Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

PERSONALIZED ANTIDEPRESSANT ADHERENCE STRATEGIES FOR DEPRESSED ELDERS (TIP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
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 10, 2015
Last verified: December 2015
  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: June 2016
Estimated Primary Completion Date: June 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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Investigators
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 
Study First Received: February 18, 2011
Last Updated: December 10, 2015
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
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on December 07, 2016