TRIAD - Treatment of Insomnia and Depression

• ClinicalTrials.gov Identifier: NCT00767624
• Recruitment Status: Completed
• First Posted: October 7, 2008
• Results First Posted: December 5, 2016
• Last Update Posted: December 5, 2016
• Sponsor: Stanford University
• Collaborators: Duke University; University of Pittsburgh; University of Pennsylvania
• Information provided by (Responsible Party): Rachel Manber, Stanford University

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.

Condition or disease	Intervention/treatment	Phase
Sleep Initiation and Maintenance Disorders; Depression	Drug: Antidepressant; Behavioral: Desensitization Therapy for Insomnia; Behavioral: Cognitive Behavioral Therapy for Insomnia	Phase 2; Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Improving Depression Outcome by Adding Insomnia Therapy to Antidepressants
• Study Start Date: December 2008
• Actual Primary Completion Date: June 2015
• Actual Study Completion Date: June 2015

Arms and Interventions

Arm	Intervention/treatment
antidepressant + desensitization; Combined antidepressant medication (determined by an algorithm) plus desensitization therapy	Drug: Antidepressant; Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance; Behavioral: Desensitization Therapy for Insomnia
antidepressant + cognitive behavioral; Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy	Drug: Antidepressant; Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance; Behavioral: Cognitive Behavioral Therapy for Insomnia

Outcome Measures

Primary Outcome Measures :

1. Percent of Participants With Depression Remission [ Time Frame: 16 weeks ]

   Depression remission was defined if both a and b below are satisfied

   1. absence of both depressed mood and anhedonia for at least three consecutive weeks
   2. no more than two other diagnostic criterion symptoms of depression met for at least three consecutive weeks

Secondary Outcome Measures :

1. Percentage of Participants in Insomnia Remission [ Time Frame: 16 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, California

Stanford University School of Medicine

Stanford, California, United States, 94305

United States, North Carolina

Duke University

Durham, North Carolina, United States

United States, Pennsylvania

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Sponsors and Collaborators

Stanford University

Duke University

University of Pittsburgh

University of Pennsylvania

Investigators

• Principal Investigator: Rachel Manber; Stanford University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

• Responsible Party: Rachel Manber, Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT00767624
• Other Study ID Numbers: SU-08132008-1277; MH78924
• First Posted: October 7, 2008
• Results First Posted: December 5, 2016
• Last Update Posted: December 5, 2016
• Last Verified: October 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders; Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Antidepressive Agents; Psychotropic Drugs