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

NCT05167695 | Active Not Recruiting DMC

• 1 other identifier: 2021-06-14409
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Circadian Dysregulation

Keywords

Habits; Circadian; Sleep; transdiagnostic; Intervention

Outcome Measures

Primary Outcomes (7)

• Self-Report Automaticity Habits Index integrated with the Utilization Scale

  16-item; 0-4 scale. Scores can range from 0 to 64 (Higher score means more automaticity in utilization).

  Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up

• Utilization Scale

  16-item; 0-4 scale. Scores can range from 0 to 64 (Higher score means more utilization).

  Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up

• Composite Sleep Health Score

  Composite Sleep Health Score which is defined as the sum of scores on 6 sleep health dimensions: Regularity (Midpoint fluctuation), Satisfaction (Sleep quality question on PROMIS-SD), Alertness (Daytime sleepiness question on PROMIS-SRI), Timing (Mean midpoint), Efficiency (Sleep efficiency) and Duration (Total Sleep Time). The Sleep Health Composite was constructed such that higher score indicates better sleep health.

  Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up

• Composite Scale of Morningness

  Sum of 13-item; Mix of 4-point and 5-point response scale. Scores can range from 13 (extreme evening) to 55 (extreme morning).

  Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up

• Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment (PROMIS-SRI)

  Sum of 8-items rated on a 5-point response scale. Scores can range from 8 to 40 (Higher score means more Sleep Related impairment)

  Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up

• Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (PROMIS-SD)

  Sum of 8-items rated on a 5-point response scale. Scores can range from 8 to 40 (Higher score means more Sleep Disturbance)

  Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up

• Adapted version of the Work and Social Adjustment Scale

  A measure of emotional, cognitive, physical, social and behavioral risk. The 5 items are each rated on a 0-8 scale. The 5 individual item scores will be summed into a total score (range: 0 to 40; Higher score means worse outcome).

  Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up

Secondary Outcomes (15)

• Pittsburgh Sleep Quality Index

  Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up

• Sleep Diary

  Baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up

• Actigraphy

  Baseline to 1-week post treatment

• Depression, Anxiety, and Stress Scale (DASS)

  Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up

• Brief Sensation Seeking Scale

  Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up

Other Outcomes (20)

• Adapted version of the Work and Social Adjustment Scale (individual items)

  Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up

• Self Report Habit Index: Secondary habit bundle to build

  At the end of the 2nd through last treatment session, which starts 2 to 3 weeks after the beginning of treatment. Also at 1-week post treatment, 6-month follow-up and 12-month follow-up

• Self Report Habit Index: Secondary habit bundle to dismantle

  At the end of the 2nd through last treatment session, which starts 2 to 3 weeks after the beginning of treatment. Also at 1-week post treatment, 6-month follow-up and 12-month follow-up

Study Arms (2)

Habit-based Sleep Health Intervention (HABITs)

EXPERIMENTAL

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.

Behavioral: Habit-based Sleep Health Intervention

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

EXPERIMENTAL

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.

Behavioral: Habit-based Sleep Health Intervention; Behavioral: Text messaging intervention

Interventions

Habit-based Sleep Health Intervention BEHAVIORAL

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

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

Text messaging intervention BEHAVIORAL

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

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

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• '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.
• Age between 18 and 30.
• English language fluency.
• Able and willing to give informed assent.
• If taking medication for sleep, the dose and frequency of use must have been stable for at least 4 weeks.

You may not qualify if:

• 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.
• 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.
• Night shifter worker where the shift is scheduled between the hours of midnight to 6am \> 2 nights per week.
• Pregnancy or breast-feeding.

Sponsors & Collaborators

• University of California, Berkeley: lead

Study Sites (1)

University of California

Berkeley, California, 94703, United States

Location

Related Publications (1)

• 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.

  PMID: 39563407 DERIVED

MeSH Terms

Conditions

Chronobiology Disorders; Habits

Condition Hierarchy (Ancestors)

Nervous System Diseases; Behavior

Study Officials

• Allison Harvey, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychology

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 22, 2021
• Study Start: May 4, 2022
• Primary Completion: December 20, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 5, 2025

Record last verified: 2025-11

Locations

US (1)