RCT of self-help intervention - phase 2
| ISRCTN | ISRCTN27657750 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27657750 |
| Protocol serial number | N0266184278 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funder | South West Yorkshire Mental Health NHS Trust (UK), NHS R&D Support Funding |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 24/08/2012
- 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
Prof Mike Lucock
Scientific
Scientific
Adult Psychological Therapies Services
Fieldhead Hospital
Ouchthorpe Lane
Wakefield
WF1 3SP
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | Is there a difference in clinical outcomes between clients who receive a 1+ 1 model of facilitated self help intervention shortly after initial assessment compared to a waiting list control? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Mental and Behavioural Disorders: Anxiety disorders |
| Intervention | A randomised controlled trial of a self help intervention for anxiety patients waiting for psychological therapy phase 2. Quantitative & qualitative. Random allocation to: 1. Early facilitation group (EFG) 2. Delayed facilitation group (DFG) EFG offered session > 2 weeks following screening; DFG standard waiting list. |
| Intervention type | Other |
| Primary outcome measure(s) |
Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 205 |
| Key inclusion criteria | 1. 2 groups of service users within Primary Care and Liaison Treatment Team (PLATT) team 2. Patients screened by a primary care mental health team who have mild to moderate anxiety and depression problems |
| Key exclusion criteria | 1. Patients with severe depression 2. Personality disorders 3. Severe substance misuse and psychosis |
| Date of first enrolment | 01/02/2006 |
| Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Adult Psychological Therapies Services
Wakefield
WF1 3SP
United Kingdom
WF1 3SP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/09/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
