Living Well With Stroke
Condition: Cerebrovascular Stroke; Depression
MeSH terms: Stroke; Depression
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Brief pleasurable events/behavioral therapy; Standard care
Intervention type(s): Behavioral; Other
Intervention description(s): 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.; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke recovery; quality of life