Participants in the intervention arm will receive 56 text messages over 4-weeks. RESTART: Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages address the four components of the personal level of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use. Content is informed by evidence-based psychotherapeutic approaches (e.g., Acceptance and Commitment Therapy) and health communication theory (e.g., Elaboration Likelihood Model). Messages include psychoeducation about substance use and stigma, coping advice, and suggestions for how to set personal goals, identify values, and build self-esteem.
Overall Study Lost to Follow-up	3

Baseline Characteristics

Feasibility and Acceptability of a Stigma Text Message Intervention for People Who Use Drugs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Arm n=30 Participants Participants in the intervention arm will receive 56 text messages over 4-weeks. RESTART: Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages address the four components of the personal level of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use. Content is informed by evidence-based psychotherapeutic approaches (e.g., Acceptance and Commitment Therapy) and health communication theory (e.g., Elaboration Likelihood Model). Messages include psychoeducation about substance use and stigma, coping advice, and suggestions for how to set personal goals, identify values, and build self-esteem.
Age, Continuous	37.3 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex/Gender, Customized Gender · Men	13 Participants n=5 Participants
Sex/Gender, Customized Gender · Women	17 Participants n=5 Participants
Sex/Gender, Customized Gender · Non-binary / third gender	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants
Educational Attainment Less than high school diploma	4 Participants n=5 Participants
Educational Attainment High school diploma or GED	15 Participants n=5 Participants
Educational Attainment Some college but no degree	10 Participants n=5 Participants
Educational Attainment Associates degree, trade or technical school	0 Participants n=5 Participants
Educational Attainment Bachelors degree, other 4 year college degree, or higher	1 Participants n=5 Participants
Employment Status Working - full-time	3 Participants n=5 Participants
Employment Status Working - part-time	3 Participants n=5 Participants
Employment Status Unemployed	22 Participants n=5 Participants
Employment Status Not in the labor force	2 Participants n=5 Participants
Substance Abuse Self-Stigma Scale	124.7 units on a scale STANDARD_DEVIATION 21.2 • n=5 Participants
Stigma Resistance Scale	74.7 units on a scale STANDARD_DEVIATION 12.8 • n=5 Participants
Adult Dispositional Hope Scale	43.8 units on a scale STANDARD_DEVIATION 10.1 • n=5 Participants
Rosenberg Self-Esteem Scale	23.5 units on a scale STANDARD_DEVIATION 4.5 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 4-week follow-up visit

Population: Includes participants not lost-to-follow-up with complete data.

Outcome measures

Outcome measures
Measure	Intervention Arm n=25 Participants Participants in the intervention arm will receive 56 text messages over 4-weeks. RESTART: Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages address the four components of the personal level of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use. Content is informed by evidence-based psychotherapeutic approaches (e.g., Acceptance and Commitment Therapy) and health communication theory (e.g., Elaboration Likelihood Model). Messages include psychoeducation about substance use and stigma, coping advice, and suggestions for how to set personal goals, identify values, and build self-esteem.
Change in Stigma Resistance Scale (SRS) Score	6.28 score on a scale Interval 1.04 to 11.52

PRIMARY outcome

Timeframe: Baseline, 4-week follow-up visit

Population: Includes participants not lost-to-follow-up with complete data.

This is a 40-item Likert-type scale that assesses degree to which participants internalize judgment for their substance use and fear experiencing stigma from others. The scale includes four subscales: self-devaluation (8 items), fear of enacted stigma (9 items), stigma avoidance (13 items), and values disengagement (10 items). Total scale score ranges from 40-200, where higher scores reflect higher levels of self-stigma. The self-devaluation, fear of enacted stigma, and stigma avoidance subscales are scored normally, while the values disengagement subscale is reverse scored.

Outcome measures

Outcome measures
Measure	Intervention Arm n=19 Participants Participants in the intervention arm will receive 56 text messages over 4-weeks. RESTART: Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages address the four components of the personal level of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use. Content is informed by evidence-based psychotherapeutic approaches (e.g., Acceptance and Commitment Therapy) and health communication theory (e.g., Elaboration Likelihood Model). Messages include psychoeducation about substance use and stigma, coping advice, and suggestions for how to set personal goals, identify values, and build self-esteem.
Change in Substance Abuse Self-Stigma Scale (SASSS) Score	-14.47 score on a scale Interval -26.95 to -2.0

PRIMARY outcome

Timeframe: From first recruitment visit to last recruitment visit (up to 4 weeks)

Population: Includes all screened prospective participants

Percentage of potential participants screened for study eligibility who are eligible for participation.

Outcome measures

Outcome measures
Measure	Intervention Arm n=48 Participants Participants in the intervention arm will receive 56 text messages over 4-weeks. RESTART: Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages address the four components of the personal level of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use. Content is informed by evidence-based psychotherapeutic approaches (e.g., Acceptance and Commitment Therapy) and health communication theory (e.g., Elaboration Likelihood Model). Messages include psychoeducation about substance use and stigma, coping advice, and suggestions for how to set personal goals, identify values, and build self-esteem.
Percentage of Prospective Participants Eligible for Participation (Feasibility - Recruitment) Eligible	93.8 Percentage of participants
Percentage of Prospective Participants Eligible for Participation (Feasibility - Recruitment) Ineligible	6.3 Percentage of participants

PRIMARY outcome

Timeframe: From first recruitment visit to last enrollment visit (up to 4 weeks)

Population: Includes eligible prospective participants

Percentage of potential participants screened for study eligibility who enroll in the study.

Outcome measures

Outcome measures
Measure	Intervention Arm n=45 Participants Participants in the intervention arm will receive 56 text messages over 4-weeks. RESTART: Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages address the four components of the personal level of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use. Content is informed by evidence-based psychotherapeutic approaches (e.g., Acceptance and Commitment Therapy) and health communication theory (e.g., Elaboration Likelihood Model). Messages include psychoeducation about substance use and stigma, coping advice, and suggestions for how to set personal goals, identify values, and build self-esteem.
Percentage of Prospective Participants Recruited Into Study (Feasibility - Enrollment) Enrolled	66.7 Percentage of participants
Percentage of Prospective Participants Recruited Into Study (Feasibility - Enrollment) Not enrolled	33.3 Percentage of participants

PRIMARY outcome

Timeframe: From first recruitment visit to last enrollment visit (up to 4 weeks)

Time in days to enroll the full sample size (n=30), starting from the first recruitment visit

Outcome measures

Outcome measures
Measure	Intervention Arm n=30 Participants Participants in the intervention arm will receive 56 text messages over 4-weeks. RESTART: Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages address the four components of the personal level of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use. Content is informed by evidence-based psychotherapeutic approaches (e.g., Acceptance and Commitment Therapy) and health communication theory (e.g., Elaboration Likelihood Model). Messages include psychoeducation about substance use and stigma, coping advice, and suggestions for how to set personal goals, identify values, and build self-esteem.
Time to Sample Saturation (Feasibility - Recruitment)	14 days

PRIMARY outcome

Timeframe: From first enrollment visit to study completion date (up to 8 weeks)

Percentage of participants enrolled in the study who are retained through study completion (i.e., complete 4-week follow-up survey).