Behavioural activation therapy for depression after stroke

Not Applicable

Completed

• Conditions: Post-stroke depression; Mental and Behavioural Disorders

• Registration Number: ISRCTN12715175
• Lead Sponsor: niversity of Nottingham (UK)

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31524133 (added 17/09/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-16
• Study Completion: 2016-10-31
• Last Update Posted: 14 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The primary outcome measures in this study relate to the feasibility of proceeding to a definitive trial, based on:<br> 1. Feasibility of recruitment to the main trial<br> 2. Acceptability of the research procedures and measures<br> 3. Appropriateness of the baseline and outcome measures for assessing impact<br> 4. Retention of participants at outcome<br> 5. Potential value of conducting the definitive trial, based upon value of information analysis<br>