ISRCTN12715175Completed未知
BEhavioural Activation therapy for Depression after Stroke: a parallel group feasibility multicentre randomised controlled trial with nested qualitative research and economic evaluation, comparing behavioural activation to usual stroke care for patients with post-stroke depression.
niversity of Nottingham (UK)0 sites48 target enrollmentStarted: December 16, 2014Last updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 48
Study Overview
Brief Summary
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31524133 (added 17/09/2019)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •The criteria are designed to identify those who would be suitable for the intervention were it to be offered within clinical practice. Participants will be included in the study if they:
- •1. Have a diagnosis of ischaemic or haemorrhagic stroke
- •2. Are age 18 years or over
- •3. Are living in community settings, including home or nursing home
- •4. Are a minimum of three months and a maximum of five years post-stroke
- •5. Are identified as depressed, defined as:
- •5.1. For participants who are able to complete the Patient Health Questionnaire-9 (PHQ-9): a score of >10 on the PHQ-9
- •5.2. For participants with communication difficulties or severe cognitive difficulties who are
- •unable to complete the PHQ-9: a score of at least 50/100 on Visual Analog Mood Scales (VAMS) Sad item.
Exclusion Criteria
- •Current exclusion criteria as of 27/01/2016:
- •Participants will be excluded from the study if they:
- •1. Had a diagnosis of dementia prior to the stroke (based on self-report by patient/carer)
- •2. Were receiving medical or psychological treatment for depression at the time at which they had their stroke (based on self-report by patient/carer)
- •3. Are currently receiving psychological intervention
- •4. Have communication difficulties that would impact on their capacity to take part in the intervention (based on assessment with the Consent Support Tool [42] for people with aphasia)
- •5. Have visual or hearing impairments that would impact on their capacity to take part in the intervention (based on the therapist’s discretion at baseline assessment)
- •6. Were unable to communicate in English prior to the stroke
- •7. Do not have mental capacity to consent to take part in the trial.
- •Previous exclusion criteria:
- •Participants will be excluded from the study if they:
- •1. Had a diagnosis of dementia prior to the stroke (based on self-report by patient/carer)
- •2. Were receiving medical or psychological treatment for depression at the time at which they had their stroke (based on self-report by patient/carer)
- •3. Have communication difficulties that would impact on their capacity to take part in the intervention (based on assessment with the Consent Support Tool for people with aphasia)
- •4. Have visual or hearing impairments that would impact on their capacity to take part in the intervention (based on the therapist’s discretion at baseline assessment)
- •5. Were unable to communicate in English prior to the stroke
- •6. Do not have mental capacity to consent to take part in the trial
Investigators
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