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Sleep to Prevent Evolving Affecting Disorders (SPREAD)

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ClinicalTrials.gov Identifier: NCT02988375
Recruitment Status : Completed
First Posted : December 9, 2016
Last Update Posted : October 31, 2018
Sponsor:
Collaborator:
Robert Wood Johnson 1R56MH115150-01
Information provided by (Responsible Party):
Christopher Drake, Henry Ford Health System

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Insomnia, Primary Depression Behavioral: dCBTI Behavioral: Sleep Education Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1385 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Sleep to Prevent Evolving Affecting Disorders
Actual Study Start Date : March 8, 2016
Actual Primary Completion Date : April 26, 2018
Actual Study Completion Date : September 13, 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Severity of Depression [ 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. Prevention of Incident Depression (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. Prevention of Depression Relapse 1-years Post Treatment [ 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)


Secondary Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988375


Locations
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United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Robert Wood Johnson 1R56MH115150-01
Investigators
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Principal Investigator: Christopher Drake, PhD Henry Ford Medical Center - Columbus

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Responsible Party: Christopher Drake, Director of Sleep Research, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT02988375     History of Changes
Other Study ID Numbers: 10320
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Christopher Drake, Henry Ford Health System:
insomnia
depression
digital CBTI
online CBTI

Additional relevant MeSH terms:
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Depression
Sleep Initiation and Maintenance Disorders
Behavioral Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders