View Clinical Trial (Medical Research Study)
Psychosocial/Behavioral Intervention in Post-Stroke Depression (PSD)
| City: |
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Seattle |
| State: |
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Washington |
| Zip Code: |
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98195 |
| Conditions: |
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Cerebrovascular Stroke - Depression |
| Purpose: |
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The overall goal of this study is to conduct a three-armed randomized controlled trial (RCT)
in stroke survivors with depression to determine if a brief psychosocial-behavioral therapy
intervention delivered in-person (arm A) or by telephone (arm B) is better than usual care
(arm C), in terms of percent reduction in depressive symptoms and % of participants
achieving remission of symptoms.
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| Study Summary: |
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This is the second phase of a study whose aim was to evaluate the short and long-term
efficacy of a brief psychosocial/behavioral intervention (with adjunctive antidepressant)for
the treatment of post-stroke depression (PSD) in survivors of ischemic stroke (registered as
clinical trail NCT00194454). In the earlier trial we demonstrated that a pleasant
event/problem-solving brief psychosocial-behavioral therapy delivered by psychosocial nurse
practitioners was highly effective in treating major depression and promoting remission in
ischemic stroke survivors for up to two years. In this phase, we refine the protocol, and
potentially make it more cost effective, by conducting a randomized comparative
effectiveness trial of in-person versus telephone delivery of the intervention, comparing
with usual care control. We also seek to expand our sample to include hemorrhagic stroke
survivors (intraparenchymal hemorrhage and subarachnoid hemorrhage) as well as those with
ischemic stroke.
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| Criteria: |
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Inclusion Criteria:
- hospitalized for an ischemic or hemorrhagic stroke (intraparenchymal hemorrhage- IPH
or subarachnoid hemorrhage - SAH) in the past 3 months
- clinical depression symptoms (Geriatric Depression Score -GDS >= 11
Exclusion Criteria:
- major psychiatric co-morbidity
- active suicidal ideation without ability to contract for safety
- current substance abuse
- physical inability to tolerate 1-2 hour sessions
- receptive or global aphasia
- reduced level of consciousness (GCS<15).
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| NCT ID: |
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NCT01133106 |
| Primary Contact: |
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Principal Investigator
Pamela H Mitchell, PhD
University of Washington
Catherine J Kirkness, PhD
Phone: 206 221-7971
Email: kirkness@u.washington.edu
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| Backup Contact: |
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Email: buzzie@u.washington.edu
Ann Buzaitis, MN
Phone: 206 685-5178
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| Location Contact: |
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Seattle, Washington 98195
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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