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Trial record 86 of 5357 for:    "Depressive Disorder" [DISEASE] AND Behavioral

Preventing Depression in Late Life: A Model for Low and Middle Income Countries

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ClinicalTrials.gov Identifier: NCT02145429
Recruitment Status : Completed
First Posted : May 22, 2014
Results First Posted : January 24, 2019
Last Update Posted : January 24, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Goa Medical College
Sangath
Information provided by (Responsible Party):
Charles Reynolds, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Depression
Anxiety Disorder
Intervention Behavioral: Problem Solving therapy and Brief Behavioral Treatment of Insomnia
Enrollment 181
Recruitment Details Because enrollment exceeded expectations, we were able to increase sample size from the original n proposed (120) to 181, thereby allowing us to carry out a fully powered confirmatory RCT. We obtained NIMH permission to change from an intervention development study to an RCT
Pre-assignment Details  
Arm/Group Title Problem Solving Therapy + Behavioral Treatment of Insomnia Enhanced Usual Care
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Problem Solving Therapy + Brief Behavioral Treatment of Insomnia as needed

Problem Solving therapy and Brief Behavioral Treatment of Insomnia: Problem Solving therapy teaches problem solving skills that participants can use in their everyday life. A problem is identified, various solutions identified and explored with the underlying focus to learn behavioral and self management strategies.Social casework and management of chronic disease is also included as per the participant's need.

Brief Behavioral Treatment of Insomnia focuses on improving sleep by promoting sleep hygiene such as time spent in bed and decreasing night time stimuli. The therapy has been suitably modified to suit the needs of the participants to be recruited in the Low and Middle income countries keeping in mind the low level of literacy and the local social and health care services.

Care as usual with scheduled assessments of clinical status
Period Title: Overall Study
Started 91 90
Completed 75 79
Not Completed 16 11
Reason Not Completed
Death             4             5
Lost to Follow-up             4             3
Withdrawal by Subject             8             3
Arm/Group Title Problem Solving Therapy + Behavioral Treatment of Insomnia Enhanced Usual Care Total
Hide Arm/Group Description

Problem Solving Therapy + Brief Behavioral Treatment of Insomnia as needed

Problem Solving therapy and Brief Behavioral Treatment of Insomnia: Problem Solving therapy teaches problem solving skills that participants can use in their everyday life. A problem is identified, various solutions identified and explored with the underlying focus to learn behavioral and self management strategies.Social casework and management of chronic disease is also included as per the participant's need.

Brief Behavioral Treatment of Insomnia focuses on improving sleep by promoting sleep hygiene such as time spent in bed and decreasing night time stimuli. The therapy has been suitably modified to suit the needs of the participants to be recruited in the Low and Middle income countries keeping in mind the low level of literacy and the local social and health care services.

Care as usual with scheduled assessments of clinical status Total of all reporting groups
Overall Number of Baseline Participants 91 90 181
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 90 participants 181 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
91
 100.0%
90
 100.0%
181
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 91 participants 90 participants 181 participants
69.6  (7.1) 69.7  (7.3) 69.6  (7.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 90 participants 181 participants
Female
57
  62.6%
57
  63.3%
114
  63.0%
Male
34
  37.4%
33
  36.7%
67
  37.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 90 participants 181 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
91
 100.0%
90
 100.0%
181
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
India Number Analyzed 91 participants 90 participants 181 participants
91
 100.0%
90
 100.0%
181
 100.0%
[1]
Measure Description: All participants were recruited from Goa, India
1.Primary Outcome
Title Percent of Participants Who Develop Major Depression and Anxiety Disorders
Hide Description Cumulative incidence of episodes of major depression and anxiety disorders over a 12-month period measured by MINI
Time Frame One year
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Problem Solving Therapy + Behavioral Treatment of Insomnia Enhanced Usual Care
Hide Arm/Group Description:

Problem Solving Therapy + Brief Behavioral Treatment of Insomnia as needed

Problem Solving therapy and Brief Behavioral Treatment of Insomnia: Problem Solving therapy teaches problem solving skills that participants can use in their everyday life. A problem is identified, various solutions identified and explored with the underlying focus to learn behavioral and self management strategies.Social casework and management of chronic disease is also included as per the participant's need.

Brief Behavioral Treatment of Insomnia focuses on improving sleep by promoting sleep hygiene such as time spent in bed and decreasing night time stimuli. The therapy has been suitably modified to suit the needs of the participants to be recruited in the Low and Middle income countries keeping in mind the low level of literacy and the local social and health care services.

Care as usual with scheduled assessments of clinical status
Overall Number of Participants Analyzed 75 79
Measure Type: Count of Participants
Unit of Measure: Participants
4
   5.3%
13
  16.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Problem Solving Therapy + Behavioral Treatment of Insomnia, Enhanced Usual Care
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.32
Confidence Interval (2-Sided) 95%
0.10 to 0.98
Estimation Comments [Not Specified]
2.Primary Outcome
Title General Health Questionnaire (GHQ) Scores
Hide Description Levels of depressive and anxiety symptoms. Scores on the General Health Questionnaire (GHQ-12) range from 0 to 12; a higher score indicated greater symptoms for depression and anxiety
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Problem Solving Therapy + Behavioral Treatment of Insomnia Enhanced Usual Care
Hide Arm/Group Description:

Problem Solving Therapy + Brief Behavioral Treatment of Insomnia as needed

Problem Solving therapy and Brief Behavioral Treatment of Insomnia: Problem Solving therapy teaches problem solving skills that participants can use in their everyday life. A problem is identified, various solutions identified and explored with the underlying focus to learn behavioral and self management strategies.Social casework and management of chronic disease is also included as per the participant's need.

Brief Behavioral Treatment of Insomnia focuses on improving sleep by promoting sleep hygiene such as time spent in bed and decreasing night time stimuli. The therapy has been suitably modified to suit the needs of the participants to be recruited in the Low and Middle income countries keeping in mind the low level of literacy and the local social and health care services.

Care as usual with scheduled assessments of clinical status
Overall Number of Participants Analyzed 75 79
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.67  (2.67) 5.67  (3.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Problem Solving Therapy + Behavioral Treatment of Insomnia, Enhanced Usual Care
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.18
Confidence Interval (2-Sided) 95%
-2.03 to -0.31
Estimation Comments [Not Specified]
3.Secondary Outcome
Title World Health Organization Disability Assessment Schedule (WHODAS-II) Scores
Hide Description Assessment instrument for health and disability or functional status. Scores on the World Health Organization Disability Assessment Schedule (WHODAS 2.0) range from 12 to 60; a higher score indicated greater disability.
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Problem Solving Therapy + Behavioral Treatment of Insomnia Enhanced Usual Care
Hide Arm/Group Description:

Problem Solving Therapy + Brief Behavioral Treatment of Insomnia as needed

Problem Solving therapy and Brief Behavioral Treatment of Insomnia: Problem Solving therapy teaches problem solving skills that participants can use in their everyday life. A problem is identified, various solutions identified and explored with the underlying focus to learn behavioral and self management strategies.Social casework and management of chronic disease is also included as per the participant's need.

Brief Behavioral Treatment of Insomnia focuses on improving sleep by promoting sleep hygiene such as time spent in bed and decreasing night time stimuli. The therapy has been suitably modified to suit the needs of the participants to be recruited in the Low and Middle income countries keeping in mind the low level of literacy and the local social and health care services.

Care as usual with scheduled assessments of clinical status
Overall Number of Participants Analyzed 75 79
Mean (Standard Deviation)
Unit of Measure: score on a scale
16.72  (5.71) 17.73  (6.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Problem Solving Therapy + Behavioral Treatment of Insomnia, Enhanced Usual Care
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-1.89 to 1.62
Estimation Comments [Not Specified]
Time Frame One Year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Problem Solving Therapy + Behavioral Treatment of Insomnia Enhanced Usual Care
Hide Arm/Group Description

Problem Solving Therapy + Brief Behavioral Treatment of Insomnia as needed

Problem Solving therapy and Brief Behavioral Treatment of Insomnia: Problem Solving therapy teaches problem solving skills that participants can use in their everyday life. A problem is identified, various solutions identified and explored with the underlying focus to learn behavioral and self management strategies.Social casework and management of chronic disease is also included as per the participant's need.

Brief Behavioral Treatment of Insomnia focuses on improving sleep by promoting sleep hygiene such as time spent in bed and decreasing night time stimuli. The therapy has been suitably modified to suit the needs of the participants to be recruited in the Low and Middle income countries keeping in mind the low level of literacy and the local social and health care services.

Care as usual with scheduled assessments of clinical status
All-Cause Mortality
Problem Solving Therapy + Behavioral Treatment of Insomnia Enhanced Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   4/91 (4.40%)      5/90 (5.56%)    
Show Serious Adverse Events Hide Serious Adverse Events
Problem Solving Therapy + Behavioral Treatment of Insomnia Enhanced Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/91 (20.88%)      5/90 (5.56%)    
Surgical and medical procedures     
Medical or Surgical Hospitalization *  19/91 (20.88%)  19 5/90 (5.56%)  5
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Problem Solving Therapy + Behavioral Treatment of Insomnia Enhanced Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/91 (0.00%)      0/90 (0.00%)    
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: Charles F. Reynolds, MD
Organization: University of Pittsburgh
Phone: (412) 246-6414
Responsible Party: Charles Reynolds, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02145429     History of Changes
Other Study ID Numbers: 1R34MH096997-01A1 ( U.S. NIH Grant/Contract )
First Submitted: May 20, 2014
First Posted: May 22, 2014
Results First Submitted: December 20, 2018
Results First Posted: January 24, 2019
Last Update Posted: January 24, 2019