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Personalized Antidepressant Adherence Strategies For Depressed Elders (TIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01301859
Recruitment Status : Completed
First Posted : February 23, 2011
Last Update Posted : January 13, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Depression Behavioral: TIP

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Treatment Initiation and Participation Program (TIP)
Study Start Date : January 2011
Primary Completion Date : June 2016
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: TIP Adherence Intervention
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
Treatment visits as usual with MD
Placebo Comparator: Usual Care
Treatment as usual in a primary care setting
Behavioral: TIP
Treatment visits as usual with MD

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01301859

United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New York
Weil Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
University of Michigan
Principal Investigator: JoAnne Sirey, Ph.D. Weill Medical College of Cornell University
More Information

Responsible Party: Jo Anne Sirey, Associate Professor, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01301859     History of Changes
Other Study ID Numbers: 1R01MH087562-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jo Anne Sirey, Weill Medical College of Cornell University:
older adults

Additional relevant MeSH terms:
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs