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Completed

NCT Number: NCT02338869

Psycho-Social Well Being Following Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University hospital

Oslo, Norway

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • being adults (over 18 years old),
  • suffered an acute stroke within the last month,
  • medically stable,
  • sufficient cognitive functioning to participate (assessed by their physician/stroke team and acceptable Raven's score (see below),
  • interested in participating,
  • able to understand and speak Norwegian, and
  • able to give informed consent.

Exclusion criteria

  • moderate to severe dementia or other serious disease.

Persons with aphasia will be examined by a speech therapist and excluded if they have significant impressive aphasia or severe expressive aphasia inconsistent with participating in the dialogues.

Treatment and study plan

Dialogue-based psychosocial rehabilitation

Behavioral

Primary outcomes

  1. General Health Questionnaire (GHQ 28)

    Time frame: T2 (6 months poststroke)

    28 item general scale measuring emotional distress. Four subscales (somatic symptoms, anxiety/insomnia, social dysfunction and serious depression

Secondary outcomes

  1. The Stroke and Aphasia Quality of Life scale (SAQOL-39)

    Time frame: T2 (6 months poststroke)

    Disease-specific quality of life scale, measures patient's perspective of stroke's impact on 'physical', 'psychosocial' and 'communication' domains.

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Oslo University Hospital
  • Sykehuset Innlandet HF

Registry information

Official study title

Psycho-Social Well Being Following Stroke - A Randomized Controlled Trial

Acronym: PsychoStroke

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 14, 2015
Registry last updated
Mar 6, 2019

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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