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PERSONALIZED ANTIDEPRESSANT ADHERENCE STRATEGIES FOR DEPRESSED ELDERS (TIP)

This study is currently recruiting participants. (see Contacts and Locations)
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

February 18, 2011
December 16, 2013
January 2011
January 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01301859 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
PERSONALIZED ANTIDEPRESSANT ADHERENCE STRATEGIES FOR DEPRESSED ELDERS
Treatment Initiation and Participation Program (TIP)

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Depression
Behavioral: TIP
Treatment visits as usual with MD
  • 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.
    Intervention: Behavioral: TIP
  • Placebo Comparator: Usual Care
    Treatment as usual in a primary care setting
    Intervention: Behavioral: TIP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
260
January 2016
January 2016   (final data collection date for primary outcome measure)

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

-

Both
65 Years and older
No
Contact: Patricia Marino, PhD 914-997-8691 pam2029@med.cornell.edu
United States
 
NCT01301859
1R01MH087562-01A1, 1R01MH087562-01A1
Yes
Jo Anne Sirey, Weill Medical College of Cornell University
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
Weill Medical College of Cornell University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP