Improving Memory for Sleep Treatment Content With Text Messages

NCT02961400 | Completed DMC

• 1 other identifier: 2012-02-4007_text_message
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Wake Disorders

Outcome Measures

Primary Outcomes (7)

• Total sleep time (TST) average on weeknights via Daily Sleep Diary

  6mo TST

  Measured at 6-months post-treatment

• Total sleep time (TST) average on weeknights via Daily Sleep Diary

  12mo TST

  Measured at 12-months post-treatment

• Average bedtime on weeknights measured via Daily Sleep Diary

  6mo Avg Bedtime

  Measured at 6-months post-treatment

• Average bedtime on weeknights measured via Daily Sleep Diary

  12mo Avg Bedtime

  Measured at 12-months post-treatment

• Morning Eveningness preference measured via Childrens Morningness Eveningness Preference Scale

  6mo CME

  Measured at 6-months post-treatment

• Morning Eveningness preference measured via Childrens Morningness Eveningness Preference Scale

  12mo CME

  Measured at 12-months post-treatment

• Patient Recall of Session Contents

  6-12mo Change in Patient Recall

  Change from 6-months post-treatment to 12-months post-treatment

Secondary Outcomes (9)

• Sleepiness scale

  Measured at 6-months post-treatment

• Sleepiness scale

  Measured at 12-months post-treatment

• Pittsburgh Sleep Quality Index

  Measured at 6-months post-treatment

• Pittsburgh Sleep Quality Index

  Measured at 12-months post-treatment

• Discrepancy between weeknights and weekends for Total Sleep Time, Bedtime, and Waketime via Daily Sleep Diary

  Measured at 6-months post-treatment

Other Outcomes (4)

• Useful and Utilized Questionnaire

  Measured at 6-months post-treatment

• Useful and Utilized Questionnaire

  Measured at 12-months post-treatment

• Daily Sleep Diary

  Measured at 6-months post-treatment

Study Arms (3)

PUSH text messages

EXPERIMENTAL

Participants will be sent text messages containing information relevant to their treatment condition (i.e., TranS-C or PE).

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.

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).

Behavioral: TranS-C; Behavioral: PE

Interventions

PUSH text messages OTHER

The intervention is designed to remind participants of treatment components.

PUSH text messages

PULL text messages OTHER

The intervention is designed to remind participants to recall treatment components.

PULL text messages

TranS-C BEHAVIORAL

The Transdiagnostic Sleep and Circadian Intervention (TranS-C) integrates evidence-based treatments derived from basic research on the circadian system.

Also known as: Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy

No text messages; PULL text messages; PUSH text messages

PE BEHAVIORAL

Psychoeducation on the inter-associations between sleep, diet, exercise and stress.

Also known as: Psychoeducation

No text messages; PULL text messages; PUSH text messages

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• University of California, Berkeley: lead

Study Sites (1)

University of California, Berkeley

Berkeley, California, 94720, United States

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Interventions

Cognitive Behavioral Therapy; Chronotherapy

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Therapeutics

Study Officials

• Allison G Harvey, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

• Michael R Dolsen

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychology

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: November 11, 2016
• Study Start: October 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: October 29, 2019

Record last verified: 2019-10

Locations

US (1)