Circadian DysregulationNCT05167695
Maintaining Behavior Change: An Evaluation of a Habit-based Sleep Health Intervention
A study testing Habit-based Sleep Health Intervention and Text messaging intervention in people with Circadian Dysregulation, run by University of California, Berkeley at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Circadian Dysregulation
- What is being tested?
- Habit-based Sleep Health Intervention and Text messaging intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2022to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California
Berkeley, California, 94703
About this study
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.
Read the 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
- Being tested
- Habit-based Sleep Health Intervention, Text messaging intervention
- Keywords
- Habits, Circadian, Sleep, transdiagnostic, Intervention
- Medical subject headings
- Chronobiology Disorders, Habits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Habit-based Sleep Health InterventionBehavioural
A novel low-cost approach derived by leveraging the science of habit formation
Text messaging interventionBehavioural
In addition to the Habit-based Sleep Health Intervention, the participants will also receive the text messaging intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Habit-based Sleep Health Intervention; Behavioral: Text messaging intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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).
Measured: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Secondary outcomes (15)
Pittsburgh Sleep Quality Index
19-item. First four items are integer responses. The rest of the items are on a 0-3 scale. Creates 7 composite scores, with the sum of the composite scores ranging from 0 to 21. (Higher score means increased severity of difficulty in all sleep area components).
Measured: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Sleep Diary
(Not a scale); Night-to-night variability in the mid-point of sleep
Measured: Baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Actigraphy
(Not a scale); Night-to-night variability in the mid-point of sleep
Measured: Baseline to 1-week post treatment
Depression, Anxiety, and Stress Scale (DASS)
Three subscales-depression, anxiety, stress-of 7 items each, ranging from 0-3 per item. Subscale scores range from 0-21. Final scores are multiplied by two. Higher scores mean worse outcomes. Total score will also be calculated.
Measured: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Brief Sensation Seeking Scale
8-item; 5-point response scale; Scores can range from 8 to 40 (Higher score means higher sensation seeking).
Measured: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Physical Health Questionnaire
Sum of 15-item, 0-2 response scale. Scores can range from 0 to 30 (Higher score means worse physical symptoms)
Measured: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
PROMIS-Cognitive Function
6-item; 1-5 response scale. Scores can range from 6-30 (Higher score means better cognitive functioning)
Measured: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
PROMIS-Ability to participate
4-item; 1-5 response scale. Scores can range from 4-20 (Higher score means better social functioning)
Measured: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Ecological Momentary Assessment Composite Risk Score of Functioning - Emotion
(Not a scale) Measured via Ecological Momentary Assessment. a 16-item version of the Positive and Negative Affect Schedule will be administered. The Positivity Ratio will also be calculated.
Measured: Change from baseline to 1-week post treatment
Ecological Momentary Assessment Composite Risk Score of Functioning - Cognitive Domain
(Not a scale) Measured via Ecological Momentary Assessment. Concentration, distractedness and focus are rated on a 5 point scale.
Measured: Change from baseline to 1-week post treatment
Ecological Momentary Assessment (EMA) Composite Risk Score of Functioning - Behavioral Domain
(Not a scale) Measured via Ecological Momentary Assessment. The investigators assess eating, caffeine, alcohol, nicotine, marijuana, opioids and prescription and over the counter (OTC) stimulants and sleep aids. Participants will also be asked to list the use of additional psychoactive drugs (e.g. cocaine). The investigators tabulate the average weekly frequency and intake of each substance.
Measured: Change from baseline to 1-week post treatment
Ecological Momentary Assessment Composite Risk Score of Functioning - Social Domain
(Not a scale) Measured via Ecological Momentary Assessment. will assess if the participant is with anyone at the time of the call. Positivity Ratio (see EMA for Emotional Health) will be calculated when the participant is alone, with a family member or with a friend.
Measured: Change from baseline to 1-week post treatment
Ecological Momentary Assessment Composite Risk Score of Functioning - Physical Domain
(Not a scale) Measured via Ecological Momentary Assessment. Physical activity and sedentary behaviors will be assessed.
Measured: Change from baseline to 1-week post treatment
Self Report Habit Index: Primary habit bundle to build
6 items rated on 1-5 scale. Scores can range from 1 to 30
Measured: 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: Primary habit bundle to dismantle
6 items rated on 1-5 scale. Scores can range from 0 to 30
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start4 May 2022
- Primary completion20 Dec 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Circadian DysregulationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
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, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167695
- Sponsor's protocol ID
- 2021-06-14409
- Status last verified
- Nov 2025
- First submitted
- 29 Nov 2021
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39563407
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintaining Behavior Change: An Evaluation of a Habit-based Sleep Health Intervention
- ClinicalTrials.gov ID
- NCT05167695
- Acronym / sponsor ID
- 2021-06-14409
- Conditions
- Circadian Dysregulation
- Keywords
- Habits, Circadian, Sleep, transdiagnostic, Intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Study start
- 4 May 2022 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 22 Dec 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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Habit-based Sleep Health Intervention (HABITs) | Experimental | Behavioral: Habit-based Sleep Health InterventionParticipants 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. |
| Habit-based Sleep Health Intervention plus text messages (HABITs+texts) | Experimental | Behavioral: Habit-based Sleep Health Intervention, Behavioral: Text messaging interventionParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Habit-based Sleep Health InterventionA novel low-cost approach derived by leveraging the science of habit formation | Behavioural | Habit-based Sleep Health Intervention (HABITs), Habit-based Sleep Health Intervention plus text messages (HABITs+texts) |
| Text messaging interventionIn addition to the Habit-based Sleep Health Intervention, the participants will also receive the text messaging intervention. | Behavioural | Habit-based Sleep Health Intervention plus text messages (HABITs+texts) |
Primary outcome
Self-Report Automaticity Habits Index integrated with the Utilization Scale
Time frame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
16-item; 0-4 scale. Scores can range from 0 to 64 (Higher score means more automaticity in utilization).
Utilization Scale
Time frame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
16-item; 0-4 scale. Scores can range from 0 to 64 (Higher score means more utilization).
Composite Sleep Health Score
Time frame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
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.
Composite Scale of Morningness
Time frame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Sum of 13-item; Mix of 4-point and 5-point response scale. Scores can range from 13 (extreme evening) to 55 (extreme morning).
Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment (PROMIS-SRI)
Time frame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
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)
Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (PROMIS-SD)
Time frame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Sum of 8-items rated on a 5-point response scale. Scores can range from 8 to 40 (Higher score means more Sleep Disturbance)
Adapted version of the Work and Social Adjustment Scale
Time frame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
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).
15 secondary outcomes
Pittsburgh Sleep Quality Index
Time frame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Sleep Diary
Time frame: Baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Actigraphy
Time frame: Baseline to 1-week post treatment
Depression, Anxiety, and Stress Scale (DASS)
Time frame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Brief Sensation Seeking Scale
Time frame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Physical Health Questionnaire
Time frame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
PROMIS-Cognitive Function
Time frame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
PROMIS-Ability to participate
Time frame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Ecological Momentary Assessment Composite Risk Score of Functioning - Emotion
Time frame: Change from baseline to 1-week post treatment
Ecological Momentary Assessment Composite Risk Score of Functioning - Cognitive Domain
Time frame: Change from baseline to 1-week post treatment
Ecological Momentary Assessment (EMA) Composite Risk Score of Functioning - Behavioral Domain
Time frame: Change from baseline to 1-week post treatment
Ecological Momentary Assessment Composite Risk Score of Functioning - Social Domain
Time frame: Change from baseline to 1-week post treatment
Ecological Momentary Assessment Composite Risk Score of Functioning - Physical Domain
Time frame: Change from baseline to 1-week post treatment
Self Report Habit Index: Primary habit bundle to build
Time frame: 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: Primary habit bundle to dismantle
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Derived from this study: PubMed 39563407Diaz 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.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Habit-based Sleep Health Intervention and Text messaging intervention in people with 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 6 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Self-Report Automaticity Habits Index integrated with the Utilization Scale (time frame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05167695, which also lists 1 linked publication.
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 5 Nov 2025.