Sleep to Prevent Evolving Affecting Disorders

Depression Clinical Trial

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Official title:

Sleep to Prevent Evolving Affecting Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02988375
• Other study ID #: 10320
• Status: Completed
• Phase: N/A
• Start date: March 8, 2016
• Est. completion date: September 13, 2018

Study information

• Verified date: January 2024
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1385
• Est. completion date: September 13, 2018
• Est. primary completion date: April 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Insomnia, Primary
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• dCBTI

• Sleep Education

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Pre-Treatment	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)
Primary	Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Post-Treatment	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)
Primary	Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS), 1-year Follow-up	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)
Primary	Severity of Symptoms of Insomnia [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	Severity of Symptoms of Insomnia - Post Treatment	Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)	Post-treatment (~6 week after Screening)
Secondary	Severity of Symptoms of Insomnia - 1 Year Post Treatment	Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)	1-year follow-up (58 week after screening)