Personalized Antidepressant Adherence Strategies For Depressed Elders

NCT01301859 | Completed DMC

• 1 other identifier: 1R01MH087562-01A1
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression

Keywords

older adults; adherence; antidepressant; depression

Outcome Measures

Primary Outcomes (1)

• Brief Medication Questionnaire

  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.

  12 week Follow up

Secondary Outcomes (1)

• Hamilton Depression Rating Scale

  12 weeks

Study Arms (2)

TIP Adherence Intervention

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.

Behavioral: TIP

Usual Care

PLACEBO COMPARATOR

Treatment as usual in a primary care setting

Behavioral: TIP

Interventions

TIP BEHAVIORAL

Treatment visits as usual with MD

TIP Adherence Intervention; Usual Care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age: 65 and older; Newly prescribed antidepressant medication by PCP (within past 10 days); Has not been prescribed antidepressant medication in previous 6 months.

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute of Mental Health (NIMH): collaborator
• University of Michigan: collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Weil Cornell Medical College

New York, New York, 10065, United States

Location

Related Publications (1)

• Sirey JA, Banerjee S, Marino P, Bruce ML, Halkett A, Turnwald M, Chiang C, Liles B, Artis A, Blow F, Kales HC. Adherence to Depression Treatment in Primary Care: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Nov 1;74(11):1129-1135. doi: 10.1001/jamapsychiatry.2017.3047.

  PMID: 28973066 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• JoAnne Sirey, Ph.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: February 23, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 13, 2017

Record last verified: 2017-01

Locations

US (2)