Sleep Wake DisordersNCT02961400
Improving Memory for Sleep Treatment Content With Text Messages
A study testing PUSH text messages, PULL text messages and TranS-C in people with Sleep Wake Disorders, run by University of California, Berkeley at 1 site in United States.
Trial summary
A drop off in improvement over the months and years after treatment is common. One contributor may be poor memory for the contents of treatment. This study seeks to determine whether text messages containing reminders of the content of sessions will improve treatment outcomes. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Sleep Wake Disorders
- What is being tested?
- PUSH text messages, PULL text messages and TranS-C
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2018
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Scoring within the lowest quartile of the Children's Morningness-Eveningness Preferences Scale (CMEP; 27 or lower) and a 7-day sleep diary showing a sleep onset time of of 10:40 pm or later for 10-13 year olds, 11 pm or later for 14-16 year olds, and 11:20 pm or later for 17-18 year olds at least 3 nights per week. Must have had the current pattern of late bedtimes for the last 3 months.
- 'At risk' in one of the five health domains: emotional, behavioral, social, physical, and cognitive. Emotional risk will be operationalized as a score of 4 or above on any of the following items on the Child Depression Rating Scale: Difficulty Having Fun, Social Withdrawal, Irritability, Depressed Feelings, Excessive Weeping, or a T-score of 61 or above on the Multidimensional Anxiety Scale for Children (MASC), based on age group (10-11 years, 12-15 year, 16-19 years) using the MASC-10 Profile. Behavioral risk will be operationalized as a Sensation Seeking Scale score greater than 3.93 for males ages 10-13, greater than 3.19 for females 10-13, greater than 4.07 for males 14-18, or greater than 3.19 for females 14-18; taking ADHD medication or Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADs) diagnosis of ADHD; current alcohol or substance abuse; or past alcohol or substance dependence. Social and cognitive risk will be defined as "worse" than others the teen's age in one or more social behavior from Child Behavior Checklist (CBCL) Section VI or failing one or more academic class from CBCL Section VII, respectively. Physical risk will be operationalized as a Physical Health Questionnaire-15 score of 4 or above, six or more days of school absences, or a BMI above the 85th percentile for the participant's sex and age.
- Age between 10 and 18 and living with a parent or guardian and and attending a class/job by 9am at least 3 days per week;
- English language fluency;
- Able and willing to give informed assent.
Who cannot join
- An active, progressive physical illness (e.g., cancer, respiratory disorder) or neurological degenerative disease directly related to the onset and course of the sleep disturbance;
- Evidence from clinical diagnosis or report by youth or parent of sleep apnea, restless legs or periodic limb movements during sleep. Youth presenting with provisional diagnoses of any of these disorders (e.g., sleep apnea) will be referred for a non-study polysomnography (PSG) evaluation at the parent's discretion and will be enrolled only if the diagnosis is disconfirmed;
- Mental retardation, autism spectrum disorder, or other significantly impairing pervasive developmental disorder. Based on previous recruitment experiences in a youth depression study, it is expected that this exclusion will be invoked very infrequently (once every few years);
- Bipolar disorder or schizophrenia or another current Axis I disorder if there is a significant risk of harm and/or decompensation if treatment of that comorbid condition is delayed as a function of participating in any stage of this study. Otherwise, all other comorbid psychiatric conditions will be allowed to (i) to maximize representativeness and (ii) because a byproduct may be that the treatment constitutes a helpful 'transdiagnostic' treatment for youth across psychiatric disorders.
- A medication-free group may be difficult to recruit and would likely be unrepresentative. Hence, participants will not be excluded on the basis of stable use of medications (> 4 weeks). The exception was use of hypnotics and other medications known to alter sleep (e.g., melatonin).
- History of substance dependence in the past six months;
- Current suicide risk sufficient to preclude treatment on an outpatient basis.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Berkeley
Berkeley, California, 94720
About this study
A drop off in improvement over the months and years after treatment is common. One contributor may be poor memory for the contents of treatment. This study seeks to determine whether text messages containing reminders of the content of sessions will improve treatment outcomes.
Read the detailed description
The growth in the use of technology provides an opportunity to send reminders to participants via text messages. The early studies on text messaging interventions indicate this approach is enjoyable for participants and has positive effects across a range of domains and treatment types. Hence, this study will test whether text messages containing reminders of the content of sessions will improve treatment outcomes. Two text messaging methods will also be tested. One is to send text messages to remind participants of their goals (PUSH condition) and the second is to send text messages to remind participants to recall their goals (PULL condition). This study will be conducted within the context of an NICHD-funded Randomized Controlled Trial (grant number R01-HD071065; protocol registration ID NCT01828320). In R01-HD071065 adolescents ages 10-18 (n = 176) will receive either the Transdiagnostic Sleep and Circadian Intervention (TranS-C) or a Psychoeducation (PE). At the 6-month follow-up assessment for R01-HD071065, participants will be randomized using 3 (PUSH text messages, PULL text messages, or no text messages) x 2 (TranS-C or PE) design. At the 6-month follow-up assessment, a questionnaire will also be administered to establish baseline memory for treatment. Participants will be sent text messages once per week until they return for the 12 month follow-up assessment for R01-HD071065. At the 12 month follow-up assessment, participants will be asked to complete the same memory for treatment questionnaire completed at the 6 month follow-up assessment as well as a questionnaire evaluating the acceptability of the text message reminders. This research is a first step toward identifying whether an inexpensive and ubiquitous technology (i.e., text messaging) can improve memory for treatment.
- Conditions
- Sleep Wake Disorders
- Being tested
- PUSH text messages, PULL text messages, TranS-C, PE
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUSH text messagesOther
The intervention is designed to remind participants of treatment components.
PULL text messagesOther
The intervention is designed to remind participants to recall treatment components.
TranS-CBehavioural
Also called Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy
The Transdiagnostic Sleep and Circadian Intervention (TranS-C) integrates evidence-based treatments derived from basic research on the circadian system.
PEBehavioural
Also called Psychoeducation
Psychoeducation on the inter-associations between sleep, diet, exercise and stress.
| Study group | Role | What they receive |
|---|---|---|
| PUSH text messages | Experimental | Participants will be sent text messages containing information relevant to their treatment condition (i.e., TranS-C or PE). Receives: Other: PUSH text messages; Behavioral: TranS-C; Behavioral: PE |
| PULL text messages | Experimental | Participants will be sent text messages containing information relevant to their treatment condition (i.e., TranS-C or PE). Text messages will request a response from the participant. Receives: Other: PULL text messages; Behavioral: TranS-C; Behavioral: PE |
| No text messages | Other | No text messages will be sent in this condition to participants in either treatment condition (i.e., TranS-C or PE). Receives: Behavioral: TranS-C; Behavioral: PE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep time (TST) average on weeknights via Daily Sleep Diary
6mo TST
Measured: Measured at 6-months post-treatment
Total sleep time (TST) average on weeknights via Daily Sleep Diary
12mo TST
Measured: Measured at 12-months post-treatment
Average bedtime on weeknights measured via Daily Sleep Diary
6mo Avg Bedtime
Measured: Measured at 6-months post-treatment
Average bedtime on weeknights measured via Daily Sleep Diary
12mo Avg Bedtime
Measured: Measured at 12-months post-treatment
Morning Eveningness preference measured via Childrens Morningness Eveningness Preference Scale
6mo CME
Measured: Measured at 6-months post-treatment
Morning Eveningness preference measured via Childrens Morningness Eveningness Preference Scale
12mo CME
Measured: Measured at 12-months post-treatment
Patient Recall of Session Contents
6-12mo Change in Patient Recall
Measured: Change from 6-months post-treatment to 12-months post-treatment
Secondary outcomes (9)
Sleepiness scale
Embedded within the School Sleep Habits Survey
Measured: Measured at 6-months post-treatment
Sleepiness scale
Embedded within the School Sleep Habits Survey
Measured: Measured at 12-months post-treatment
Pittsburgh Sleep Quality Index
6mo PSQI
Measured: Measured at 6-months post-treatment
Pittsburgh Sleep Quality Index
12mo PSQI
Measured: Measured at 12-months post-treatment
Discrepancy between weeknights and weekends for Total Sleep Time, Bedtime, and Waketime via Daily Sleep Diary
6mo Weeknight-Weekend Differences
Measured: Measured at 6-months post-treatment
Discrepancy between weeknights and weekends for Total Sleep Time, Bedtime, and Waketime via Daily Sleep Diary
12mo Weeknight-Weekend Differences
Measured: Measured at 12-months post-treatment
Text Message Evaluation
Measure of the acceptability of receiving text messages
Measured: Measured at 12-months post-treatment
Child Behavior Checklist
Parent measure
Measured: Measured at 6-months post-treatment
Child Behavior Checklist
Parent measure
Measured: Measured at 12-months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startOct 2013
- Primary completionDec 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Wake DisordersStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 176 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 G Harvey, PhD, Principal investigator, University of California, BerkeleyMichael R Dolsen, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961400
- Sponsor's protocol ID
- 2012-02-4007_text_message
- Status last verified
- Oct 2019
- First submitted
- 17 Oct 2016
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Memory for Sleep Treatment Content With Text Messages
- ClinicalTrials.gov ID
- NCT02961400
- Acronym / sponsor ID
- 2012-02-4007_text_message
- Conditions
- Sleep Wake Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 11 Nov 2016 (estimated)
- 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.
A drop off in improvement over the months and years after treatment is common. One contributor may be poor memory for the contents of treatment. This study seeks to determine whether text messages containing reminders of the content of sessions will improve treatment outcomes.
Detailed description
The growth in the use of technology provides an opportunity to send reminders to participants via text messages. The early studies on text messaging interventions indicate this approach is enjoyable for participants and has positive effects across a range of domains and treatment types. Hence, this study will test whether text messages containing reminders of the content of sessions will improve treatment outcomes. Two text messaging methods will also be tested. One is to send text messages to remind participants of their goals (PUSH condition) and the second is to send text messages to remind participants to recall their goals (PULL condition). This study will be conducted within the context of an NICHD-funded Randomized Controlled Trial (grant number R01-HD071065; protocol registration ID NCT01828320). In R01-HD071065 adolescents ages 10-18 (n = 176) will receive either the Transdiagnostic Sleep and Circadian Intervention (TranS-C) or a Psychoeducation (PE). At the 6-month follow-up assessment for R01-HD071065, participants will be randomized using 3 (PUSH text messages, PULL text messages, or no text messages) x 2 (TranS-C or PE) design. At the 6-month follow-up assessment, a questionnaire will also be administered to establish baseline memory for treatment. Participants will be sent text messages once per week until they return for the 12 month follow-up assessment for R01-HD071065. At the 12 month follow-up assessment, participants will be asked to complete the same memory for treatment questionnaire completed at the 6 month follow-up assessment as well as a questionnaire evaluating the acceptability of the text message reminders. This research is a first step toward identifying whether an inexpensive and ubiquitous technology (i.e., text messaging) can improve memory for treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PUSH text messages | Experimental | Other: PUSH text messages, Behavioral: TranS-C, Behavioral: PEParticipants will be sent text messages containing information relevant to their treatment condition (i.e., TranS-C or PE). |
| PULL text messages | Experimental | Other: PULL text messages, Behavioral: TranS-C, Behavioral: PEParticipants will be sent text messages containing information relevant to their treatment condition (i.e., TranS-C or PE). Text messages will request a response from the participant. |
| No text messages | Other | Behavioral: TranS-C, Behavioral: PENo text messages will be sent in this condition to participants in either treatment condition (i.e., TranS-C or PE). |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Scoring within the lowest quartile of the Children's Morningness-Eveningness Preferences Scale (CMEP; 27 or lower) and a 7-day sleep diary showing a sleep onset time of of 10:40 pm or later for 10-13 year olds, 11 pm or later for 14-16 year olds, and 11:20 pm or later for 17-18 year olds at least 3 nights per week. Must have had the current pattern of late bedtimes for the last 3 months.
- 'At risk' in one of the five health domains: emotional, behavioral, social, physical, and cognitive. Emotional risk will be operationalized as a score of 4 or above on any of the following items on the Child Depression Rating Scale: Difficulty Having Fun, Social Withdrawal, Irritability, Depressed Feelings, Excessive Weeping, or a T-score of 61 or above on the Multidimensional Anxiety Scale for Children (MASC), based on age group (10-11 years, 12-15 year, 16-19 years) using the MASC-10 Profile. Behavioral risk will be operationalized as a Sensation Seeking Scale score greater than 3.93 for males ages 10-13, greater than 3.19 for females 10-13, greater than 4.07 for males 14-18, or greater than 3.19 for females 14-18; taking ADHD medication or Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADs) diagnosis of ADHD; current alcohol or substance abuse; or past alcohol or substance dependence. Social and cognitive risk will be defined as "worse" than others the teen's age in one or more social behavior from Child Behavior Checklist (CBCL) Section VI or failing one or more academic class from CBCL Section VII, respectively. Physical risk will be operationalized as a Physical Health Questionnaire-15 score of 4 or above, six or more days of school absences, or a BMI above the 85th percentile for the participant's sex and age.
- Age between 10 and 18 and living with a parent or guardian and and attending a class/job by 9am at least 3 days per week;
- English language fluency;
- Able and willing to give informed assent.
Key exclusion criteria (7 listed)
- An active, progressive physical illness (e.g., cancer, respiratory disorder) or neurological degenerative disease directly related to the onset and course of the sleep disturbance;
- Evidence from clinical diagnosis or report by youth or parent of sleep apnea, restless legs or periodic limb movements during sleep. Youth presenting with provisional diagnoses of any of these disorders (e.g., sleep apnea) will be referred for a non-study polysomnography (PSG) evaluation at the parent's discretion and will be enrolled only if the diagnosis is disconfirmed;
- Mental retardation, autism spectrum disorder, or other significantly impairing pervasive developmental disorder. Based on previous recruitment experiences in a youth depression study, it is expected that this exclusion will be invoked very infrequently (once every few years);
- Bipolar disorder or schizophrenia or another current Axis I disorder if there is a significant risk of harm and/or decompensation if treatment of that comorbid condition is delayed as a function of participating in any stage of this study. Otherwise, all other comorbid psychiatric conditions will be allowed to (i) to maximize representativeness and (ii) because a byproduct may be that the treatment constitutes a helpful 'transdiagnostic' treatment for youth across psychiatric disorders.
- A medication-free group may be difficult to recruit and would likely be unrepresentative. Hence, participants will not be excluded on the basis of stable use of medications (> 4 weeks). The exception was use of hypnotics and other medications known to alter sleep (e.g., melatonin).
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 |
|---|---|---|
| PUSH text messagesThe intervention is designed to remind participants of treatment components. | Other | PUSH text messages |
| PULL text messagesThe intervention is designed to remind participants to recall treatment components. | Other | PULL text messages |
| TranS-CAlso: Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, ChronotherapyThe Transdiagnostic Sleep and Circadian Intervention (TranS-C) integrates evidence-based treatments derived from basic research on the circadian system. | Behavioural | No text messages, PULL text messages, PUSH text messages |
| PEAlso: PsychoeducationPsychoeducation on the inter-associations between sleep, diet, exercise and stress. | Behavioural | No text messages, PULL text messages, PUSH text messages |
Primary outcome
Total sleep time (TST) average on weeknights via Daily Sleep Diary
Time frame: Measured at 6-months post-treatment
6mo TST
Total sleep time (TST) average on weeknights via Daily Sleep Diary
Time frame: Measured at 12-months post-treatment
12mo TST
Average bedtime on weeknights measured via Daily Sleep Diary
Time frame: Measured at 6-months post-treatment
6mo Avg Bedtime
Average bedtime on weeknights measured via Daily Sleep Diary
Time frame: Measured at 12-months post-treatment
12mo Avg Bedtime
Morning Eveningness preference measured via Childrens Morningness Eveningness Preference Scale
Time frame: Measured at 6-months post-treatment
6mo CME
Morning Eveningness preference measured via Childrens Morningness Eveningness Preference Scale
Time frame: Measured at 12-months post-treatment
12mo CME
Patient Recall of Session Contents
Time frame: Change from 6-months post-treatment to 12-months post-treatment
6-12mo Change in Patient Recall
9 secondary outcomes
Sleepiness scale
Time frame: Measured at 6-months post-treatment
Sleepiness scale
Time frame: Measured at 12-months post-treatment
Pittsburgh Sleep Quality Index
Time frame: Measured at 6-months post-treatment
Pittsburgh Sleep Quality Index
Time frame: Measured at 12-months post-treatment
Discrepancy between weeknights and weekends for Total Sleep Time, Bedtime, and Waketime via Daily Sleep Diary
Time frame: Measured at 6-months post-treatment
Discrepancy between weeknights and weekends for Total Sleep Time, Bedtime, and Waketime via Daily Sleep Diary
Time frame: Measured at 12-months post-treatment
Text Message Evaluation
Time frame: Measured at 12-months post-treatment
Child Behavior Checklist
Time frame: Measured at 6-months post-treatment
Child Behavior Checklist
Time frame: Measured at 12-months post-treatment
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 29 Oct 2019.
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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 G Harvey, PhD principal investigator
University of California, Berkeley
Michael R Dolsen 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 PUSH text messages, PULL text messages and TranS-C in people with Sleep Wake Disorders, 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 5 inclusion and 7 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 29 Oct 2019. 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?
Total sleep time (TST) average on weeknights via Daily Sleep Diary (time frame: Measured at 6-months post-treatment). 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?
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 29 Oct 2019.