Psychological treatment for depression in aphasic stroke patients: a randomised controlled trial

ISRCTN	ISRCTN63855912
DOI	https://doi.org/10.1186/ISRCTN63855912
Secondary identifying numbers	N0192165295

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 25/01/2019

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Shirley Thomas
Scientific

Research Associate
Division of Rehabilitation and Ageing
B Floor Medical School
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom

Phone	+44 (0)115 846 7484
Email	shirley.thomas@nottingham.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Psychological treatment for depression in aphasic stroke patients: a randomised controlled trial
Study objectives	To evaluate the effectiveness of behavioural treatments for low mood following stroke in people who have communication problems.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Mental and Behavioural Disorders: Depression
Intervention	This study uses a randomised controlled trial design (RCT). In this RCT aphasic patients with low mood will be randomly allocated to one of three groups: behavioural psychotherapy, attention placebo, no intervention. The attention placebo group is required to evaluate whether any improvement in mood in the behavioural treatment group is due to the content of the therapy or the fact that patients are receiving attention and interacting with someone regularly. The no intervention group is required to examine any spontaneous recovery in mood that occurs without any additional intervention. Patients in behavioural therapy group will receive up to 20 one hour sessions of therapy. Therapy duration is at discretion of therapist. Patients in attention placebo group will receive a comparable number of visits from psychologist. Patients in control group receive no contact with psychologist. Intervention will be administered by psychologist trained with stroke patients.
Intervention type	Other
Primary outcome measure	The primary outcome measures will be completed at 3 months and 6 months after randomisation to assess mood: Visual Analogue Mood Scales (VAMS) and Stroke Aphasic Depression Questionnaire (SADQ).
Secondary outcome measures	The secondary outcome measures will be completed at 3 months and 6 months after randomisation to assess any change in activity level: Extended Activities of Daily Living Scale (EADL) and Nottingham Leisure Questionnaire.
Overall study start date	01/04/2005
Completion date	01/12/2007
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	180
Key inclusion criteria	It is intended that 180 patients will be recruited, one-third (60) of these will be randomly allocated to a control group (no intervention group). Stroke patients with aphasia will be eligible for inclusion in the study. They will have been referred to the Speech & Language Therapists (SALT) in Nottingham with aphasia.
Key exclusion criteria	1. Patients will be excluded form the study if they are blind or deaf as it will not be practical to administer the assessments using standardised methods with these patients. These patients are still important, but a future study would be required to determine how assessments and therapies could be adapted for patients with severe vision and hearing problems. 2. Patients with dementia documented in their medical notes will be excluded as these patients may not have a reliable insight into their mood and the difficulties they face following their stroke. 3. Patients who received treatment for depression in the 5 years prior to their stroke will also be excluded as this study is concerned with patients who become depressed after their stroke. 4. Patients who live more than 40 miles from the recruiting centre will be excluded as it will not be practical for the researchers and therapist to visit these patients.
Date of first enrolment	01/04/2005
Date of final enrolment	01/12/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Queens Medical Centre

Division of Rehabilitation and Ageing
B Floor Medical School
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Queen's Medical Centre University Hospital NHS Trust

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

25/01/2019: The overall trial status has been changed to 'stopped'.
26/10/2016: No publications found, verifying study status with principal investigator