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Completed

NCT Number: NCT01133106

Living Well With Stroke

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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Key information

Conditions

Cerebrovascular Stroke Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Depression Nervous System Diseases Stroke Vascular Diseases

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98195-7266, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Brief pleasurable events/behavioral therapy

Behavioral

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.

Standard care

Other

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

Primary outcomes

  1. 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 outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Psychosocial/Behavioral Intervention in Post-Stroke Depression (PSD)

Acronym: PSD2

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
May 28, 2010
Registry last updated
May 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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