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Living Well With Stroke (PSD2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01133106
First Posted: May 28, 2010
Last Update Posted: May 23, 2016
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.
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Pamela Mitchell, University of Washington
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Psychosocial/Behavioral Intervention in Post-Stroke Depression (PSD)

Further study details as provided by Pamela Mitchell, University of Washington:

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression (HRSD) [ Time Frame: 1 year post-treatment ]
    Remission is defined as an HRSD score of 9 or less on the 17 item scale


Secondary Outcome Measures:
  • Stroke Impact Scale (SIS) [ Time Frame: 1 year post treatment ]
    The SIS has multiple scales measuring limitations in activity, in social participation and perceived overall stroke impact (perceived percent recovery)


Enrollment: 100
Study Start Date: May 2010
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: In-person behavioral intervention
behavioral counseling plus antidepressant treatment prescribed by participant's own provider; consisted of orientation session plus 6 counseling sessions in person with a psychosocial nurse practitioner
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
participants have orientation to the study with the same written materials given those in the experimental arms. Keep a medication log and keep appointments with their own post-stroke provider
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01133106


Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195-7266
Sponsors and Collaborators
University of Washington
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Pamela H Mitchell, PhD University of Washington
Principal Investigator: Catherine J Kirkness, PhD University of Washington
  More Information

Publications:
Kirkness, CJ, Buzaitis, A, Habermann, B, Jessup, NM, McClennon, SM, McKenzie, S, Weaver, M, Weisman, P, Mitchell PH, Bakas, T. (2014) Methodological issues in telephone interventions for stroke survivors and family caregivers. Abstract 86. Stroke. 45(Suppl_1) (Supplement 1):A86, February 2014
Kirkness CJ, Becker KJ, Cain KC, Kohen, R, Tirschwell, DL, Teri L, Veith RR, Mitchell PH (2015) Telephone versus in-person psychosocial behavioral treatment in post-stroke depression. Abstract WP:125. Stroke 46 (supplement 1): WP 125, February 2015. http://stroke.ahajournals.org/content/46/Suppl_1/AWP125.abstract?sid=441a6914-e14e-4969-85f9-964367d56ed7

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pamela Mitchell, Professor, School of Nursing, University of Washington
ClinicalTrials.gov Identifier: NCT01133106     History of Changes
Other Study ID Numbers: 37952-J
R01NR007755 ( U.S. NIH Grant/Contract )
First Submitted: May 26, 2010
First Posted: May 28, 2010
Last Update Posted: May 23, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: de-identified data will be provided to qualified investigators, including students conducting secondary analysis

Keywords provided by Pamela Mitchell, University of Washington:
stroke recovery
quality of life

Additional relevant MeSH terms:
Stroke
Depression
Depressive Disorder
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs