An exploratory randomised controlled trial of a DEPression Recognition and Treatment package for families living with STROKE

Not Applicable

Completed

• Conditions: Topic: Mental Health Research Network; Subtopic: Depression; Disease: Depression; Circulatory System; Stroke/depression

• Registration Number: ISRCTN32451749
• Lead Sponsor: orfolk and Norwich University Hospital NHS Trust (UK)

Brief Summary

2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21529370

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-04
• Study Completion: 2015-01-02
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

Current inclusion criteria as of 28/04/2014:
1. Patient diagnosed with ischaemic or haemorrhagic stroke
2. Stroke type confirmed
3. Patient identified by a participating NHS Trust
4. Patient diagnosed with a stroke between 1 month and 5 years ago.
5. Patient has been living at home for not less than 2 weeks
6. Patient has a self-defined ?primary carer?
7. Patient and/or carer scores as depressed on any clinical tool used to identify depression in clinical practice
8. Patient and carer over 18 years of age (no upper age limit)

Previous inclusion criteria:
1. Patient diagnosed with ischaemic or haemorrhagic stroke
2. Stroke type confirmed by computerised tomography scan
3. Patient listed in the NNUH Stroke Register
4. Patient diagnosed with a stroke for at least three months.
5. Patient has been living at home for not less than two weeks
6. Patient has a self defined ?primary carer?.
7. Patient and/or carer scores =8 on the Hospital Anxiety and Depression Scale (HADS)
8. Patient and carer aged between 18-110 years of age
We have stipulated the widest possible age range for eligibility as the DepReTStroke package will be designed to be as inclusive as possible and accommodate the needs of persons with stroke and their carers irrespective of age.

Target Gender: Male & Female; Upper Age Limit 110 years ; Lower Age Limit 18 years

Exclusion Criteria

1. Serious or unstable medical conditions (e.g. advanced/incurable cancer; severe comorbidity or severe unpredictable pain)
2. Psychosis or other severe mental illness
3. Suicidal thoughts or ideation
4. Dementia
5. Institutionalised (e.g. care home resident)
6. Participating in any other research concerning stroke or depression

Added 28/04/2014:
7. Current treatment for depression (anti-depressant medication or talking therapies)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mental Component Summary of the SF-36v2; Timepoint(s): Six months

Secondary Outcome Measures

Name	Time	Method
Beliefs about Medicines Questionniare (BMQ); Timepoint(s): 6 months; Hospital Anxiety and Depression Scale (HADS); Timepoint(s): 6 months; Knowledge of Depression Multiple Choice Question Test; Timepoint(s): 6 months