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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05114577
Other study ID # HM20022646
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 24, 2021
Est. completion date October 3, 2022

Study information

Verified date December 2022
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research study is to examine how to improve sleep in college students in recovery from substance use disorder(s). This study is a pilot test of an experimental program called Recovery Sleepers (RS) to explore its feasibility and how well it works to improve sleep, wellbeing, and cravings.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date October 3, 2022
Est. primary completion date October 3, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - More than 18 years of age - Enrolled (full- or part-time) at a college or university - Have struggled with substance addiction in the past - More than 3 months of self-reported continuous abstinence from alcohol and all illegal drugs - Have an Internet-enabled device with audio capabilities. Exclusion Criteria: - Younger than 18 years of age - Not enrolled at VCU - Have not struggled with substance addiction in the past - Have not had at least 3 months of self-reported continuous abstinence from alcohol and all - illegal drugs - In active treatment for a sleep disorder (seen a health provider specifically regarding sleep within the last 6 months) - Unable to communicate in English both orally and in writing - Do not have an Internet-enabled device with audio capabilities.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Recovery Sleepers program.
Attend two, 90-minute remote discussion groups (~10 other participants and 2 study team members) via Zoom. During these groups, participants will receive educational materials about how to improve sleep. They will also discuss sleep and sleep-related behaviors, including how active substance use and recovery may have changed sleep, with a small group of other participants.
Email recommendations
Receive recommendations (via email) to help improve sleep

Locations

Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (2)

Lead Sponsor Collaborator
Virginia Commonwealth University Society for Health Psychology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Satisfaction with treatment Participants will rate their experiences in the study using a scale from 1 (Strongly disagree) to 5 (Strongly agree). Treatment and placebo groups will answer a different number of questions. Scores will be averaged to yield a single score between 1 and 5. 6 weeks
Primary Study participant retention Percent of participants who complete all 6 weeks of the study 6 weeks
Primary Study material completion Percent of participant who complete all of the study materials over the course of the study 6 weeks
Primary Study group attendance Percent of participants who attend all study group meetings 6 weeks
Primary Recruitment success Number of participants recruited into the study Baseline
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