Condition category
Mental and Behavioural Disorders
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
24/08/2012
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

Prof Mike Lucock

ORCID ID

Contact details

Adult Psychological Therapies Services
Fieldhead Hospital
Ouchthorpe Lane
Wakefield
WF1 3SP
United Kingdom

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 measures

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

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

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

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21810108

Publication citations

  1. 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.

Additional files

Editorial Notes