Condition category
Mental and Behavioural Disorders
Date applied
11/04/2005
Date assigned
16/05/2005
Last edited
14/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.npcrdc.man.ac.uk/ResearchDetail.cfm?ID=73

Contact information

Type

Scientific

Primary contact

Dr Peter Bower

ORCID ID

Contact details

National Primary Care Research and Development Centre (NPCRDC)
5th Floor
Williamson Building
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 275 7638
peter.bower@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

SHADE

Study hypothesis

Provision of guided self-help will produce superior clinical outcomes to waiting list management at 3-month follow-up for patients with anxiety and depression

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

Other

Trial type

Treatment

Patient information sheet

Condition

Anxiety/depression

Intervention

Intervention group - use of a written self-help manual and up to 4 brief (15-30 minute) face-to-face facilitation sessions with a graduate assistant psychologist while on waiting list.
Waiting list control group - patients remain on waiting list, with routine support (as required) from primary care provider.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The Hospital Anxiety and Depression Scale (HADS) score

Secondary outcome measures

1. Beck Depression Inventory (BDI)
2. Social Adjustment Scale (SAS)
3. Clinical Outcomes in Routine Evaluation scale (CORE)
4. Patient satisfaction and other self-report measures of the treatment process

Overall trial start date

01/01/2002

Overall trial end date

31/01/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients with anxiety/depression referred from primary care to one of three Greater Manchester psychological therapy services and currently with 3+ months remaining on the waiting list.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

114

Participant exclusion criteria

1. Under 18 years of age
2. Baseline score <14 on the Beck Depression Inventory (BDI) and <11 on anxiety scale of the Hospital Anxiety and Depression Scale (HADS)
3. Referred for therapy from source other than primary care
4. Less than 3 months remaining on therapy service waiting list
5. Poor proficiency in English (i.e. inability to complete questionnaires or read the self-help manual)
6. Active suicidal thoughts
7. Current substance misuse
8. Organic brain disease
9. Current contact with specialist mental health services

Recruitment start date

01/01/2002

Recruitment end date

31/01/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

National Primary Care Research and Development Centre (NPCRDC)
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

National Primary Care Research and Development Centre (NPCRDC) (UK)

Sponsor details

5th Floor
Williamson Building
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

National Primary Care Research and Development Centre (NPCRDC) (UK) - via core funding from the Department of Health

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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16219121

Publication citations

  1. Results

    Mead N, MacDonald W, Bower P, Lovell K, Richards D, Roberts C, Bucknall A, The clinical effectiveness of guided self-help versus waiting-list control in the management of anxiety and depression: a randomized controlled trial., Psychol Med, 2005, 35, 11, 1633-1643, doi: 10.1017/S003329170500560X.

Additional files

Editorial Notes