PERSONALIZED ANTIDEPRESSANT ADHERENCE STRATEGIES FOR DEPRESSED ELDERS (TIP)
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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) |
- 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.
- 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 |
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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Contacts and Locations| Contact: Patricia Marino, PhD | 914-997-8691 | pam2029@med.cornell.edu |
| 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 | |
| Principal Investigator: | JoAnne Sirey, Ph.D. | Weill Medical College of Cornell University |
More Information
No publications provided
| Responsible Party: | Jo Anne Sirey, PhD, Weill Cornell Medical College |
| ClinicalTrials.gov Identifier: | NCT01301859 History of Changes |
| Other Study ID Numbers: | 1R01MH087562-01A1 |
| Study First Received: | February 18, 2011 |
| Last Updated: | February 18, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
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 May 19, 2013