Sleep to Prevent Evolving Affecting Disorders (SPREAD)

January 11, 2024 updated by: Christopher Drake, Henry Ford Health System
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

1385

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dCBTI
Online access to the digital CBTI program Sleepio
Behavioral: dCBTI
Placebo Comparator: Sleep Education
Weekly email messages with sleep hygiene recommendations
Behavioral: Sleep Education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pre-treatment (Day 1)
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)
Post-treatment (~6 week after Screening)
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)
1-year follow-up (58 week after screening)
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)
Pre-treatment (Day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Post-treatment (~6 week after Screening)
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)
1-year follow-up (58 week after screening)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Collaborators

Robert Wood Johnson Foundation

Investigators

  • Principal Investigator: Christopher Drake, PhD, Henry Ford Medical Center - Columbus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2016

Primary Completion (Actual)

April 26, 2018

Study Completion (Actual)

September 13, 2018

Study Registration Dates

First Submitted

December 7, 2016

First Submitted That Met QC Criteria

December 8, 2016

First Posted (Estimated)

December 9, 2016

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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