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

NCT ID: NCT05167695

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-04
• Study Completion Date: 2026-07-01

Brief Summary

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.

Detailed Description

The study will test a sleep-health intervention that leverages the science on habit formation. Additionally, the investigators will evaluate whether adding a text messaging intervention improves habit formation. The participants will be 18-30 years old. This is a distinct developmental period in which priorities shift toward self-sufficiency and personal responsibility, which are supported by developing adaptive habits.

Main Aim. To evaluate if adding a text messaging intervention, derived from learning theory, to HABITs improves the utilization of sleep health behavior and improves sleep and circadian outcomes and functioning in the five health-relevant domain outcomes in the short (post-treatment) and longer term (6 and 12-months later), relative to HABITs without text messaging.

Main Hypothesis. Relative to HABITs, youth in HABITs+Texts will (a) establish stronger sleep health behavior habits, (b) report utilizing more sleep health behaviors and (c) exhibit improved sleep and circadian functioning and lower health-relevant risk. These effects will be observed at post-treatment as well as 6 and 12-months later.

Exploratory Aim: To evaluate if the Habit-based Sleep Health Intervention ('HABITs') is associated with an improvement in the utilization of sleep health behavior, an improvement in sleep and circadian outcomes and an improvement in functioning in the five health-relevant domain outcomes in the short (post-treatment) and longer term (6 and 12-months later), relative to baseline.

Exploratory Hypothesis. Combining across the HABITs and HABITs+Texts treatment arms, receiving either intervention will be associated with (a) improved sleep health behavior habits, (b) more utilization of sleep health behaviors, (c) improved sleep and circadian functioning and (d) lower health-relevant risk at post-treatment, 6- and 12-month follow-up, relative to baseline.

Additional exploratory analyses: To examine (a) if sleep health behavior that has become habitual mediates the effects of treatment on improvement in sleep, circadian and health outcomes and (b) if intervention effects are moderated by selected variables (e.g., age, sex, minority group, socioeconomic status (SES), season).

Conditions

Circadian Dysregulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Habit-based Sleep Health Intervention (HABITs)

Participants in this condition participate in the HABITs intervention which includes 3x50-minute weekly sessions followed by 6x30-minute weekly sessions.

Participants in this group will not receive the texts discussed below.

Group Type: EXPERIMENTAL

Habit-based Sleep Health Intervention

Intervention Type: BEHAVIORAL

A novel low-cost approach derived by leveraging the science of habit formation

Habit-based Sleep Health Intervention plus text messages (HABITs+texts)

Participants in this condition participate in the HABITs intervention which includes 3x50-minute weekly sessions followed by 6x30-minute weekly sessions.

Additionally, participants in this group will receive the text messaging intervention.

Group Type: EXPERIMENTAL

Text messaging intervention

Intervention Type: BEHAVIORAL

In addition to the Habit-based Sleep Health Intervention, the participants will also receive the text messaging intervention.

Habit-based Sleep Health Intervention

Intervention Type: BEHAVIORAL

A novel low-cost approach derived by leveraging the science of habit formation

Interventions

Text messaging intervention

In addition to the Habit-based Sleep Health Intervention, the participants will also receive the text messaging intervention.

Intervention Type: BEHAVIORAL

Habit-based Sleep Health Intervention

A novel low-cost approach derived by leveraging the science of habit formation

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion 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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Berkeley

OTHER

Sponsor Role: lead

Responsible Party

Allison Harvey

Professor of Clinical Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allison Harvey, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Berkeley

Locations

University of California

Berkeley, California, United States

Countries

United States

References

Diaz M, Ovalle Patino E, Oliver S, Tiab SS, Salazar N, Song J, Dong L, Sarfan LD, Susman ES, Agnew ER, Gardner B, Harvey AG. Integrating habit science and learning theory to promote maintenance of behavior change: does adding text messages to a habit-based sleep health intervention (HABITs) improve outcomes for eveningness chronotype young adults? Study protocol for a randomized controlled trial. Trials. 2024 Nov 20;25(1):782. doi: 10.1186/s13063-024-08599-4.

Reference Type: DERIVED

PMID: 39563407 (View on PubMed)

Other Identifiers

2021-06-14409

Identifier Type: -

Identifier Source: org_study_id