Research and Engagement on Substance Use: Harnessing Awareness and Personalized Education (RESHAPE) to Improve Well-being and Self-efficacy

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 21 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: United States residents

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Conditions

Substance Use Disorder (SUD)

Keywords

Substance abuse

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Phase 1A: Willingness to participate in a future substance use disorder program

   Number and percentage of interview and survey respondents reporting willingness to participate in a future substance use disorder program

   Measured: Baseline

2. Phase 1A: Perceived usefulness and expected use of a future program's potential features and content

   Number and percentage of interview and survey respondents reporting that the future program's potential features are useful

   Measured: Baseline

3. Phase 1B: To quantify and describe real-world health related social needs and/or substance use and/or demographics survey(s) previously collected on the Evidation platform

   Number and percentage of interview and survey respondents who completed at least one health related social needs and/or substance use and/or demographics survey on the Evidation platform in the past year

   Measured: From approximately 1 year prior to enrollment until study enrollment

4. Phase 1B: Perceived expected use of potential features and content to be included in a program to improve well-being and self-efficacy for health promoting activities

   Number and percentage of interview and survey respondents reporting that they expect to use each of the future program's potential features and content

   Measured: Baseline

5. Phase 1B: To quantify and describe real-world data from a connected wearable device previously collected on the Evidation platform

   Average number of days with valid steps, sleep, and heart rate data from a connected wearable device in the past year

   Measured: From approximately 1 year prior to enrollment until study enrollment

6. Phase 1B: To quantify and describe real-world data from responses to daily mood, stress, and sleep diaries previously collected on the Evidation platform

   Average number of days with responses to daily mood, stress, and sleep diaries in the past year

   Measured: From approximately 1 year prior to enrollment until study enrollment

7. Phase 2: Monthly engagement with the RESHAPE Experience

   Participant engagement will be assessed using the following monthly measures: (1) average number of in-app activities completed per participant, (2) average number of in-app activities dismissed per participant, and (3) average number of in-app impressions per participant.

   Measured: Through 3 months, 6 months, and 12 months after Phase 2 enrollment

8. Phase 2: Weekly completion of substance-use and well-being check-ins

   For each study week, the number and percentage of Phase 2 participants completing at least one substance-use check-in and the number and percentage completing at least one well-being check-in will be calculated. The average weekly percentages will be summarized across the Phase 2 study period.

   Measured: 3 months, 6 months, and 12 months after Phase 2 enrollment

9. Phase 2: Change from baseline in self-reported well-being

   Change in self-reported well-being from baseline to 3 month, 6 months, and 12 months post enrollment.

   Measured: Through 3 months, 6 months, and 12 months after Phase 2 enrollment

10. Phase 2: Satisfaction with the RESHAPE Experience

    Participant satisfaction with the RESHAPE Experience as measured by survey.

    Measured: Through 3 months, 6 months, and 12 months after Phase 2 enrollment

11. Phase 2: Willingness to participate in future research

    Number and percentage of Phase 2 participants reporting willingness to participate in future research

    Measured: Through 3 months, 6 months, and 12 months after Phase 2 enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted1 May 2025
2. Study start22 Apr 2025
3. Primary completionDec 2027 (estimated)
4. Study completionApr 2028 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (14)Papers the sponsor has linked to this study.
• Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
• 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.