NCT05114577

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2022

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

11 months

First QC Date

October 29, 2021

Last Update Submit

December 12, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

  • Study participant retention

    Percent of participants who complete all 6 weeks of the study

    6 weeks

  • Study material completion

    Percent of participant who complete all of the study materials over the course of the study

    6 weeks

  • Study group attendance

    Percent of participants who attend all study group meetings

    6 weeks

  • Recruitment success

    Number of participants recruited into the study

    Baseline

Study Arms (2)

Recovery Sleepers program.

EXPERIMENTAL
Behavioral: Recovery Sleepers program.

Email recommendations

PLACEBO COMPARATOR
Behavioral: Email recommendations

Interventions

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.

Recovery Sleepers program.

Receive recommendations (via email) to help improve sleep

Email recommendations

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Behavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Natalie Dautovich, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2021

First Posted

November 10, 2021

Study Start

October 24, 2021

Primary Completion

October 3, 2022

Study Completion

October 3, 2022

Last Updated

December 14, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations