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TRIAD - Treatment of Insomnia and Depression

NCT ID: NCT00767624

Last Updated: 2016-12-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2015-06-30

Brief Summary

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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

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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.

Conditions

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Sleep Initiation and Maintenance Disorders Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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antidepressant + desensitization

Combined antidepressant medication (determined by an algorithm) plus desensitization therapy

Group Type OTHER

Antidepressant

Intervention Type DRUG

Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance

Desensitization Therapy for Insomnia

Intervention Type BEHAVIORAL

antidepressant + cognitive behavioral

Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy

Group Type OTHER

Antidepressant

Intervention Type DRUG

Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance

Cognitive Behavioral Therapy for Insomnia

Intervention Type BEHAVIORAL

Interventions

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Antidepressant

Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance

Intervention Type DRUG

Desensitization Therapy for Insomnia

Intervention Type BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Meets criteria for Major Depressive Disorder
2. Between 18 and 75 years of age and adequately fluent in English
3. Meets criteria for an insomnia disorder

Exclusion Criteria

1. Women who are currently pregnant, breast-feeding, or not using a reliable birth control method.
2. People for whom the antidepressant medication(s) provided in the study is not indicated
3. People who have had minimum adequate trials of (or have not been able to tolerate) all three study medications.
4. People with uncontrolled medical conditions.
5. People with moderate or severe sleep disorders other than insomnia
6. Individuals on a fixed night shift or rotating work schedule that requires a night shift.
7. Patients with a current principal diagnosis of a psychiatric disorder that necessitates treatment that is not offered in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Rachel Manber

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rachel Manber

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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Spina MA, Bei B, Rajaratnam SW, Krystal A, Edinger JD, Buysse DJ, Thase M, Manber R. Cognitive behavioural therapy for insomnia reduces actigraphy and diary measured sleep discrepancy for individuals with comorbid insomnia and major depressive disorder: A report from the TRIAD study. Sleep Med. 2024 Feb;114:137-144. doi: 10.1016/j.sleep.2023.12.014. Epub 2023 Dec 24.

Reference Type DERIVED
PMID: 38183804 (View on PubMed)

Edinger JD, Smith ED, Buysse DJ, Thase M, Krystal AD, Wiskniewski S, Manber R. Objective sleep duration and response to combined pharmacotherapy and cognitive behavioral insomnia therapy among patients with comorbid depression and insomnia: a report from the TRIAD study. J Clin Sleep Med. 2023 Jun 1;19(6):1111-1120. doi: 10.5664/jcsm.10514.

Reference Type DERIVED
PMID: 36798983 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30952216 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29504795 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27788313 (View on PubMed)

Other Identifiers

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MH78924

Identifier Type: -

Identifier Source: secondary_id

SU-08132008-1277

Identifier Type: -

Identifier Source: org_study_id