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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: ISRCTN
Last refreshed on: 17 October 2016
Main ID:  ISRCTN74390532
Date of registration: 26/03/2013
Prospective Registration: Yes
Primary sponsor: University of Exeter (UK)
Public title: Integrating Behavioural Activation and Physical Activity promotion (BAcPAc)
Scientific title: Integrating Behavioural Activation and Physical Activity promotion (BAcPAc): A pilot randomised controlled trial with depressed patients
Date of first enrolment: 01/04/2013
Target sample size: 80
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN74390532
Study type:  Interventional
Study design:  Pilot randomised controlled trial, Design type: Treatment (Treatment)  
Phase: 
Countries of recruitment
United Kingdom
Contacts
Name: Paul    Farrand
Address:  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: -
Email: P.A.Farrand@exeter.ac.uk
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Topic: Mental Health Research Network; Subtopic: Depression; Disease: Depression
Mental and Behavioural Disorders
Depressive episode
Intervention(s)
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)
Primary Outcome(s)
Depression PHQ9; Timepoint(s): baseline, 4 months, 9 months, 12 months
Secondary Outcome(s)
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
Secondary ID(s)
13288
Source(s) of Monetary Support
Medical Research Council (MRC) (UK) Grant Codes: MR/J000337/1
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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