Condition category
Mental and Behavioural Disorders
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
26/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Shirley Thomas

ORCID ID

Contact details

Research Associate
Division of Rehabilitation and Ageing
B Floor Medical School
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 846 7484
shirley.thomas@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0192165295

Study information

Scientific title

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

Acronym

Study hypothesis

To evaluate the effectiveness of behavioural treatments for low mood following stroke in people who have communication problems.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/04/2005

Overall trial end date

01/12/2007

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

180

Participant 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.

Recruitment start date

01/04/2005

Recruitment end date

01/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Queen's Medical Centre University Hospital NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/10/2016: No publications found, verifying study status with principal investigator