SleepNCT05114577
Recovery Sleepers: A Pilot Study of a Sleep Health Intervention for College Students in Recovery
A study testing Recovery Sleepers program. and Email recommendations in people with Sleep and Addiction, run by Virginia Commonwealth University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Recovery Sleepers program. and Email recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2021to 3 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
- Being tested
- Recovery Sleepers program., Email recommendations
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery Sleepers program.Behavioural
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 recommendationsBehavioural
Receive recommendations (via email) to help improve sleep
| Study group | Role | What they receive |
|---|---|---|
| Recovery Sleepers program. | Experimental | Not described Receives: Behavioral: Recovery Sleepers program. |
| Email recommendations | Placebo comparator | Not described Receives: Behavioral: Email recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Study participant retention
Percent of participants who complete all 6 weeks of the study
Measured: 6 weeks
Study material completion
Percent of participant who complete all of the study materials over the course of the study
Measured: 6 weeks
Study group attendance
Percent of participants who attend all study group meetings
Measured: 6 weeks
Recruitment success
Number of participants recruited into the study
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start24 Oct 2021
- Primary completion3 Oct 2022
- Study completion3 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Society for Health Psychology
- Responsible party
- Sponsor
- Investigators
- Natalie Dautovich, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114577
- Sponsor's protocol ID
- HM20022646
- Status last verified
- Dec 2022
- First submitted
- 29 Oct 2021
- Last updated
- 14 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Sleepers: A Pilot Study of a Sleep Health Intervention for College Students in Recovery
- ClinicalTrials.gov ID
- NCT05114577
- Acronym / sponsor ID
- HM20022646
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Society for Health Psychology
- Study start
- 24 Oct 2021 (actual)
- Primary completion
- 3 Oct 2022 (actual)
- Study completion
- 3 Oct 2022 (actual)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recovery Sleepers program. | Experimental | Behavioral: Recovery Sleepers program. |
| Email recommendations | Placebo comparator | Behavioral: Email recommendations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Recovery Sleepers program. |
| Email recommendationsReceive recommendations (via email) to help improve sleep | Behavioural | Email recommendations |
Primary outcome
Satisfaction with treatment
Time frame: 6 weeks
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.
Study participant retention
Time frame: 6 weeks
Percent of participants who complete all 6 weeks of the study
Study material completion
Time frame: 6 weeks
Percent of participant who complete all of the study materials over the course of the study
Study group attendance
Time frame: 6 weeks
Percent of participants who attend all study group meetings
Recruitment success
Time frame: Baseline
Number of participants recruited into the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalie Dautovich, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery Sleepers program. and Email recommendations in people with Sleep and Addiction, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with treatment (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.