Overview

This trial is active, not recruiting.

Condition depression
Treatment tip
Sponsor Weill Medical College of Cornell University
Collaborator National Institute of Mental Health (NIMH)
Start date January 2011
End date June 2016
Trial size 260 participants
Trial identifier NCT01301859, 1R01MH087562-01A1

Summary

The study is a randomized controlled trial to test the usefulness of a brief intervention to improve adherence to antidepressant medication prescribed to older adults in a primary care setting. Study will be conducted at Weill Cornell and University of Michigan.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
Arm
(Active Comparator)
The TIP program is a brief, individualized intervention designed as an adjunct to pharmacotherapy for depression prescribed by a primary care physician. The key to the intervention is the involvement of the older adult in creating an adherence strategy tailored to his/her barriers and needs.
tip
Treatment visits as usual with MD
(Placebo Comparator)
Treatment as usual in a primary care setting
tip
Treatment visits as usual with MD

Primary Outcomes

Measure
Brief Medication Questionnaire
time frame: 12 week Follow up

Secondary Outcomes

Measure
Hamilton Depression Rating Scale
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 65 years old.

Inclusion Criteria: Age: 65 and older; Newly prescribed antidepressant medication by PCP (within past 10 days); Has not been prescribed antidepressant medication in previous 6 months. Exclusion Criteria: High suicide risk, i.e. intent or plan to attempt suicide Presence of alcohol abuse, substance abuse, psychotic disorder or, bipolar disorder as observed on the SCID, are excluded; Dementia: MMSE below 24, clinical assessment, or medication; Inability to speak English; Aphasia interfering with communication; Terminal illness or current chemotherapy

Additional Information

Official title Treatment Initiation and Participation Program (TIP)
Principal investigator JoAnne Sirey, Ph.D.
Description The intervention is a brief, psychosocial intervention designed to be an adjunct to pharmacotherapy prescribed by a primary care physician. It includes psychoeducation, problem solving and development of goals and a personalized adherence strategy. The intervention includes three 30 minute sessions during the first 6 weeks of treatment and a follow-up phone call two weeks later.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Weill Medical College of Cornell University.