Living Well With Stroke "PSD2"

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Standard Care Behavioral
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Standard care
  • Brief pleasurable events/behavioral therapy Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: In-person behavioral intervention
    ARM 2: Kind: Experimental
    Label: Telephone behavioral intervention
    Description: This arm is identical to the in-person Arm except that the intervention is delivered by telephone instead of in-person.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

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 only difference in the two arms is one is given in person and the other is via the telephone.

Outcomes

Type Measure Time Frame Safety Issue
Primary Hamilton Rating Scale for Depression (HRSD) Remission is defined as an HRSD score of 9 or less on the 17 item scale
Secondary Stroke Impact Scale (SIS) The SIS has multiple scales measuring limitations in activity, in social participation and perceived overall stroke impact (perceived percent recovery)
Primary Hamilton Rating Scale for Depression (HRSD) 1 year post-treatment No
Secondary Stroke Impact Scale (SIS) 1 year post treatment No

Sponsors