Sleep DisorderNCT05070143
Mini-treatment Experiments to Clarify How to Assist People to Habit Formation
A study testing RISE-UP Routine, Awareness Training and Vigilant Monitoring in people with Sleep Disorder and Circadian Dysregulation, run by University of California, Berkeley at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disorder, Circadian Dysregulation, Habit, Good Sleep
- What is being tested?
- RISE-UP Routine, Awareness Training and Vigilant Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2021to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- Not 18 years of age
- Does not live in the United States
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California at Berkeley
Berkeley, California, 94720-1650
About this study
Official title: Mini-treatment Experiments to Clarify How to Assist People to Formation Desired Habits and Disrupt Unwanted Habits
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.
Read the 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.
- Conditions
- Sleep Disorder, Circadian Dysregulation, Habit, Good Sleep
- Being tested
- RISE-UP Routine, Awareness Training, Vigilant Monitoring, Implementation Intentions, Values-based Approach
- Medical subject headings
- Sleep Wake Disorders, Chronobiology Disorders, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RISE-UP RoutineBehavioural
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).
Awareness TrainingBehavioural
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.
Vigilant MonitoringBehavioural
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).
Implementation IntentionsBehavioural
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."
Values-based ApproachBehavioural
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.
Brief EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: RISE-UP Routine; Behavioral: Awareness Training; Behavioral: Vigilant Monitoring; Behavioral: Implementation Intentions; Behavioral: Values-based Approach; Behavioral: Brief Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
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).
Measured: Baseline
Insomnia Severity Index - Interference Item
Assessing the extent to which sleep problems interfere with daily functioning.
Measured: Change from screening to 6-week follow-up, 3-month follow-up
Interference and Motivation Items
Assessing the extent to which sleep problems interfere with daily functioning and the participant's motivation.
Measured: Change from baseline to 6-week follow-up, and 3-month follow-up
Credibility Expectancy Scale
One credibility item drawn from the Credibility Expectancy Scale. Measures the credibility and expectation of improvement from the research-supported strategy. Scores can range from 1-9 with higher scores indicating higher satisfaction in the research-supported strategy.
Measured: 1 week after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start7 Oct 2021
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Harvey, University of California, Berkeley
- Investigators
- Allison Harvey, PhD, Principal investigator, University of California, BerkeleyLaurel Sarfan, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070143
- Sponsor's protocol ID
- MTurk Study Habit Formation
- Status last verified
- May 2023
- First submitted
- 9 Sep 2021
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini-treatment Experiments to Clarify How to Assist People to Formation Desired Habits and Disrupt Unwanted Habits
- ClinicalTrials.gov ID
- NCT05070143
- Acronym / sponsor ID
- MTurk Study Habit Formation
- Conditions
- Sleep Disorder, Circadian Dysregulation, Habit, Good Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 7 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief education | Experimental | Behavioral: Brief EducationParticipants 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. |
| Treatment condition | Experimental | Behavioral: RISE-UP Routine, Behavioral: Awareness Training, Behavioral: Vigilant Monitoring, Behavioral: Implementation Intentions, Behavioral: Values-based Approach, Behavioral: Brief EducationAll participants will receive the Brief Education intervention described above. Then, participants will be randomly allocated to one of the following conditions for habit formation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (2 listed)
- Not 18 years of age
- Does not live in the United States
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RISE-UP RoutineThe 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). | Behavioural | Treatment condition |
| Awareness TrainingThe 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. | Behavioural | Treatment condition |
| Vigilant MonitoringThe 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). | Behavioural | Treatment condition |
| Implementation IntentionsThe 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." | Behavioural | Treatment condition |
| Values-based ApproachThe 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. | Behavioural | Treatment condition |
| Brief EducationIn 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. | Behavioural | Brief education, Treatment condition |
Primary outcome
Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
Time frame: Change from baseline to 6-week follow-up and 3-month follow-up
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).
Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment
Time frame: Change from baseline to 6-week follow-up and 3-month follow-up
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).
New Habit Questionnaire
Time frame: 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
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.
Old Habit Questionnaire
Time frame: 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
Assessment for old habit disruption. Includes self-report questions on the description of old habit, cues for old habit, and rewards for old habit.
4 secondary outcomes
Composite Sleep Health Score
Time frame: Baseline
Insomnia Severity Index - Interference Item
Time frame: Change from screening to 6-week follow-up, 3-month follow-up
Interference and Motivation Items
Time frame: Change from baseline to 6-week follow-up, and 3-month follow-up
Credibility Expectancy Scale
Time frame: 1 week after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Harvey, PhD principal investigator
University of California, Berkeley
Laurel Sarfan, PhD principal investigator
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RISE-UP Routine, Awareness Training and Vigilant Monitoring in people with Sleep Disorder and Circadian Dysregulation, run by University of California, Berkeley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (time frame: Change from baseline to 6-week follow-up and 3-month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.