Skip to main content
OpenTrials
Completed

NCT Number: NCT02988375

Sleep to Prevent Evolving Affecting Disorders

The primary objective of the proposed research is to determine the efficacy of Digital Cognitive Behavior Therapy (dCBTI) in reducing severity of depression and also in preventing the incidence and relapse of depression among insomniacs. In addition, we will identify salient sociological/environmental variables, such as age, sex, education, socioeconomic status (SES), racial/ethnic minority-status, work schedule, child-care responsibilities (i.e., having children under the age of 3), stigma, that moderate the effects of this intervention.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Insomnia, Primary Behavior Behavioral Symptoms Depression Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

About this study

The purpose of this study is to determine the effectiveness of Digital Cognitive Behavior Therapy for Insomnia (dCBTI) in reducing severity of depression and also in preventing the incidence and relapse of depression among insomniacs. dCBTI is an online form of Cognitive Behavioral Therapy (CBT) used with people who experience trouble sleeping at night (insomniacs). This study will allow us to determine whether this form of digital therapy is helpful in reducing the severity of depression and in preventing the development and relapse of depression in people suffering from insomnia.

Participants will be recruited from several well-developed sources, including the HFHS Sleep Center Clinical database. Once a participant meets inclusion criteria and provides consent, a link to the internet portal will be provided to complete the remaining survey questions. After completion of this assessment, participants will be automatically randomized to one of 2 active online insomnia treatment conditions. Each treatment involves 6 weekly "sessions" which each take up to 20 minutes to complete.

A post-treatment questionnaire immediately following the 6-week treatment phase will be completed. In addition, a follow up questionnaire assessment will be completed approximately 1 year after treatment. Each of the 3 separate questionnaires will take 20-30 minutes to complete. Participants will be compensated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meets Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition(DSMV) criteria for insomnia

Exclusion criteria

  • Lack of insomnia, untreated sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome), bipolar disorder, history of seizure disorder, high depression chronicity (self-reported daily or near daily depressed mood and anhedonia)

Treatment and study plan

dCBTI

Behavioral

Sleep Education

Behavioral

Primary outcomes

  1. Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Pre-Treatment

    Time frame: Pre-treatment (Day 1)

    Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity) and incidence of depression

  2. Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Post-Treatment

    Time frame: Post-treatment (~6 week after Screening)

    Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity)

  3. Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS), 1-year Follow-up

    Time frame: 1-year follow-up (58 week after screening)

    Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity)

  4. Severity of Symptoms of Insomnia [Time Frame: Pre-treatment (Day 1)]

    Time frame: Pre-treatment (Day 1)

    Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)

Secondary outcomes

  1. Severity of Symptoms of Insomnia - Post Treatment

    Time frame: Post-treatment (~6 week after Screening)

    Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)

  2. Severity of Symptoms of Insomnia - 1 Year Post Treatment

    Time frame: 1-year follow-up (58 week after screening)

    Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • Robert Wood Johnson Foundation

Registry information

Acronym: SPREAD

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 9, 2016
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.