Living Well With Stroke (PSD2)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Pamela Mitchell, University of Washington
ClinicalTrials.gov Identifier:
NCT01133106
First received: May 26, 2010
Last updated: May 29, 2014
Last verified: May 2014
  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)

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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: December 2014
Estimated Primary Completion Date: December 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
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01133106

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195-7266
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Pamela H Mitchell, PhD University of Washington
Principal Investigator: Catherine J Kirkness, PhD University of Washington
  More Information

Publications:
Responsible Party: Pamela Mitchell, Professor, School of Nursing, 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 29, 2014
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 July 20, 2014