Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0266184278
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM)
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/2006
Overall trial end date
01/09/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
205
Participant exclusion criteria
1. Patients with severe depression
2. Personality disorders
3. Severe substance misuse and psychosis
Recruitment start date
01/02/2006
Recruitment end date
01/09/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Adult Psychological Therapies Services
Wakefield
WF1 3SP
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 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
Funders
Funder type
Government
Funder name
South West Yorkshire Mental Health NHS Trust (UK), 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
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21810108
Publication citations
-
Results
Lucock M, Kirby R, Wainwright N, A pragmatic randomized controlled trial of a guided self-help intervention versus a waiting list control in a routine primary care mental health service., Br J Clin Psychol, 2011, 50, 3, 298-309, doi: 10.1348/014466510X520231.