Psycho-Social Well Being Following Stroke "PsychoStroke"

Recruiting

Phase N/A Results N/A

Trial Description

Multicenter randomized controlled trial (RCT) testing the effect of a dialogue-based psychosocial intervention for stroke acute survivors in primary care one to six months poststroke. Primary outcome is psycho-social health and wellbeing, measured by GHQ28 (primary outcome) and SAQoL (secondary outcome). 400 stroke survivors are randomized into intervention group or control group. Patients are followed up for 12 months.

Conditions

Interventions

  • Dialogue-based psychosocial rehabilitation Behavioral
    ARM 1: Kind: Experimental
    Label: Dialogue-based psychosocial intervention
    Description: Participants receive six individual meetings with trained health care professional in additional to usual rehabilitation and care. Dialogues focus on individual psychosocial challenges and needs and provide emotional and informational support to encourage and facilitate coping.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary General Health Questionnaire (GHQ 28) T2 (6 months poststroke) No
Secondary The Stroke and Aphasia Quality of Life scale (SAQOL-39) T2 (6 months poststroke) No

Sponsors