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TRIAD - Treatment of Insomnia and Depression

This study has been completed.
Sponsor:
Collaborators:
Duke University
University of Pittsburgh
University of Pennsylvania
Information provided by (Responsible Party):
Rachel Manber, Stanford University
ClinicalTrials.gov Identifier:
NCT00767624
First received: October 3, 2008
Last updated: October 10, 2016
Last verified: October 2016
Results First Received: August 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Sleep Initiation and Maintenance Disorders
Depression
Interventions: Drug: Antidepressant
Behavioral: Desensitization Therapy for Insomnia
Behavioral: Cognitive Behavioral Therapy for Insomnia

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Antidepressant + Desensitization

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

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

Desensitization Therapy for Insomnia

Antidepressant + Cognitive Behavioral

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

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

Cognitive Behavioral Therapy for Insomnia


Participant Flow:   Overall Study
    Antidepressant + Desensitization   Antidepressant + Cognitive Behavioral
STARTED   75   75 
COMPLETED   51   58 
NOT COMPLETED   24   17 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat

Reporting Groups
  Description
Antidepressant + Desensitization

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

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

Desensitization Therapy for Insomnia

Antidepressant + Cognitive Behavioral

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

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

Cognitive Behavioral Therapy for Insomnia

Total Total of all reporting groups

Baseline Measures
   Antidepressant + Desensitization   Antidepressant + Cognitive Behavioral   Total 
Overall Participants Analyzed 
[Units: Participants]
 75   75   150 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.0  (12.3)   48.3  (12.7)   46.6  (12.6) 
Gender 
[Units: Participants]
     
Female   57   53   110 
Male   18   22   40 
Insomnia Severity Index (ISI) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 18.3  (3.9)   19.4  (4.3)   18.9  (4.1) 
[1] The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28, with larger numbers representing greater severity. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8- 14); moderate insomnia (15-21); and severe insomnia (22-28).
Hamilton Rating Scale for Depression (HRSD) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 21.5  (3.7)   21.9  (3.8)   21.7  (3.7) 
[1] The HRSD is a 17-item semi-structured interview assessing the severity of depression in the past week. Items are rated on a 3 or 5 point scale. The total score is the sum of individual items, yielding a total score ranging from 0 to 52, with larger numbers representing greater severity. The total score is interpreted as follows: absence of depression (0-7); mild depression (8- 16); moderate depression (17-23); and severe depression (24-52).


  Outcome Measures
  Show All Outcome Measures

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Our results do not inform clinical guidelines for any single antidepressant medication.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Rachel Manber, PhD
Organization: STANFORD UNIVERSITY
phone: 6504981266
e-mail: rmanber@stanford.edu



Responsible Party: Rachel Manber, Stanford University
ClinicalTrials.gov Identifier: NCT00767624     History of Changes
Other Study ID Numbers: SU-08132008-1277
MH78924
Study First Received: October 3, 2008
Results First Received: August 5, 2016
Last Updated: October 10, 2016
Health Authority: United States: Institutional Review Board