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POst Stroke Intervention Trial In Fatigue (POSITIF)

NCT03551327 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2024-05-13

No results posted yet for this study

Summary

The purpose of this study is to assess whether a brief cognitive behavioural intervention for post-stroke fatigue leads to clinically relevant improvements in fatigue after 6 months.

Conditions

  • Post-stroke Fatigue

Interventions

BEHAVIORAL

Experimental: Intervention plus information

The intervention will include six sessions with a therapist, each separated by two weeks. During the two weeks between sessions, participants will work on the goals identified during the sessions. At the final session, the participants will agree how to maintain any improvements in fatigue. Then there will be a review phone call about 4-6 weeks after completion of the intervention, to check on progress and to offer ongoing encouragement to continue with the changes that have been made during the intervention. The intervention can be delivered by video conferencing as well as by phone.

OTHER

Active Comparator: Information only

Participants in this arm will be provided with information about fatigue.

Sponsors & Collaborators

  • University of Leeds

    collaborator OTHER

  • The George Institute for Global Health, Australia

    collaborator OTHER

  • University College London Hospitals

    collaborator OTHER

  • University of Edinburgh

    lead OTHER

Principal Investigators

  • Gillian Mead, MB BChir MA MD FRCP · University of Edinburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-19
Primary Completion
2020-01-20
Completion
2021-07-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03551327 on ClinicalTrials.gov