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Completed

NCT Number: NCT01301859

Personalized Antidepressant Adherence Strategies For Depressed Elders

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

TIP

Behavioral

Treatment visits as usual with MD

Primary outcomes

  1. Brief Medication Questionnaire

    Time frame: 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 outcomes

  1. Hamilton Depression Rating Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of Michigan

Registry information

Official study title

Treatment Initiation and Participation Program (TIP)

Acronym: TIP

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Feb 23, 2011
Registry last updated
Jan 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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