Telephone-administered cognitive behavioural therapy (CBT) for working adults
| ISRCTN | ISRCTN44929984 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44929984 |
| Secondary identifying numbers | N/A |
- 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
Scientific
School of Nursing, Midwifery & Social Work
Jean Macfarlane Building
Oxford Road
Manchester
M13 9PL
United Kingdom
| Phone | +44 (0)161 306 7652 |
|---|---|
| penny.bee@manchester.ac.uk |
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 |
| Completion date | 01/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
School of Nursing, Midwifery & Social Work
Manchester
M13 9PL
United Kingdom
M13 9PL
United Kingdom
Sponsor information
University of Manchester (UK)
University/education
University/education
Oxford Road
Manchester
M13 9PL
England
United Kingdom
| Website | http://www.manchester.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
University/education
University of Manchester (UK) - School of Nursing, Midwifery and Social Work
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
