Personalized Antidepressant Adherence Strategies For Depressed Elders

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: TIP

• Registration Number: NCT01301859
• Lead Sponsor: Weill Medical College of Cornell University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-18
• Study First Submitted QC: 2011-02-18
• Study First Posted: 2011-02-23
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	TIP	Treatment as usual in a primary care setting
TIP Adherence Intervention	TIP	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.

Primary Outcome Measures

Name	Time	Method
Brief Medication Questionnaire	12 week Follow up	Participants randomized to the TIP intervention will be significantly more likely to be adherent (take more than 80% of prescribed doses) to antidepressant treatment at 6-week follow-up (immediately after the intervention is completed) and 12-week follow-up (6 weeks after intervention is completed) as compared to older adults randomized to the Treatment as usual control condition.

Secondary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale	12 weeks	Participants randomized to the TIP intervention will have a significantly greater reduction of depressive symptoms (on the HDRS) from baseline to the 6-week, 12-week and 24-week follow-ups than older adults who are randomized to the treatment as usual control condition.

Trial Locations

Locations (2)

Weil Cornell Medical College; 🇺🇸 New York, New York, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States