Trial Outcomes & Findings for Preventing Depression in Late Life: A Model for Low and Middle Income Countries (NCT NCT02145429)

NCT ID: NCT02145429

Last Updated: 2019-01-24

Results Overview

Cumulative incidence of episodes of major depression and anxiety disorders over a 12-month period measured by MINI

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 181 participants
• Primary outcome timeframe: One year
• Results posted on: 2019-01-24

Participant Flow

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

Participant milestones

Measure	Problem Solving Therapy + Behavioral Treatment of Insomnia 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.	Enhanced Usual Care Care as usual with scheduled assessments of clinical status
Overall Study STARTED	91	90
Overall Study COMPLETED	75	79
Overall Study NOT COMPLETED	16	11

Reasons for withdrawal

Measure	Problem Solving Therapy + Behavioral Treatment of Insomnia 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.	Enhanced Usual Care Care as usual with scheduled assessments of clinical status
Overall Study Death	4	5
Overall Study Lost to Follow-up	4	3
Overall Study Withdrawal by Subject	8	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Problem Solving Therapy + Behavioral Treatment of Insomnia n=91 Participants 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.	Enhanced Usual Care n=90 Participants Care as usual with scheduled assessments of clinical status	Total n=181 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	91 Participants n=5 Participants	90 Participants n=7 Participants	181 Participants n=5 Participants
Age, Continuous	69.6 years STANDARD_DEVIATION 7.1 • n=5 Participants	69.7 years STANDARD_DEVIATION 7.3 • n=7 Participants	69.6 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	57 Participants n=7 Participants	114 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	33 Participants n=7 Participants	67 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	91 Participants n=5 Participants	90 Participants n=7 Participants	181 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment India	91 Participants n=5 Participants	90 Participants n=7 Participants	181 Participants n=5 Participants

PRIMARY outcome

Timeframe: One year

Cumulative incidence of episodes of major depression and anxiety disorders over a 12-month period measured by MINI

Outcome measures

Measure	Problem Solving Therapy + Behavioral Treatment of Insomnia n=75 Participants 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.	Enhanced Usual Care n=79 Participants Care as usual with scheduled assessments of clinical status
Percent of Participants Who Develop Major Depression and Anxiety Disorders	4 Participants	13 Participants

PRIMARY outcome

Timeframe: One year

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

Outcome measures

Measure	Problem Solving Therapy + Behavioral Treatment of Insomnia n=75 Participants 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.	Enhanced Usual Care n=79 Participants Care as usual with scheduled assessments of clinical status
General Health Questionnaire (GHQ) Scores	3.67 score on a scale Standard Deviation 2.67	5.67 score on a scale Standard Deviation 3.19

SECONDARY outcome

Timeframe: One year

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.

Outcome measures

Measure	Problem Solving Therapy + Behavioral Treatment of Insomnia n=75 Participants 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.	Enhanced Usual Care n=79 Participants Care as usual with scheduled assessments of clinical status
World Health Organization Disability Assessment Schedule (WHODAS-II) Scores	16.72 score on a scale Standard Deviation 5.71	17.73 score on a scale Standard Deviation 6.27

Adverse Events

Problem Solving Therapy + Behavioral Treatment of Insomnia

Serious events: 19 serious events

Other events: 0 other events

Deaths: 4 deaths

Enhanced Usual Care

Serious events: 5 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Measure	Problem Solving Therapy + Behavioral Treatment of Insomnia n=91 participants at risk 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.	Enhanced Usual Care n=90 participants at risk Care as usual with scheduled assessments of clinical status
Surgical and medical procedures Medical or Surgical Hospitalization	20.9% 19/91 • Number of events 19 • One Year	5.6% 5/90 • Number of events 5 • One Year

Other adverse events

Adverse event data not reported

Additional Information

Charles F. Reynolds, MD

University of Pittsburgh

Phone: (412) 246-6414

Email: reynoldscf@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place