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

NCT03245060 | Completed

• 2 other identifiers: Staff/17-18/04TSA Postdoc 2016/01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphasia; Stroke

Keywords

psychosocial well-being; solution focused brief therapy

Outcome Measures

Primary Outcomes (1)

• Warwick Edinburgh Mental Well-being Scale (WEMWBS)

  Measures mental well-being. 14 items, scores range from 14 to 70, with higher scores indicating greater overall mental well-being

  6 months post randomization

Secondary Outcomes (4)

• Warwick Edinburgh Mental Well-being Scale (WEMWBS) - measuring change

  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).

• General Health Questionnaire-12 (GHQ-12) - measuring change

  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).

• Communicative Participation Item Bank (CPIB) - measuring change

  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).

• Depression Intensity Scale Circles (DISCS) - measuring change

  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).

Other Outcomes (1)

• European Quality of Life - 5 dimensions, 5 levels (EQ-5D-5L) - measuring change

  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).

Study Arms (2)

Intervention: immediate SFBT

EXPERIMENTAL

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

Intervention: delayed SFBT

OTHER

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

Interventions

Adapted Solution Focused Brief Therapy BEHAVIORAL

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; Intervention: immediate SFBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a diagnosis of ischaemic or haemorrhagic stroke
• At least six months post stroke
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• City, University of London: lead

Study Sites (1)

City, University of London

London, EC1V 0HB, United Kingdom

Location

Related Publications (2)

• Northcott S, Thomas S, James K, Simpson A, Hirani S, Barnard R, Hilari K. Solution Focused Brief Therapy in Post-Stroke Aphasia (SOFIA): feasibility and acceptability results of a feasibility randomised wait-list controlled trial. BMJ Open. 2021 Aug 18;11(8):e050308. doi: 10.1136/bmjopen-2021-050308.

  PMID: 34408055 DERIVED

• Northcott S, Simpson A, Thomas S, Barnard R, Burns K, Hirani SP, Hilari K. "Now I Am Myself": Exploring How People With Poststroke Aphasia Experienced Solution-Focused Brief Therapy Within the SOFIA Trial. Qual Health Res. 2021 Sep;31(11):2041-2055. doi: 10.1177/10497323211020290. Epub 2021 Jun 15.

  PMID: 34130554 DERIVED

MeSH Terms

Conditions

Aphasia; Stroke

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sarah Northcott, PhD

  City, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 10, 2017
• Study Start: October 17, 2017
• Primary Completion: August 14, 2019
• Study Completion: August 14, 2019
• Last Updated: February 10, 2020

Record last verified: 2019-01

Locations

GB (1)