Back to resultsTRIAD - Treatment of Insomnia and Depression
Primary Purpose
Sleep Initiation and Maintenance Disorders, Depression
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Antidepressant
Desensitization Therapy for Insomnia
Cognitive Behavioral Therapy for Insomnia
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders
Eligibility Criteria
Inclusion Criteria:
- Meets criteria for Major Depressive Disorder
- Between 18 and 75 years of age and adequately fluent in English
- Meets criteria for an insomnia disorder
Exclusion Criteria:
- Women who are currently pregnant, breast-feeding, or not using a reliable birth control method.
- People for whom the antidepressant medication(s) provided in the study is not indicated
- People who have had minimum adequate trials of (or have not been able to tolerate) all three study medications.
- People with uncontrolled medical conditions.
- People with moderate or severe sleep disorders other than insomnia
- Individuals on a fixed night shift or rotating work schedule that requires a night shift.
- Patients with a current principal diagnosis of a psychiatric disorder that necessitates treatment that is not offered in the study.
Sites / Locations
- Stanford University School of Medicine
- Duke University
- University of Pittsburgh
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
antidepressant + desensitization
antidepressant + cognitive behavioral
Arm Description
Combined antidepressant medication (determined by an algorithm) plus desensitization therapy
Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy
Outcomes
Primary Outcome Measures
Percent of Participants With Depression Remission
Depression remission was defined if both a and b below are satisfied
absence of both depressed mood and anhedonia for at least three consecutive weeks
no more than two other diagnostic criterion symptoms of depression met for at least three consecutive weeks
Secondary Outcome Measures
Percentage of Participants in Insomnia Remission
Remission was defined as endpoint ISI<8. The ISI scale score ranges from 0 to 28 with lower scores representing less severe insomnia. A score of 0-7 is interpreted as absence of insomnia.
Full Information
NCT ID
NCT00767624
First Posted
October 3, 2008
Last Updated
October 10, 2016
Sponsor
Stanford University
Collaborators
Duke University, University of Pittsburgh, University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT00767624
Brief Title
TRIAD - Treatment of Insomnia and Depression
Official Title
Improving Depression Outcome by Adding Insomnia Therapy to Antidepressants
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Duke University, University of Pittsburgh, University of Pennsylvania
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the proposed three-site study is to increase the rate of full remission from major depressive disorder (MDD) at the end of 16 weeks of treatment for people who experience both major depressive disorder and insomnia.
Detailed Description
Participants with major depressive disorder and insomnia who meet all study criteria will receive state-of-the-art antidepressant medications and one of two insomnia therapies. The specific therapy for insomnia will be determined by chance (like a flip of a coin), with an equal chance to receive either cognitive-behavioral therapy for insomnia or desensitization psychotherapy for insomnia. The study physician will select an initial antidepressant medication from a list of three possible medications . If that medication is not helpful, another medication may be tried after 8 weeks or in the event of severe side effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
antidepressant + desensitization
Arm Type
Other
Arm Description
Combined antidepressant medication (determined by an algorithm) plus desensitization therapy
Arm Title
antidepressant + cognitive behavioral
Arm Type
Other
Arm Description
Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy
Intervention Type
Drug
Intervention Name(s)
Antidepressant
Intervention Description
Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance
Intervention Type
Behavioral
Intervention Name(s)
Desensitization Therapy for Insomnia
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia
Primary Outcome Measure Information:
Title
Percent of Participants With Depression Remission
Description
Depression remission was defined if both a and b below are satisfied
absence of both depressed mood and anhedonia for at least three consecutive weeks
no more than two other diagnostic criterion symptoms of depression met for at least three consecutive weeks
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants in Insomnia Remission
Description
Remission was defined as endpoint ISI<8. The ISI scale score ranges from 0 to 28 with lower scores representing less severe insomnia. A score of 0-7 is interpreted as absence of insomnia.
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meets criteria for Major Depressive Disorder
Between 18 and 75 years of age and adequately fluent in English
Meets criteria for an insomnia disorder
Exclusion Criteria:
Women who are currently pregnant, breast-feeding, or not using a reliable birth control method.
People for whom the antidepressant medication(s) provided in the study is not indicated
People who have had minimum adequate trials of (or have not been able to tolerate) all three study medications.
People with uncontrolled medical conditions.
People with moderate or severe sleep disorders other than insomnia
Individuals on a fixed night shift or rotating work schedule that requires a night shift.
Patients with a current principal diagnosis of a psychiatric disorder that necessitates treatment that is not offered in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Manber
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30952216
Citation
Asarnow LD, Bei B, Krystal A, Buysse DJ, Thase ME, Edinger JD, Manber R. Circadian Preference as a Moderator of Depression Outcome Following Cognitive Behavioral Therapy for Insomnia Plus Antidepressant Medications: A Report From the TRIAD Study. J Clin Sleep Med. 2019 Apr 15;15(4):573-580. doi: 10.5664/jcsm.7716.
Results Reference
derived
PubMed Identifier
29504795
Citation
Bei B, Asarnow LD, Krystal A, Edinger JD, Buysse DJ, Manber R. Treating insomnia in depression: Insomnia related factors predict long-term depression trajectories. J Consult Clin Psychol. 2018 Mar;86(3):282-293. doi: 10.1037/ccp0000282.
Results Reference
derived
PubMed Identifier
27788313
Citation
Manber R, Buysse DJ, Edinger J, Krystal A, Luther JF, Wisniewski SR, Trockel M, Kraemer HC, Thase ME. Efficacy of Cognitive-Behavioral Therapy for Insomnia Combined With Antidepressant Pharmacotherapy in Patients With Comorbid Depression and Insomnia: A Randomized Controlled Trial. J Clin Psychiatry. 2016 Oct;77(10):e1316-e1323. doi: 10.4088/JCP.15m10244.
Results Reference
derived
Learn more about this trial
TRIAD - Treatment of Insomnia and Depression
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