NCT02943278

Brief Summary

In this study we are testing 2 different forms of sleep therapy to help people with insomnia and depression. As part of the study, you receive 1 of these 2 sleep therapies. We want to see how these sleep therapies help insomnia in people with depression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

1.9 years

First QC Date

October 21, 2016

Last Update Submit

July 25, 2018

Conditions

DepressionInsomnia

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Score of the Hamilton Depression Rating Scale at 8 weeks

    Clinician-rated depression symptom severity measure

    8 weeks after administration of intervention

Secondary Outcomes (1)

  • Change from Baseline Score of the Insomnia Severity Index at 8 weeks

    8 weeks after administration of intervention

Study Arms (2)

Sleep Hygiene Group

PLACEBO COMPARATOR

Participants assigned to the sleep hygiene group you have 1 session with a clinician to learn about different things they can do to improve their sleep.

Behavioral: Sleep Hygiene

Intensive Sleep Retraining Group

ACTIVE COMPARATOR

Participants assigned to this group will spend just over 1 day at our sleep lab, starting around your usual bedtime and ending the following day. Over a 20 hour period participants will complete a sleep retraining session, which involves an opportunity to fall asleep every 30 minutes; we will wake the participant up after a few minutes if they fall asleep.

Behavioral: Intensive Sleep Retraining

Interventions

Intensive Sleep RetrainingBEHAVIORAL

Participants in this group you will spend just over 1 day at our sleep lab, starting around their usual bedtime and ending the following day. Over a 20 hour period participants will complete a sleep retraining session, which involves an opportunity to fall asleep every 30 minutes; we will wake participants up after a few minutes if they fall asleep.

Intensive Sleep Retraining Group
Sleep HygieneBEHAVIORAL

Participants in this group will complete one session with a clinician focused on psychoeducation regarding sleep positive practices.

Sleep Hygiene Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Experiencing depression
  • Experiencing chronic insomnia
  • Have been taking an antidepressant medication at a stable dose for at least 8 weeks, and willing to stay on a stable dose for the duration of the study. This medication must be prescribed by a doctor at the University of Michigan. OR not taking any antidepressants and you do not plan to start taking any antidepressants over the next 9 weeks.

You may not qualify if:

  • Have psychiatric conditions or sleep disorders other than depression or insomnia
  • Have a chronic medical condition that could negatively affect your sleep or mood
  • Are currently receiving treatment for insomnia (such as prescription or over-the-counter medications, or other therapies)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

DepressionSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Leslie Swanson, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

October 21, 2016

First Posted

October 24, 2016

Study Start

August 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

July 26, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)