A pragmatic randomised controlled trial to assess the clinical effectiveness of 'guided self-help' versus 'waiting list control' in the management of anxiety and depression in primary care. Self-Help in Anxiety and DEpression (SHADE).
| ISRCTN | ISRCTN33308608 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33308608 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/04/2005
- Registration date
- 16/05/2005
- Last edited
- 14/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Peter Bower
Scientific
Scientific
National Primary Care Research and Development Centre (NPCRDC)
5th Floor
Williamson Building
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
| Phone | +44 (0)161 275 7638 |
|---|---|
| peter.bower@manchester.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study acronym | SHADE |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2002 |
| Completion date | 31/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 114 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 31/01/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
National Primary Care Research and Development Centre (NPCRDC)
Manchester
M13 9PL
United Kingdom
M13 9PL
United Kingdom
Sponsor information
National Primary Care Research and Development Centre (NPCRDC) (UK)
University/education
University/education
5th Floor
Williamson Building
University of Manchester
Oxford Road
Manchester
M13 9PL
England
United Kingdom
Funders
Funder type
University/education
National Primary Care Research and Development Centre (NPCRDC) (UK) - via core funding from the Department of Health
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2005 | Yes | No |
