Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000282684
Ethics application status
Approved
Date submitted
24/02/2014
Date registered
18/03/2014
Date last updated
18/08/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Moving 4 Mood: a trial of a physical activity intervention as an adjunct to regular care for young people with depression
Scientific title
A randomised controlled trial of a brief physical activity intervention in addition to standard clinical care for young people with depression
Secondary ID [1] 283443 0
Nil
Universal Trial Number (UTN)
U1111-1149-4278
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression (symptoms or disorder) in young people 290355 0
Condition category
Condition code
Mental Health 290750 290750 0 0
Depression
Public Health 291636 291636 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants who are randomised to the physical activity intervention will receive a manualised integrated physical activity intervention, based on a behavioural activation framework, in addition to routine clinical care (psychological therapy of the clinician’s choice).

The treatment manual/pack includes:
1) provision of resources (e.g., water bottle) and verbal and written information about the relationship between depressive symptoms and physical activity;
2) elicitation of the young person's ideas and beliefs about this information;
3) creating a list of costs and benefits for engaging in physical activity for mental health;
4) mapping current levels of physical activity;
5) provision of Australian Department of Health physical activity guidelines for their age group to assist with creating physical activity goals for the next 6-10 weeks;
6) brainstorming a range of physical activities (current and activities to try), separated into three levels based on energy expenditure (light, moderate, vigorous);
7) completing incremental goals for physical activity and recording sheet to monitor the relationship between mood and activity levels;
8) completing a weekly planner and discuss memory aides that could be used (e.g., physical activity mobile technology applications/'apps').


The intervention will be delivered in up to 10 weekly (or fortnightly) sessions, of 50 minutes duration, on an individual basis, by an allied health professional. The total duration of the intervention will be up to 10 weeks for weekly sessions (or up to 20 weeks for fortnightly sessions). Participants will receive weekly or fortnightly sessions depending on participant choice and availability and/or clinical judgement.

The fidelity of the physical activity intervention will be assessed by a brief allied health professional checklist following each session to measure the type of intervention and time spent delivering it in each session. Time spent on the intervention will contribute to the evaluation of its feasibility. The checklist will also assess the types and components of psychological therapies delivered as part of treatment as usual and an estimate of time spent on these.

Fidelity will also be assessed by audio-taping of a random selection of treatment sessions (approximately 25% of each allied health professional’s total session numbers). Twenty-five percent of the recordings will be coded by an independent rater for adherence to the treatment manual and to discriminate between the intervention and control conditions.

Fidelity of the intervention will also be assessed using a checklist of components of the active condition collected from participants at the endpoint assessment.

Intervention code [1] 288235 0
Treatment: Other
Intervention code [2] 288236 0
Rehabilitation
Intervention code [3] 288237 0
Behaviour
Comparator / control treatment
Participants who are randomised to the control group will receive psycho-education on physical activity in addition to routine clinical care (psychological therapy of clinician's choice).

Participants who are randomly allocated to this group will be provided with the same psycho-educational materials and resources as the intervention group, including the physical activity and mood monitoring sheets (see items 1 and 7 above). The importance of physical activity will be addressed in the first session but will not be included in ongoing treatment.

The intervention will be delivered in up to 10 weekly (or fortnightly) sessions, of 50 minutes duration, on an individual basis, by an allied health professional. The total duration of the intervention will be up to 10 weeks for weekly sessions (or up to 20 weeks for fortnightly sessions). Participants will receive weekly or fortnightly sessions depending on participant choice and availability and/or clinical judgement.

The fidelity of the psycho-education intervention will be assessed by a brief allied health professional checklist following each session to measure the type of intervention and time spent delivering it in each session.

Fidelity will also be assessed by audio-taping of a random selection of treatment sessions (approximately 25% of each allied health professional’s total session numbers). Twenty-five percent of the recordings will be coded by an independent rater for adherence to the treatment manual and to discriminate between the intervention and control conditions.

Fidelity of the intervention will also be assessed using a checklist of components of the control condition collected from participants at the endpoint assessment.
Control group
Active

Outcomes
Primary outcome [1] 290842 0
Self-report depression symptoms measured by the Quick Inventory of Depression Symptomatology (QIDS-SR)
Timepoint [1] 290842 0
Baseline (prior to receiving intervention)
Mid point (post completing two treatment sessions but prior to completing intervention)
End-point (post intervention)
Secondary outcome [1] 305453 0
Anxiety symptoms as measured by the Overall Anxiety Severity and Impairment Scale (OASIS)
Timepoint [1] 305453 0
Baseline (prior to receiving intervention)
End-point (post intervention)
Secondary outcome [2] 305454 0
Substance use as measured by the WHO Alcohol, Smoking and Substance Involvement screening test (ASSIST)
Timepoint [2] 305454 0
Baseline (prior to receiving intervention)
End-point (post intervention)
Secondary outcome [3] 305455 0
Suicidal ideation as measured by the Suicidal Ideation Questionnaire (SIQ).
Timepoint [3] 305455 0
Baseline (prior to receiving intervention)
End-point (post intervention)
Secondary outcome [4] 305457 0
Fitness levels as measured by the YMCA step test
Timepoint [4] 305457 0
Baseline (prior to receiving intervention)
End-point (post intervention)
Secondary outcome [5] 305458 0
Depression self-efficacy as measured by the Depression Coping Self-Efficacy Scale
Timepoint [5] 305458 0
Baseline (prior to receiving intervention)
End-point (post intervention)
Secondary outcome [6] 305459 0
Measurement of social support for exercise behaviours, measured by the Social Support and Exercise Survey
Timepoint [6] 305459 0
Baseline (prior to receiving intervention)
End-point (post intervention)
Secondary outcome [7] 305460 0
Physical activity self-efficacy as measured by the Exercise Confidence Survey
Timepoint [7] 305460 0
Baseline (prior to receiving intervention)
End-point (post intervention)
Secondary outcome [8] 305461 0
Therapeutic alliance measured by the Working Alliance Inventory
Timepoint [8] 305461 0
End-point (post intervention)
Secondary outcome [9] 305462 0
Treatment skills attained as measured by the Cognitive Behavioural Therapy Skills Questionnaire (CBTSQ)
Timepoint [9] 305462 0
Baseline (prior to receiving intervention)
End-point (post intervention)
Secondary outcome [10] 305463 0
General behavioural activation as measured by the Behavioural Activation for Depression Scale
Timepoint [10] 305463 0
Baseline (prior to receiving intervention)
End-point (post intervention)
Secondary outcome [11] 305464 0
Functioning measured by the Social And Occupational Functioning Assessment Scale (SOFAS)
Timepoint [11] 305464 0
Baseline (prior to receiving intervention)
End-point (post intervention)
Secondary outcome [12] 305465 0
Quality of life as measured by the Australian Quality of Life scale (AQoL 6d) for adolescents
Timepoint [12] 305465 0
Baseline (prior to receiving intervention)
End-point (post intervention)
Secondary outcome [13] 305466 0
Checklist of the helpfulness and use of skills associated with the active and control conditions
Timepoint [13] 305466 0
End-point (post intervention)
Secondary outcome [14] 305467 0
Knowledge, skills and attitudes of allied health professionals towards physical activity as an intervention for depression as measured by the Theoretical Domains Framework questionnaire
Timepoint [14] 305467 0
Baseline (prior to receiving training on intervention)
Study end (post completion of the project)
Secondary outcome [15] 306999 0
Self-report engagement in physical activity measured by the International Physical Activity Questionnaire (IPAQ)
Timepoint [15] 306999 0
Baseline (prior to receiving intervention)
End-point (post intervention)
Secondary outcome [16] 307000 0
Social support as measured by the Perceived Social Support Scale
Timepoint [16] 307000 0
Baseline (prior to receiving intervention)
End-point (post intervention)
Secondary outcome [17] 307001 0
Levels of physical activity as measured by a brief activity checklist
Timepoint [17] 307001 0
Baseline (prior to receiving intervention)
End-point (post intervention)

Eligibility
Key inclusion criteria
As this is a pragmatically oriented effectiveness trial, selection into the study will be based on ‘real-world’ characteristics of young people with depression: a) meeting the requirements for a Mental Health Treatment Plan (MHTP) to access psychological treatment under the Medicare Benefits Scheme Better Access program with likely diagnoses of major depressive disorder, rather than by a formal diagnostic research interview; OR b) endorsing items 7 to 10 (minimum of 3 out of the 4 items) on the Kessler Psychological Distress Scale(K10) with a score of 3 or more, indicating that depression symptoms have been experienced at least some of the time over the past 4 weeks. The K10 is part of the standardised intake assessment into headspace centres.
Minimum age
12 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion and withdrawal criteria: presence of psychotic symptoms during the intake assessment upon first presentation to the headspace centre; current physical activity meeting the Australian Government Guidelines (under 18 years: 60 mins/day moderate-vigorous activity; over 18 years: 30 mins moderate physical activity, most or all days); eating disorder symptoms reported at intake assessment, with the standardised assessment used when entering the service, conducted by Access Team clinicians; organic mental disorder; physical illness that contra-indicates participation in physical activity; intellectual disability/cognitive impairment that precludes providing informed consent.

Any young person reporting a prior history of physical illness will be required to receive medical clearance from a GP in order to partake in the trial.

Withdrawal from the study can be at the request of the participant or if any changes in the participant’s presentation warrants a referral to a specialist/tertiary service. Once withdrawn, the young person will be reviewed using the headspace centre’s standard clinical review procedure and either maintained in the headspace centre or referred to tertiary services as necessary. These young people will be withdrawn from treatment but will remain involved in the post-treatment assessment.

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)
All potentially eligible young people will be identified through the intake and assessment process of the mental health service. If a young person appears eligible and is interested in hearing more about the project, their details will be passed onto the the project’s research assistant (RA). The RA will formally assess eligibility and obtain informed consent from the young person (and, if required, from their parents and/or guardian). The RA will inform the allied health professionals if their client has consented to participate prior to their first treatment session. The allied health professional will be informed of the participant’s treatment group by an independent researcher who will access the outcome of the independently-prepared randomisation schedule. The RA will therefore remain blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation schedule will be devised by an independent statistician. Allocation to treatment will be concealed as it will be carried out by a researcher not involved in the day-to-day conduct of the trial, in accordance with International Conference on Harmonisation (ICH) Guideline E9. Participants will be randomised to either the active or control condition. A stratified randomisation design will be used to incorporate the characteristics of age (2 level factor: 12-17 yrs; and 18-25 yrs), sex (2 level factor) and symptom severity at baseline (2 level factor: QIDS cut-off points; <15 mild/moderate or >16 severe) since any chance imbalances on these variables may bias the analysis. Participants will be allocated to the treatment groups using randomly permuted blocks within each stratum, to ensure that subject allocation to the treatment groups is approximately equal.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses of continuous measures will be undertaken on an intent-to-treat basis, including all participants randomised regardless of treatment actually received or withdrawal from the study. Mixed-model repeated measures (MMRM) analyses will be used because of the ability of this approach to include participants with missing data without using discredited techniques such as last observation carried forward. The primary aim will be examined by a contrast evaluating change in depression symptoms from baseline to therapy end-point in the physical activity arm compared to that in the control condition.

The role of the physical activity measures as mediators of depressive symptom outcome will be explored in structural equation models implemented in Mplus. These analyses are important as they can demonstrate that changes in depression are associated with the component of the intervention theorized to be ‘active’. The impact of the psychological and skill attainment variables on depression outcomes will be examined using regression analyses to explore the impact of the intervention on variables thought to be associated with depression. Potential participant and therapist moderators of outcome such as gender, age and baseline severity of symptoms will be explored in secondary analyses.

Client numbers and profiles at comparable settings suggest that at least 120 participants could be recruited over 18 months. Allowing for withdrawal or loss to follow-up of 20% would result in 48 participants per arm and enable detection of effects down to of 0.56 standard deviations difference in means with 80% power. These calculations conservatively assume a 0.5 correlation between baseline and endpoint scores, a=0.05, two-tailed tests. In clinical terms, this corresponds to medium sized effect. For the QIDS, the inclusion of a mid-intervention assessment is likely to increase the power of the trial.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2013
Actual
1/10/2013
Date of last participant enrolment
Anticipated
28/11/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 7545 0
3067 - Abbotsford

Funding & Sponsors
Funding source category [1] 288232 0
Charities/Societies/Foundations
Name [1] 288232 0
headspace, the National Youth Mental Health Foundation
Country [1] 288232 0
Australia
Primary sponsor type
University
Name
Orygen Youth Health Research Centre, The University of Melbourne
Address
Locked Bag 10
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 287481 0
University
Name [1] 287481 0
University of Melbourne
Address [1] 287481 0
Parkville Campus, 1-100 Grattan st, Parkville VIC 3010
Country [1] 287481 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290137 0
Behavioural and Social Sciences Human Ethics Sub-Committee University of Melbourne
Ethics committee address [1] 290137 0
Ethics committee country [1] 290137 0
Australia
Date submitted for ethics approval [1] 290137 0
Approval date [1] 290137 0
20/08/2013
Ethics approval number [1] 290137 0
1340040.1

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

Contacts
Principal investigator
Name 43798 0
Dr Alexandra Parker
Address 43798 0
Orygen Youth Health Research Centre
Locked Bag 10 Parkville Vic 3052
Country 43798 0
Australia
Phone 43798 0
+61390270142
Fax 43798 0
+61390270199
Email 43798 0
[email protected]
Contact person for public queries
Name 43799 0
Susie Hansen
Address 43799 0
headspace Collingwood, Level 1, Victoria Park Social Club, Cnr Lulie & Abbott Streets, Collingwood, Victoria, 3067
Country 43799 0
Australia
Phone 43799 0
+61394170150
Fax 43799 0
+61 39416 3279
Email 43799 0
[email protected]
Contact person for scientific queries
Name 43800 0
Alexandra Parker
Address 43800 0
Orygen Youth Health Research Centre
Locked Bag 10 Parkville Vic 3052
Country 43800 0
Australia
Phone 43800 0
+61390270142
Fax 43800 0
+61390270199
Email 43800 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
No additional documents have been identified.