Improving Memory for Sleep Treatment Content With Text Messages

Sleep Wake Disorders Clinical Trial

Official title:

Improving Memory for Sleep Treatment Content With Text Messages

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02961400
• Other study ID #: 2012-02-4007_text_message
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: December 2018

Study information

• Verified date: October 2019
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

1. 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.

2. '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.

3. 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;

4. English language fluency;

5. Able and willing to give informed assent.

Exclusion Criteria:

1. 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;

2. 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;

3. 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);

4. 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.

5. 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).

6. History of substance dependence in the past six months;

7. Current suicide risk sufficient to preclude treatment on an outpatient basis.

Related Conditions & MeSH terms

• Parasomnias
• Sleep Wake Disorders

Intervention

Other:
• PUSH text messages
The intervention is designed to remind participants of treatment components.
• PULL text messages
The intervention is designed to remind participants to recall treatment components.

Behavioral:
• TranS-C
The Transdiagnostic Sleep and Circadian Intervention (TranS-C) integrates evidence-based treatments derived from basic research on the circadian system.
• PE
Psychoeducation on the inter-associations between sleep, diet, exercise and stress.

Locations

Country	Name	City	State
United States	University of California, Berkeley	Berkeley	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Berkeley

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Useful and Utilized Questionnaire	6mo UUQ	Measured at 6-months post-treatment
Other	Useful and Utilized Questionnaire	12mo UUQ	Measured at 12-months post-treatment
Other	Daily Sleep Diary	total sleep time (weekend nights), weeknight bedtime, weekend risetime, total wake time (SOL+WASO) weeknights, total wake time (SOL+WASO) weekend nights, naps.	Measured at 6-months post-treatment
Other	Daily Sleep Diary	total sleep time (weekend nights), weeknight bedtime, weekend risetime, total wake time (SOL+WASO) weeknights, total wake time (SOL+WASO) weekend nights, naps.	Measured at 12-months post-treatment
Primary	Total sleep time (TST) average on weeknights via Daily Sleep Diary	6mo TST	Measured at 6-months post-treatment
Primary	Total sleep time (TST) average on weeknights via Daily Sleep Diary	12mo TST	Measured at 12-months post-treatment
Primary	Average bedtime on weeknights measured via Daily Sleep Diary	6mo Avg Bedtime	Measured at 6-months post-treatment
Primary	Average bedtime on weeknights measured via Daily Sleep Diary	12mo Avg Bedtime	Measured at 12-months post-treatment
Primary	Morning Eveningness preference measured via Childrens Morningness Eveningness Preference Scale	6mo CME	Measured at 6-months post-treatment
Primary	Morning Eveningness preference measured via Childrens Morningness Eveningness Preference Scale	12mo CME	Measured at 12-months post-treatment
Primary	Patient Recall of Session Contents	6-12mo Change in Patient Recall	Change from 6-months post-treatment to 12-months post-treatment
Secondary	Sleepiness scale	Embedded within the School Sleep Habits Survey	Measured at 6-months post-treatment
Secondary	Sleepiness scale	Embedded within the School Sleep Habits Survey	Measured at 12-months post-treatment
Secondary	Pittsburgh Sleep Quality Index	6mo PSQI	Measured at 6-months post-treatment
Secondary	Pittsburgh Sleep Quality Index	12mo PSQI	Measured at 12-months post-treatment
Secondary	Discrepancy between weeknights and weekends for Total Sleep Time, Bedtime, and Waketime via Daily Sleep Diary	6mo Weeknight-Weekend Differences	Measured at 6-months post-treatment
Secondary	Discrepancy between weeknights and weekends for Total Sleep Time, Bedtime, and Waketime via Daily Sleep Diary	12mo Weeknight-Weekend Differences	Measured at 12-months post-treatment
Secondary	Text Message Evaluation	Measure of the acceptability of receiving text messages	Measured at 12-months post-treatment
Secondary	Child Behavior Checklist	Parent measure	Measured at 6-months post-treatment
Secondary	Child Behavior Checklist	Parent measure	Measured at 12-months post-treatment