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Adapted Solution Focused Therapy for People With Aphasia (SOFIA Trial) (SOFIA)

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ClinicalTrials.gov Identifier: NCT03245060
Recruitment Status : Recruiting
First Posted : August 10, 2017
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
City, University of London

Brief Summary:
Around one third of stroke survivors will have aphasia, which means they will have difficulty talking, understanding, reading or writing. The main aims of this study are to assess: [1] the acceptability of an existing psychosocial intervention, solution focused brief therapy, to people with varying presentations of aphasia; and [2] the feasibility of conducting a future definitive trial investigating clinical and cost effectiveness.

Condition or disease Intervention/treatment Phase
Aphasia Stroke Behavioral: Adapted Solution Focused Brief Therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Wait-list control feasibility study with nested qualitative research.

Participants will be randomly assigned to the intervention group or wait-list control group. Both groups will be assessed on psychosocial outcome measures at T1 (baseline, prior to randomisation), T2 (three months post randomisation) and T3 (six months post randomisation). Participants will also take part in in-depth interviews at T3 exploring their experiences of taking part in the project as well as complete a resource use questionnaire. All participants will receive all usual care, and up to six SFBT sessions spaced over three months delivered by Speech and Language Therapists (SLTs). The intervention group will receive the therapy immediately post randomisation, while the wait-list control group will be offered the intervention after T3. The wait-list control will additionally be reassessed at T4 (nine months post randomisation).

Masking: Single (Outcomes Assessor)
Masking Description: The Research Assistant will complete the psychosocial outcome measures at all time points in face to face interview format. The Research Assistant will be blinded to treatment allocation.
Primary Purpose: Treatment
Official Title: Adapted Solution Focused Brief Therapy in Post-stroke Aphasia (SOFIA Trial): a Feasibility Study
Actual Study Start Date : October 17, 2017
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
Experimental: Intervention: immediate SFBT
The Intervention arm will receive up to six Adapted Solution Focused Brief Therapy (SFBT) sessions immediately post randomisation. The sessions will be spaced over 3 months. Participants will also receive all usual care.
Behavioral: Adapted Solution Focused Brief Therapy
Solution Focused Brief Therapy is an approach to building positive change in a person's life. It builds up a picture of a client's preferred future (or how a person would like their life to be); encourages a person to notice positive signs of change; and explores personal resources, skills and resilience. In the present project, the therapy has been adapted so that it works well with people who have a language disability.

Intervention: delayed SFBT
The wait-list control arm will receive the same intervention (Adapted Solution Focused Brief Therapy, SFBT) as the intervention arm, but after a delay of six months. Participants will also receive all usual care.
Behavioral: Adapted Solution Focused Brief Therapy
Solution Focused Brief Therapy is an approach to building positive change in a person's life. It builds up a picture of a client's preferred future (or how a person would like their life to be); encourages a person to notice positive signs of change; and explores personal resources, skills and resilience. In the present project, the therapy has been adapted so that it works well with people who have a language disability.




Primary Outcome Measures :
  1. Warwick Edinburgh Mental Well-being Scale (WEMWBS) [ Time Frame: 6 months post randomization ]
    Measures mental well-being. 14 items, scores range from 14 to 70, with higher scores indicating greater overall mental well-being


Secondary Outcome Measures :
  1. Warwick Edinburgh Mental Well-being Scale (WEMWBS) - measuring change [ Time Frame: All participants will complete WEMWBS at baseline, pre-randomization (T1), 3 months post randomization (T2), 6 months post randomization (T3). The wait-list control arm will also be tested at 9 months post randomization (T4). ]
    Measures mental well-being. 14 items, scores range from 14 to 70, with higher scores indicating greater overall mental well-being

  2. General Health Questionnaire-12 (GHQ-12) - measuring change [ Time Frame: All participants will complete GHQ-12 at baseline, pre-randomisation (T1), 3 months post randomisation (T2), 6 months post randomisation (T3). The wait-list control arm will also be tested at 9 months post randomisation (T4). ]
    Measures psychological distress. 12 items, scores range from 0 to 12 with higher scores indicating greater levels of distress

  3. Communicative Participation Item Bank (CPIB) - measuring change [ Time Frame: All participants will complete CPIB at baseline, pre-randomisation (T1), 3 months post randomisation (T2), 6 months post randomisation (T3). The wait-list control arm will also be tested at 9 months post randomisation (T4). ]
    Measures communicative participation. 10 items, scores range from 0 to 30 with higher scores indicating communication difficulties interfere less with participation

  4. Depression Intensity Scale Circles (DISCS) - measuring change [ Time Frame: All participants will complete DISCS at baseline, pre-randomisation (T1), 3 months post randomisation (T2), 6 months post randomisation (T3). The wait-list control arm will also be tested at 9 months post randomisation (T4). ]
    Measures depression. Single item scale, scores range from 0 to 5, with a score 0-1 indicating no/low distress, and 5 high distress; designed to be accessible to people with cognitive or communicative deficits.


Other Outcome Measures:
  1. European Quality of Life - 5 dimensions, 5 levels (EQ-5D-5L) - measuring change [ Time Frame: All participants will complete EQ-5D-5L at baseline, pre-randomisation (T1), 3 months post randomisation (T2), 6 months post randomisation (T3). The wait-list control arm will also be tested at 9 months post randomization (T4). ]
    Measures generic health status; the first part of the measure contains 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) that are rated on 5 levels (from no problems to extreme problems). The second part is a Visual Analogue Scale where a person self-rates their health. The EQ-5D-5L will be used to measure quality adjusted life years (QALYs) gained in each group.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Have a diagnosis of ischaemic or haemorrhagic stroke
  • At least six months post stroke
  • 18 years old or over
  • Presenting with aphasia as a result of the stroke. For those participants identified via United Kingdom National Health Service (two participant identification centers), this will be determined based on Speech and Language Therapist diagnosis. For participants recruited via the community, it will be based on their scores on the Frenchay Aphasia Screening Test (FAST). This test covers four major aspects of language: comprehension, expression, reading and writing. Aphasia is determined by published cut-off scores. Where a person has mild aphasia, such that they score as 'normal' on the FAST, but where the participant self-identifies as having aphasia, and this is confirmed by the clinical judgement of the Chief Investigator, they will be included.

Exclusion Criteria:

  • Other diagnoses affecting cognition such as dementia or advanced Parkinson's Disease
  • Severe uncorrected visual or hearing problems that would impact on a person's capacity to take part in the intervention
  • Severe or potentially terminal co-morbidity on grounds of frailty
  • Currently receiving a psychological or psychiatric intervention
  • Non-fluent English speaker prior to the stroke based on self/family report
  • Do not have mental capacity to consent to take part in the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245060


Contacts
Contact: Sarah Northcott, PhD +44 020 7 040 3186 sarah.northcott@city.ac.uk
Contact: Katerina Hilari, PhD +44 020 7 040 4660 k.hilari@city.ac.uk

Locations
United Kingdom
City, University of London Recruiting
London, United Kingdom, EC1V 0HB
Contact: Sarah Northcott, PhD    +44 207 040 3186    sarah.northcott@city.ac.uk   
Contact: Katerina Hilari, PhD    +44 207 040 4660    k.hilari@city.ac.uk   
Sponsors and Collaborators
City, University of London
Investigators
Principal Investigator: Sarah Northcott, PhD City, University of London

Responsible Party: City, University of London
ClinicalTrials.gov Identifier: NCT03245060     History of Changes
Other Study ID Numbers: Staff/17-18/04
TSA Postdoc 2016/01 ( Other Grant/Funding Number: The Stroke Association )
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by City, University of London:
psychosocial well-being
solution focused brief therapy

Additional relevant MeSH terms:
Stroke
Aphasia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Pharmaceutical Solutions