ACTIVE_NOT_RECRUITING

Maintaining Behavior Change: An Evaluation of a Habit-based Sleep Health Intervention

Conditions

Circadian Dysregulation Habits Circadian Sleep transdiagnostic Intervention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study will test a sleep-health intervention that leverages the science on habit formation. It will evaluate if adding a text messaging intervention improves habit formation. The participants will be 18-30 years old.

Official Title

Maintaining Behavior Change: An Evaluation of a Habit-based Sleep Health Intervention

Quick Facts

Study Start:2022-05-04

Study Completion:2026-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05167695

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 30 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Scoring less than or equal to 26 on the Composite Scale of Morningness OR Mid-point of sleep later than 4:30 AM for 18-24 yo and 3:50 AM for 25-30 yo on work-free/weekend days over the past month OR Night-to-night variation in sleep and wake times across one month of 2 hours or more. 2. 'At risk' in one of the five health domains: the emotional domain, the cognitive domain, the behavioral domain, the physical domain and the social domain. "Risk" is defined as scoring 4 or higher on one item from an adapted version of the Work and Social Adjustment Scale. 3. Age between 18 and 30. 4. English language fluency. 5. Able and willing to give informed assent. 6. If taking medication for sleep, the dose and frequency of use must have been stable for at least 4 weeks.	1. Presence of substance abuse/dependence, mental illness, physical illness, suicidality or developmental disorder only if it makes participation in the study unfeasible or if there is a significant risk of harm and/or decompensation if treatment of that comorbid condition is delayed due to participating in this study. 2. Evidence of sleep apnea, restless legs or periodic limb movements during sleep. Youth presenting with provisional diagnoses of any of these disorders will be referred for a non-study polysomnography evaluation and will be enrolled only if the diagnosis is disconfirmed or if the disorder is treated. 3. Night shifter worker where the shift is scheduled between the hours of midnight to 6am \> 2 nights per week. 4. Pregnancy or breast-feeding.

Inclusion Criteria

Exclusion Criteria

1. Scoring less than or equal to 26 on the Composite Scale of Morningness OR Mid-point of sleep later than 4:30 AM for 18-24 yo and 3:50 AM for 25-30 yo on work-free/weekend days over the past month OR Night-to-night variation in sleep and wake times across one month of 2 hours or more.
2. 'At risk' in one of the five health domains: the emotional domain, the cognitive domain, the behavioral domain, the physical domain and the social domain. "Risk" is defined as scoring 4 or higher on one item from an adapted version of the Work and Social Adjustment Scale.
3. Age between 18 and 30.
4. English language fluency.
5. Able and willing to give informed assent.
6. If taking medication for sleep, the dose and frequency of use must have been stable for at least 4 weeks.

1. Presence of substance abuse/dependence, mental illness, physical illness, suicidality or developmental disorder only if it makes participation in the study unfeasible or if there is a significant risk of harm and/or decompensation if treatment of that comorbid condition is delayed due to participating in this study.
2. Evidence of sleep apnea, restless legs or periodic limb movements during sleep. Youth presenting with provisional diagnoses of any of these disorders will be referred for a non-study polysomnography evaluation and will be enrolled only if the diagnosis is disconfirmed or if the disorder is treated.
3. Night shifter worker where the shift is scheduled between the hours of midnight to 6am \> 2 nights per week.
4. Pregnancy or breast-feeding.

Contacts and Locations

Principal Investigator

Allison Harvey, PhD

PRINCIPAL_INVESTIGATOR

University of California, Berkeley

Study Locations (Sites)

University of California

Berkeley, California, 94703

United States

Collaborators and Investigators

Sponsor: University of California, Berkeley

Allison Harvey, PhD, PRINCIPAL_INVESTIGATOR, University of California, Berkeley

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-04

Study Completion Date2026-07-01

Study Record Updates

Study Start Date2022-05-04

Study Completion Date2026-07-01

Terms related to this study

Keywords Provided by Researchers

Habits
Circadian
Sleep
transdiagnostic
Intervention

Additional Relevant MeSH Terms

Circadian Dysregulation