Condition category
Mental and Behavioural Disorders
Date applied
31/07/2009
Date assigned
19/11/2009
Last edited
07/02/2013
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

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 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

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

Trial setting

Other

Trial 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/02/2008

Overall trial end date

01/10/2009

Reason abandoned

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

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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
United Kingdom

Sponsor type

University/education

Website

http://www.manchester.ac.uk/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20430241

Publication citations

  1. Results

    Bee PE, Bower P, Gilbody S, Lovell K, Improving health and productivity of depressed workers: a pilot randomized controlled trial of telephone cognitive behavioral therapy delivery in workplace settings., Gen Hosp Psychiatry, 32, 3, 337-340, doi: 10.1016/j.genhosppsych.2010.01.006.

Additional files

Editorial Notes