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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
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

Tracking Information
First Submitted Date  ICMJE February 18, 2011
First Posted Date  ICMJE February 23, 2011
Last Update Posted Date January 13, 2017
Study Start Date  ICMJE January 2011
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2011)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Personalized Antidepressant Adherence Strategies For Depressed Elders
Official Title  ICMJE Treatment Initiation and Participation Program (TIP)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Depression
Intervention  ICMJE Behavioral: TIP
Treatment visits as usual with MD
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: TIP
  • Placebo Comparator: Usual Care
    Treatment as usual in a primary care setting
    Intervention: Behavioral: TIP
Publications * Sirey JA, Banerjee S, Marino P, Bruce ML, Halkett A, Turnwald M, Chiang C, Liles B, Artis A, Blow F, Kales HC. Adherence to Depression Treatment in Primary Care: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Nov 1;74(11):1129-1135. doi: 10.1001/jamapsychiatry.2017.3047.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2017)
231
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2011)
260
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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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Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01301859
Other Study ID Numbers  ICMJE 1R01MH087562-01A1( U.S. NIH Grant/Contract )
1R01MH087562-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jo Anne Sirey, Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE
  • National Institute of Mental Health (NIMH)
  • University of Michigan
Investigators  ICMJE
Principal Investigator: JoAnne Sirey, Ph.D. Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date January 2017

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