Post-stroke depression Mental and Behavioural Disorders
Conditions
Interventions
Participants will be randomised to either Behavioural Activation Therapy or usual care.
Behavioural activation - This is a structured and individualised treatment which aims to increa
Sponsors
University of Nottingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures in this study relate to the feasibility of proceeding to a definitive trial, based on: 1. Feasibility of recruitment to the main trial 2. Acceptability of the research procedures and measures 3. Appropriateness of the baseline and outcome measures for assessing impact 4. Retention of participants at outcome 5. Potential value of conducting the definitive trial, based upon value of information analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to determine the feasibility of the delivery of the behavioural activation therapy intervention with people with post-stroke depression, based on: 1. Acceptability of behavioural activation therapy to participants, carers and therapists 2. Feasibility of delivering the intervention by Assistant Psychologists or IAPT therapist under supervision of an experienced mental health practitioner 3. Documentation of ‘usual care’ using healthcare resource use questionnaire 4. Treatment fidelity of the behavioural activation therapy 5. Feasibility of delivery of behavioural activation therapy within current services and within a definitive trial A series of other measures will be taken at 6 months to measure impact on patients' mood, health, quality of life and use of services; and carer strain, quality of life and support provided to the patient. The primary clinical outcome measure is PHQ-9. For those participants with moderate to severe language problems who are unable to complete the PHQ-9, the Visual Analog Mood Scales (VAMS) Sad item will be used | — |
Countries
United Kingdom
Outcome results
None listed