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Psycho-Social Well Being Following Stroke

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02338869
Acronym
PsychoStroke
Enrollment
322
Registered
2015-01-14
Start date
2014-12-31
Completion date
2018-12-31
Last updated
2019-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Brief summary

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.

Interventions

BEHAVIORALDialogue-based psychosocial rehabilitation

Sponsors

Oslo University Hospital
CollaboratorOTHER
Sykehuset Innlandet HF
CollaboratorOTHER
University of Oslo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
General Health Questionnaire (GHQ 28)T2 (6 months poststroke)28 item general scale measuring emotional distress. Four subscales (somatic symptoms, anxiety/insomnia, social dysfunction and serious depression

Secondary

MeasureTime frameDescription
The Stroke and Aphasia Quality of Life scale (SAQOL-39)T2 (6 months poststroke)Disease-specific quality of life scale, measures patient's perspective of stroke's impact on 'physical', 'psychosocial' and 'communication' domains.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026