PERSONALIZED ANTIDEPRESSANT ADHERENCE STRATEGIES FOR DEPRESSED ELDERS (TIP)

This study is currently recruiting participants.
Verified December 2013 by Weill Medical College of Cornell University
Sponsor:
Collaborators:
University of Michigan
Information provided by (Responsible Party):
Jo Anne Sirey, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01301859
First received: February 18, 2011
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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 Intervention
Depression
Behavioral: TIP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Treatment Initiation and Participation Program (TIP)

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Brief Medication Questionnaire [ Time Frame: 12 week Follow up ] [ Designated as safety issue: No ]
    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:
  • Hamilton Depression Rating Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 260
Study Start Date: January 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TIP Adherence Intervension
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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301859

Contacts
Contact: Patricia Marino, PhD 914-997-8691 pam2029@med.cornell.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Devon Newman    734-232-0385    devonn@med.umich.edu   
Principal Investigator: Helen Kales, MD         
United States, New York
Weil Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Patricia Marino, PhD    914-997-8691    pam2029@med.cornell.edu   
Principal Investigator: Jo Anne Sirey, PhD         
Sponsors and Collaborators
Weill Medical College of Cornell University
University of Michigan
Investigators
Principal Investigator: JoAnne Sirey, Ph.D. Weill Medical College of Cornell University
  More Information

No publications provided

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, 1R01MH087562-01A1
Study First Received: February 18, 2011
Last Updated: December 16, 2013
Health Authority: United States: Federal Government

Keywords provided by Weill Medical College of Cornell University:
older adults
adherence
antidepressant
depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014