Living Well With Stroke (PSD2)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Cerebrovascular Stroke Depression |
Behavioral: Brief pleasurable events/behavioral therapy Other: Standard care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Psychosocial/Behavioral Intervention in Post-Stroke Depression (PSD) |
- Hamilton Rating Scale for Depression (HRSD) [ Time Frame: 1 year post-treatment ] [ Designated as safety issue: No ]Remission is defined as an HRSD score of 9 or less on the 17 item scale
- Stroke Impact Scale (SIS) [ Time Frame: 1 year post treatment ] [ Designated as safety issue: No ]The SIS has multiple scales measuring limitations in activity, in social participation and perceived overall stroke impact (perceived percent recovery)
| Estimated Enrollment: | 225 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: In-person behavioral intervention |
Behavioral: Brief pleasurable events/behavioral therapy
Each participant in any arm will be given an American Stroke Association article about stroke and depression, a Stroke Smart Article about caregiver depression, and a pamphlet by the Beck Institute titled "Coping with Depression". Each participant in Arms 1 and 2 will be given their own manual for the intervention sessions. The intervention consists of one in-person orientation session and 6 weekly sessions with the following topics introducing behavioral therapy, the role of pleasant events, problem-solving skills and generalization techniques. All participants' primary care provider or stroke care provider will receive a letter informing them of their patient's participation (but not of study assignment). This letter will include recommendations for prescribing and adjusting antidepressant treatment using established guidelines adapted for treatment of medically-ill outpatients. |
|
Experimental: Telephone behavioral intervention
This arm is identical to the in-person Arm except that the intervention is delivered by telephone instead of in-person.
|
Behavioral: Brief pleasurable events/behavioral therapy
Each participant in any arm will be given an American Stroke Association article about stroke and depression, a Stroke Smart Article about caregiver depression, and a pamphlet by the Beck Institute titled "Coping with Depression". Each participant in Arms 1 and 2 will be given their own manual for the intervention sessions. The intervention consists of one in-person orientation session and 6 weekly sessions with the following topics introducing behavioral therapy, the role of pleasant events, problem-solving skills and generalization techniques. All participants' primary care provider or stroke care provider will receive a letter informing them of their patient's participation (but not of study assignment). This letter will include recommendations for prescribing and adjusting antidepressant treatment using established guidelines adapted for treatment of medically-ill outpatients. |
| Active Comparator: Standard care |
Other: Standard care
The standard care group (Arm C, N=75) will receive standard medical treatment from their provider, including a recommendation for antidepressants. Participants or third-party payers will pay for their antidepressants, just as they would under regular care. All participants receive written materials regarding depression from the American Stroke Association, keep medication logs and receive follow-up assessment on the same time frame as the intervention groups
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations| Contact: Catherine J Kirkness, PhD | 206 221-7971 | kirkness@u.washington.edu |
| Contact: Ann Buzaitis, MN | 206 685-5178 | buzzie@u.washington.edu |
| United States, Washington | |
| University of Washington | Recruiting |
| Seattle, Washington, United States, 98195-7266 | |
| Principal Investigator: Pamela H Mitchell, PhD | |
| Principal Investigator: Catherine J Kirkness, PhD | |
| Principal Investigator: | Pamela H Mitchell, PhD | University of Washington |
| Principal Investigator: | Catherine J Kirkness, PhD | University of Washington |
More Information
Publications:
| Responsible Party: | Pamela H. Mitchell, Principal Investigator (contact), University of Washington |
| ClinicalTrials.gov Identifier: | NCT01133106 History of Changes |
| Other Study ID Numbers: | 37952-J, 2R01NR007755-06 |
| Study First Received: | May 26, 2010 |
| Last Updated: | May 26, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Washington:
|
stroke recovery quality of life |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Stroke Cerebral Infarction Behavioral Symptoms Mood Disorders Mental Disorders Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 23, 2013