Clinical trial NCT05070143: Mini-treatment Experiments to Clarify How to Assist People to Habit Formation
Official title: Mini-treatment Experiments to Clarify How to Assist People to Formation Desired Habits and Disrupt Unwanted Habits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorder
Circadian Dysregulation
Habit, Good Sleep
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
First posted: 2021-10-07
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: The investigators motivation for considering a deeper application of the science of habit formation within clinical psychological science is that many researchers and clinicians consider the process of habit formation to be a "passive phenomenon," or "a 'natural' outcome of the behavior change process" rather than a process that can be specifically planned for and guided. In contrast, there are clear principles and strategies that the investigators can draw from, adapt and infuse into existing EBPTs to more intentionally incorporate the science of habit formation. Therefore, the investigators propose the study of habits is an important, fertile, creative and fascinating domain for future research.

To date, no prior research has been conducted on the disruption of habits. Hence, there is a great need for more naturalistic studies to delineate the contributors to knowledge about the multiple complex "real-life" habits that are tackled in EBPTs.

The theoretical grounding is drawn from health psychology, due to its conceptual proximity to clinical psychological science. In the health psychology literature, habit formation is understood to be a learned process whereby a behavior (the desired habit) becomes paired with a stable context cue and, via repetition, come to trigger an automatic impulse to engage in the habit. Repetition reinforces the behavior-context association. Reinforcement motivates and strengthens repetition. With ongoing repetition, the stable context cue becomes sufficient to activate the association. In other words, the context triggers the impulse to perform the behavior, with minimal cognitive effort or intention and the habit has become more automated and less reliant on one's goals.

Participants will be workers recruited from Amazon's Mechanical Turk (MTurk), an online labor marketplace that is also used as a recruitment platform for web-based studies, and which has a demonstrated reliability for producing high-quality research. The investigators aim to recruit 462 eligible participants.

A listing describing the proposed research will be posted to MTurk, where participants will be able to review the tasks involved in the study and compare the study to other opportunities on MTurk. Participants will complete the pre-screening assessment.

Eligible participants will be invited to complete the baseline session, which includes the pre-assessment, online learning module, and immediate post-assessment. Participants will be randomly allocated to one of the following experimental conditions immediately upon completing the online learning module. For each condition, participants will be instructed to identify a cue and reward/reinforcement for engaging in the new strategy.

One week after each condition is presented, the participant will be reminded of the instructions and will complete an assessment. Thereafter, at weekly intervals, participants will re-complete the assessments for another 4 weeks (i.e., each condition runs for 6 weeks). At 6-weeks and 3-months after the last assessment, the participants will re-complete the assessments.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
timeFrame: Change from baseline to 6-week follow-up and 3-month follow-up
measure: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment
timeFrame: Change from baseline to 6-week follow-up and 3-month follow-up
measure: New Habit Questionnaire
timeFrame: 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
measure: Old Habit Questionnaire
timeFrame: 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:
measure: Composite Sleep Health Score
timeFrame: Baseline
measure: Insomnia Severity Index - Interference Item
timeFrame: Change from screening to 6-week follow-up, 3-month follow-up
measure: Interference and Motivation Items
timeFrame: Change from baseline to 6-week follow-up, and 3-month follow-up
measure: Credibility Expectancy Scale
timeFrame: 1 week after baseline
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: University of California at Berkeley
state: California
Study officials:
affiliation: University of California, Berkeley
name: Allison Harvey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Berkeley
name: Laurel Sarfan, PhD
role: PRINCIPAL_INVESTIGATOR
References: