Contact information
Type
Scientific
Contact name
Dr Penny Bee
ORCID ID
Contact details
School of Nursing
Midwifery & Social Work
Jean Macfarlane Building
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 306 7652
penny.bee@manchester.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Improving health and productivity: an exploratory randomised controlled trial (RCT) of delivery in an occupational setting
Acronym
Study hypothesis
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)
Study design
Pilot single centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
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.
Secondary outcome measures
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.
Overall study start date
01/02/2008
Overall study end date
01/10/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
60
Participant 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
Recruitment start date
01/02/2008
Recruitment end date
01/10/2009
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
School of Nursing, Midwifery & Social Work
Manchester
M13 9PL
United Kingdom
Sponsor information
Organisation
University of Manchester (UK)
Sponsor details
Oxford Road
Manchester
M13 9PL
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
University/education
Funder name
University of Manchester (UK) - School of Nursing, Midwifery and Social Work
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2010 | Yes | No |