Living Well With Stroke (PSD2)

University of Washington

Status: Completed

Conditions: Cerebrovascular Stroke; Depression

Treatments: Other: Standard care; Behavioral: Brief pleasurable events/behavioral therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01133106

R01NR007755 (U.S. NIH Grant/Contract)

37952-J

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 21 to 100 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 3 patient groups

In-person behavioral intervention

Experimental group

Description:

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

Treatment:

Behavioral: Brief pleasurable events/behavioral therapy

Telephone behavioral intervention

Experimental group

Description:

This arm is identical to the in-person Arm except that the intervention is delivered by telephone instead of in-person.

Treatment:

Behavioral: Brief pleasurable events/behavioral therapy

Standard care

Active Comparator group

Description:

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

Treatment:

Other: Standard care