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. |
Register:
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ISRCTN |
Last refreshed on:
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17 October 2016 |
Main ID: |
ISRCTN74390532 |
Date of registration:
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26/03/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Integrating Behavioural Activation and Physical Activity promotion (BAcPAc)
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Scientific title:
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Integrating Behavioural Activation and Physical Activity promotion (BAcPAc): A pilot randomised controlled trial with depressed patients |
Date of first enrolment:
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01/04/2013 |
Target sample size:
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80 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN74390532 |
Study type:
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Interventional |
Study design:
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Pilot randomised controlled trial, Design type: Treatment (Treatment)
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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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Paul
Farrand |
Address:
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Clinical Education, Development and Research (CEDAR)
School of Psychology
University of Exeter
Room 238
Washington Singer Laboratories
Perry Road
EX4 4QG
Exeter
United Kingdom |
Telephone:
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- |
Email:
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P.A.Farrand@exeter.ac.uk |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Male and female, aged 18 and over, upper age limit 90 years 2. Soring between 10-23 on the Participant Health Questionnaire (PHQ-9), (which indicates moderate to moderately severe depression) 3. With an episode of depression confirmed using the structured diagnostic Clinical Interview Schedule (CIS-R) 4. Participants will be asked to confirm if they are able to walk continuously for five minutes
Exclusion criteria: Current exclusion criteria as of 04/03/2014: 1. Diagnosis of severe and enduring mental health problem, 2. Currently or prior to current episode of depression, doing at least 30 minutes accumulated moderate/vigorous intensity physical activity on 5 or more days of the week, 3. Score of 2/3 on PHQ-9 suicide risk question 4. Alcohol problem 5. Drug addiction 6. Inability to use written self-help materials in English
Previous exclusion criteria: 1. Diagnosis of severe and enduring mental health problem, 2. Currently or prior to current episode of depression, doing at least 30 minutes accumulated moderate/vigorous intensity physical activity on 5 or more days of the week, 3. Score of 2/3 on PHQ-9 suicide risk question 4. Changed or newly prescribed antidepressant in previous month 5. Alcohol problem 6. Drug addiction 7. Inability to use written self-help materials in English
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Topic: Mental Health Research Network; Subtopic: Depression; Disease: Depression Mental and Behavioural Disorders Depressive episode
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Intervention(s)
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40 patients will be randomly allocated to Behavior Activation (normal care) and 40 will be randomly allocated to Behaviour Activation plus Physical Activity (BAcPAc).
BAcPAc, Adapted Behavioural Activation delivered by Psychological Wellbeing Practitioners with an new emphasis on increasing or adding sustainable physical activity into scheduled routine, necessary or pleasurable activities.
Follow Up Length: 12 month(s)
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Primary Outcome(s)
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Depression PHQ9; Timepoint(s): baseline, 4 months, 9 months, 12 months
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Secondary Outcome(s)
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1. Blood pressure; Timepoint(s): baseline, 4 months, 9 months 2. Body mass index (BMI) ; Timepoint(s): baseline, 4 months, 9 months 3. EQ5D; Timepoint(s): baseline, 4 months, 9 months 4. Health and social care service use; Timepoint(s): baseline, 4 months, 9 months 5. ISI; Timepoint(s): baseline, 4 months, 9months 6. SF-36; Timepoint(s): baseline, 4 months, 9 month
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Source(s) of Monetary Support
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Medical Research Council (MRC) (UK) Grant Codes: MR/J000337/1
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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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