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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN44929984 |
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Date of registration:
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19/11/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Telephone-administered cognitive behavioural therapy (CBT) for working adults
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Scientific title:
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Improving health and productivity: an exploratory randomised controlled trial (RCT) of delivery in an occupational setting |
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Date of first enrolment:
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01/02/2008 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN44929984 |
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Study type:
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Interventional |
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Study design:
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Pilot single centre randomised controlled trial (Quality of life)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Penny
Bee |
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Address:
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School of Nursing, Midwifery & Social Work
Jean Macfarlane Building
Oxford Road
M13 9PL
Manchester
United Kingdom |
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Telephone:
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+44 (0)161 306 7652 |
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Email:
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penny.bee@manchester.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Mild/moderate mental health difficulties
Mental and Behavioural Disorders
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Intervention(s)
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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
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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University of Manchester (UK) - School of Nursing, Midwifery and Social Work
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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