Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000638730
Ethics application status
Approved
Date submitted
31/05/2013
Date registered
6/06/2013
Date last updated
24/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Healthy Body Healthy Mind: Randomised controlled trial of an exercise intervention for the treatment of youth depression
Scientific title
A randomised controlled trial investigating an exercise intervention as a treatment for major depressive disorder as diagnosed by the Standardised Clinical Interview for Diagnostic and Statistical Manual IV (SCID) in young people aged 15-25 years.
Secondary ID [1] 282440 0
nil
Universal Trial Number (UTN)
Trial acronym
HBHM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder in young people aged 15-25 289047 0
Condition category
Condition code
Mental Health 289387 289387 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 week multi-modal exercise program incorporating motivational interviewing, resistance training and aerobic training. Three 1 hour exercise sessions per week for 12 weeks. The program is progressive in nature, starting at a low to moderate intensity.
Intervention code [1] 287082 0
Behaviour
Intervention code [2] 287293 0
Lifestyle
Comparator / control treatment
Wait list control (12 weeks)
Control group
Active

Outcomes
Primary outcome [1] 289495 0
Diagnosis of Major Depressive Disorder as per SCID (standardised clinical interview for DSM-IV disorders)
Timepoint [1] 289495 0
12 and 24 weeks after randomisation
Primary outcome [2] 289713 0
Beck depression score
Timepoint [2] 289713 0
12 and 24 weeks after randomisation
Secondary outcome [1] 303073 0
Beck Anxiety Inventory
Timepoint [1] 303073 0
12 and 24 weeks after randomisation
Secondary outcome [2] 303074 0
Aerobic fitness as assessed by indirect calorimetry
Timepoint [2] 303074 0
12 weeks and 24 weeks after randomisation
Secondary outcome [3] 303075 0
YMCA Bench press test
Timepoint [3] 303075 0
12 weeks and 24 weeks after randomisation
Secondary outcome [4] 303076 0
Quality of Life Enjoyment and Satisfaction Questionnaire - Short From
Timepoint [4] 303076 0
12 and 24 weeks after randomisation
Secondary outcome [5] 303077 0
Satisfaction with Life Scale
Timepoint [5] 303077 0
12 and 24 weeks after randomisation
Secondary outcome [6] 303078 0
Physical Health Questionnaire (PHQ-15)
Timepoint [6] 303078 0
12 and 24 weeks after randomisation
Secondary outcome [7] 303079 0
Self efficacy- assessed by exercise self efficacy questionnaire
Timepoint [7] 303079 0
12 and 24 weeks after randomisation
Secondary outcome [8] 303080 0
Depression and Somatic Scale (DSSS)
Timepoint [8] 303080 0
12 and 24 weeks after randomisation
Secondary outcome [9] 303081 0
Automatic Thoughts Questionnaire
Timepoint [9] 303081 0
12 and 24 weeks after randomisation
Secondary outcome [10] 303082 0
Dysfunctional Attitudes Scale
Timepoint [10] 303082 0
12 and 24 weeks after randomisation
Secondary outcome [11] 303083 0
Behavioural Activation for Depression Scale (BADS)
Timepoint [11] 303083 0
12 and 24 weeks after randomisation
Secondary outcome [12] 303084 0
Beck Depression Inventory
Timepoint [12] 303084 0
6 weeks after randomistation
Secondary outcome [13] 303085 0
Goal evaluation and resolve, assessed by confidence to exercise questionnaire
Timepoint [13] 303085 0
4, 8, 12 and 24 weeks after randomisation

Eligibility
Key inclusion criteria
Aged 15-25 years, current diagnosis of major depressive disorder, routine access to the internet
Minimum age
15 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other psychiatric illnesses (e.g. schizophrenia, bipolar disorder) or acquired brain injury, health condition or physical injury that would interfere with capacity to exercise, inability to stay in geographical area for length of intervention, pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/06/2013
Actual
11/06/2013
Date of last participant enrolment
Anticipated
Actual
15/10/2015
Date of last data collection
Anticipated
Actual
19/05/2016
Sample size
Target
50
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 6816 0
2308 - Newcastle University
Recruitment postcode(s) [2] 6817 0
2300 - Newcastle

Funding & Sponsors
Funding source category [1] 287215 0
Charities/Societies/Foundations
Name [1] 287215 0
Hunter Medical Research Institute
Country [1] 287215 0
Australia
Funding source category [2] 287216 0
Charities/Societies/Foundations
Name [2] 287216 0
beyondblue
Country [2] 287216 0
Australia
Primary sponsor type
Individual
Name
Prof Robin Callister
Address
ATC Level 3, University Drive, Callaghan, NSW 2308
Country
Australia
Secondary sponsor category [1] 285971 0
None
Name [1] 285971 0
Address [1] 285971 0
Country [1] 285971 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289204 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 289204 0
Ethics committee country [1] 289204 0
Australia
Date submitted for ethics approval [1] 289204 0
Approval date [1] 289204 0
29/04/2013
Ethics approval number [1] 289204 0
H-2012-0114
Ethics committee name [2] 298470 0
Hunter New England Human Research Ethics Committee (HNEHREC)
Ethics committee address [2] 298470 0
Ethics committee country [2] 298470 0
Australia
Date submitted for ethics approval [2] 298470 0
Approval date [2] 298470 0
26/05/2015
Ethics approval number [2] 298470 0
15/04/15/4.05

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39770 0
Prof Robin Callister
Address 39770 0
University of Newcastle, Level 3 ATC Building, University Drive, Callaghan, NSW 2308
Country 39770 0
Australia
Phone 39770 0
+61 2 49215650
Fax 39770 0
Email 39770 0
[email protected]
Contact person for public queries
Name 39771 0
Adriana Giles
Address 39771 0
University of Newcastle, Level 3 ATC Building, University Drive, Callaghan, NSW 2308
Country 39771 0
Australia
Phone 39771 0
+61 2 49216311
Fax 39771 0
Email 39771 0
[email protected]
Contact person for scientific queries
Name 39772 0
Robin Callister
Address 39772 0
University of Newcastle, Level 3 ATC Building, University Drive, Callaghan, NSW 2308
Country 39772 0
Australia
Phone 39772 0
+61 2 49215650
Fax 39772 0
Email 39772 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluating the efficacy of an integrated motivational interviewing and multi-modal exercise intervention for youth with major depression: Healthy Body, Healthy Mind randomised controlled trial protocol.2018https://dx.doi.org/10.1016/j.conctc.2017.11.007
EmbaseDifferential treatment effects of an integrated motivational interviewing and exercise intervention on depressive symptom profiles and associated factors: A randomised controlled cross-over trial among youth with major depression.2019https://dx.doi.org/10.1016/j.jad.2019.08.035
EmbaseEngaging youth with major depression in an exercise intervention with motivational interviewing.2019https://dx.doi.org/10.1016/j.mhpa.2019.100295
N.B. These documents automatically identified may not have been verified by the study sponsor.