NCT05070143

Brief Summary

Habits impact nearly every domain of one's physical and mental health. Evidence-based psychological treatments (EBPTs) are interventions targeting psychological processes that cause and/or maintain mental illness and that have been developed and evaluated scientifically. An implicit goal of EBPTs is to disrupt unwanted habits and develop desired habits. Yet, there has been insufficient attention given to habit formation principles, theory and measures in the development and delivery of EBTPs. In preparing to conduct a 5-year R01 on this topic, the investigators are conducting this experiment to better understand habit formation. The purpose is to distill, study and clarify key concepts in habit formation before embarking on the 5-year R01. This is necessary as there is surprisingly little research to guide key decisions, particularly for the process of dismantling unwanted habits. Hence, the aim of this experiment is to compare strategies discussed in the scientific literature, which have been minimally studied, to dismantle unwanted habits. The hypothesis tested is that each of the active strategies will be superior to the no intervention group. The study is exploratory as to which of the active strategies will be most effective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
286

participants targeted

Target at P75+ 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

First Submitted

Initial submission to the registry

September 9, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 7, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

October 7, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

1.6 years

First QC Date

September 9, 2021

Last Update Submit

May 9, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Patient-Reported Outcomes Measurement Information System - Sleep Disturbance

    Assesses perceived functional impairments related to sleep problems using a self-report questionnaire. The minimum value is 8. The maximum value is 40. Higher scores mean more sleep disturbance (worse outcome).

    Change from baseline to 6-week follow-up and 3-month follow-up

  • Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment

    Assesses perceived functional impairments related to sleep problems in a self-report questionnaire. The minimum value is 16. The maximum value is 80. Higher scores mean more sleep-related impairment (worse outcome).

    Change from baseline to 6-week follow-up and 3-month follow-up

  • New Habit Questionnaire

    Assessment for new habit. Includes self-report questions on the description of new habit, usage and frequency of new habit, cues for new habit, and rewards for new habit.

    Change from baseline to Week 1, Week 2, Week 3, Week 4, Week 5, 6 weeks after Week 5, and 3 months after Week 5

  • Old Habit Questionnaire

    Assessment for old habit disruption. Includes self-report questions on the description of old habit, cues for old habit, and rewards for old habit.

    Change from baseline to Week 1, Week 2, Week 3, Week 4, Week 5, 6 weeks after Week 5, and 3 months after Week 5

Secondary Outcomes (4)

  • Composite Sleep Health Score

    Baseline

  • Insomnia Severity Index - Interference Item

    Change from screening to 6-week follow-up, 3-month follow-up

  • Interference and Motivation Items

    Change from baseline to 6-week follow-up, and 3-month follow-up

  • Credibility Expectancy Scale

    1 week after baseline

Study Arms (2)

Brief education

EXPERIMENTAL

Participants will be randomly allocated to the Brief Education condition or one of the five treatment conditions (see below). In this condition, participants only receive the learning module. This condition is included as a "minimal intervention" comparison condition that controls for the passage of time.

Behavioral: Brief Education

Treatment condition

EXPERIMENTAL

All participants will receive the Brief Education intervention described above. Then, participants will be randomly allocated to one of the following conditions for habit formation.

Behavioral: RISE-UP RoutineBehavioral: Awareness TrainingBehavioral: Vigilant MonitoringBehavioral: Implementation IntentionsBehavioral: Values-based ApproachBehavioral: Brief Education

Interventions

RISE-UP RoutineBEHAVIORAL

The participants in this condition will be instructed to substitute their current sleep habits with the RISE-UP routine that has been developed by our team (Kaplan, Talavera, \& Harvey, 2018). This involves instructing participants to devise an individually tailored routine that will help them get up each morning (e.g., open blinds, make the bed, head for the shower).

Treatment condition

The participants in this condition will be instructed in dismantling/disrupting the association between the cue and the habit via awareness training from habit reversal approaches (Azrin \& Nunn, 1973; Ladouceur, 1979). This condition involves instructing the participant to develop an awareness of their decisions to stay in bed and snooze.

Treatment condition

The participants in this condition will be instructed in vigilant monitoring which involves internal repetition of "get up!" and "don't do it" and watching carefully for slipups (Quinn, Pascoe, Wood, \& Neal, 2010).

Treatment condition

The participants in this condition will be instructed in counter habitual implementation intentions. This involves instructing the participant to engage in implementation intentions in which they imagine replacing snoozing with getting up out of bed (Adriaanse, Gollwitzer, De Ridder, De Wit, \& Kroese, 2011). The structure of this implementation intention is: "If I wake up in the morning and I want a sleep-in then I will get up and start my day."

Treatment condition

The participants in this condition will be instructed in a values-based approach (Anshel, Brinthaupt, \& Kang, 2010; Anshel \& Kang, 2007). This involves asking the participants to reflect on how getting up consistently at the same time each day does or does not align with their values. They are asked to compare the costs and long-term consequences of continuing to engage in the unwanted habit and clearly articulating the disconnect between the habit and their values.

Treatment condition
Brief EducationBEHAVIORAL

In this condition, participants only receive the learning module. This condition is included as a "minimal intervention" comparison condition that controls for the passage of time. First, education about the importance of regular wake times and sleep inertia that is a normal transitional stage between sleep and wake. The education will be delivered in this video format: https://www.youtube.com/watch?v=P6zcSFA7ymo. Second, after viewing the video, the key points will be summarized. Lastly, participants will be asked to summarize the four key takeaways for good sleep habits.

Brief educationTreatment condition

Eligibility Criteria

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

You may qualify if:

  • Over 18 years of age
  • Live in the United States
  • Have a 95% acceptance rate on MTurk
  • Have completed at least 1000 tasks on MTurk
  • Consent to participate in the research
  • Screened participants will complete a demographic form to enable us to compare the demographics of those included with those who are excluded.
  • We will ask questions to pre-select MT workers who:
  • Get less than 7 hours of sleep per night in the past week and
  • Have irregular wake-up times of 60 minutes or more across the week and
  • "snooze" in bed for more than 30 minutes on a typical morning in the past week
  • Report some distress or impairment related to sleep
  • Report motivation to improve their sleep or dismantle sleep-related habits
  • The items listed above will be ascertained with the Sleep Composite Timing Questions as well as the item assessing distress or impairment related to sleep from the Insomnia Severity Index and a rating of motivation (from the 'Interference and Motivation items'). On the latter two items, a score of 3 or 4 is needed to be accepted into the study.

You may not qualify if:

  • Not 18 years of age
  • Does not live in the United States

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California at Berkeley

Berkeley, California, 94720-1650, United States

Location

MeSH Terms

Conditions

Sleep Wake DisordersChronobiology DisordersSleep Hygiene

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersHealth BehaviorBehavior

Study Officials

  • Allison Harvey, PhD

    University of California, Berkeley

    PRINCIPAL INVESTIGATOR
  • Laurel Sarfan, PhD

    University of California, Berkeley

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2021

First Posted

October 7, 2021

Study Start

October 7, 2021

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations