Telephone-administered cognitive behavioural therapy (CBT) for working adults

ISRCTN	ISRCTN44929984
DOI	https://doi.org/10.1186/ISRCTN44929984
Protocol serial number	N/A
Sponsor	University of Manchester (UK)
Funder	University of Manchester (UK) - School of Nursing, Midwifery and Social Work

Submission date: 31/07/2009
Registration date: 19/11/2009
Last edited: 07/02/2013

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 Penny Bee
Scientific

School of Nursing, Midwifery & Social Work
Jean Macfarlane Building
Oxford Road
Manchester
M13 9PL
United Kingdom

Phone	+44 (0)161 306 7652
Email	penny.bee@manchester.ac.uk

Study information

Primary study design	Interventional
Study design	Pilot single centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Improving health and productivity: an exploratory randomised controlled trial (RCT) of delivery in an occupational setting
Study objectives	Telephone-based cognitive behavioural therapy is likely to represent a feasible and clincally effective service for working adults with mild/moderate mental health problems.
Ethics approval(s)	University of Manchester Research Ethics Committee approved in October 2007 (ref: 07/1012/NMSW)
Health condition(s) or problem(s) studied	Mild/moderate mental health difficulties
Intervention	1. Usual care with 6-month follow-up 2. Usual care plus 12 sessions of telephone T-CBT delivered by graduate mental health workers, with 6-month follow-up
Intervention type	Other
Primary outcome measure(s)	Mental health symptom severity quantified by the 34-item Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM) at baseline, 3 months and 6 months follow-up.
Key secondary outcome measure(s)	1. Presence of anxiety and depressive-related symptoms quantified by the 14-item Hospital Anxiety and Depression Scale (HADS) 2. Self-rated functioning quantified by the Work and Social Adjustment Scale (WSAS) 3. Self-rated work productivity measured by the World Health Organization (WHO) Health and Work Performance Questionnaire Measured at baseline, 3 months and 6 months follow-up.
Completion date	01/10/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	60
Key inclusion criteria	1. Working adults aged 18 years and greater, either sex 2. Employed by a large UK communications company 3. Registered as absent from work due to mild/moderate mental health difficulties 4. Currently on sick leave of between 8 and 90 days as authorised by GP certificate
Key exclusion criteria	1. Severe or complex mental health problems (i.e. psychosis, post-traumatic stress disorder [PTSD], co-morbid personality disorder) 2. Degenerative cognitive disorders 3. Substance misuse 4. Active suicidal ideation or self-harm
Date of first enrolment	01/02/2008
Date of final enrolment	01/10/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

School of Nursing, Midwifery & Social Work

Manchester
M13 9PL
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	01/05/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes