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Trial registered on ANZCTR

Registration number

ACTRN12614000772640

Ethics application status

Approved

Date submitted

9/07/2014

Date registered

21/07/2014

Date last updated

26/11/2019

Date data sharing statement initially provided

26/11/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

IMPACT Youth Study - Physical activity for young people with depression: A cluster randomised controlled trial to test the effectiveness of incorporating a brief intervention into routine clinical care.

Scientific title

Physical activity for young people with depression: A cluster randomised controlled trial to test the effectiveness of incorporating a brief physical activity intervention into routine clinical care compared to treatment as usual in reducing depressive symptoms.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

IMPACT Youth Study (Improving Mood with Physical ACTivity)

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Depression

Condition category

Condition code

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will receive either a physical activity intervention, based on a behavioural activation framework, in addition to routine clinical care (psychological therapy of the clinician’s choice), or psycho-education on physical activity and routine clinical care. The interventions will be integrated into routine clinical care at headspace centres and delivered by an allied health professional. The intervention will be delivered in an average of 4 treatment sessions (each session is usually 50 minutes in duration) across approximately 4-6 weeks. The intervention will be capped at a maximum of 10 sessions.

Physical activity intervention:
Participants will receive a manualised integrated physical activity intervention, embedded within routine clinical care. It will include the provision of resources and verbal and written information about the relationship between depressive symptoms and exercise; access to online resources providing advice on physical activities; and elicitation of the young person’s ideas and beliefs about this information. Clinicians randomised to this intervention will also work with the young person in creating a list of benefits and costs about physical activity and mental health to determine the young person’s readiness to change behaviour and identify motives to exercise and to increase the likelihood of exercising and maintaining changes in activity levels. Completing a weekly planner and discussing how and when the physical activity can be completed (no physical activity will be completed during sessions), and any memory aides that could be used to aid in completion of this (may include mobile technology applications (‘apps’)) will also form part of the intervention.
Clinicians will work with the young person to tailor the physical activity plan each week to suit the individual’s preferences and circumstances. An electronic accelerometer device will be used to obtain objective evidence of the young person's activity levels for one week following baseline and then again for one week at the end of the intervention period.

Intervention code [1]

Behaviour

Comparator / control treatment

Psycho-education intervention:
Participants who receive treatment from a clinician who has been allocated to this group will be provided with the same written psycho-educational materials and resources as the intervention group. The importance of physical activity will be addressed in the first session but will not be included in ongoing treatment.
An electronic accelerometer device will be used to obtain objective evidence of the young person's activity levels for one week following baseline and then again for one week at the end of the intervention period.

Control group

Active

Outcomes

Primary outcome [1]

Level of depression symptoms at post-treatment measured by the 17-item clinician-rated Quick Inventory of Depression Symptoms - Adolescent Version (QIDS-A17-C).

Timepoint [1]

Change in QIDS-A17-C scores, between baseline and end of study intervention (between 4-10 sessions).

Secondary outcome [1]

Level of depression symptoms at 6 months post-treatment measured by the 17-item clinician-rated Quick Inventory of Depression Symptoms - Adolescent Version (QIDS-A17-C).

Timepoint [1]

Change in QIDS-A17-C scores between baseline and 6 months post-treatment.

Secondary outcome [2]

Change in symptom measures, between baseline and post-treatment via the Clinician-rated depression symptoms as measured by the Montgomery Asberg Depression Rating Scale.

Timepoint [2]

Changes between baseline and post-intervention (between 4-10 sessions, at the end of the intervention).

Secondary outcome [3]

Change in process measures, between baseline and post-treatment via: Physical: a) Levels of physical activity measured by the International Physical Activity Questionnaire; b) Levels of physical activity measured by an electronic accelerometer device worn for 5-7 days (physical activity intervention group and psycho-education/control group); c) checklist of physical activities undertaken each week; d) Pittsburg Sleep Quality Index; e) height, weight and hip and waist measurements; and f) the Simple Dietary Questionnaire (SDQ).

Timepoint [3]

Changes between baseline and post-intervention (between 4-10 sessions, at the end of the intervention).

Secondary outcome [4]

Change in clinicians knowledge, skills and attitudes towards physical activity measured by the Theoretical Domains Framework questionnaire, pre-training on the intervention and after commencement of conducting the intervention.

Timepoint [4]

Changes between pre-training on the study intervention and after commencement of conducting the intervention.

Secondary outcome [5]

Change in symptom measures, between baseline and post-treatment via the Depression module from the SCID-IV to confirm diagnosis of depression.

Timepoint [5]

Changes between baseline and post-intervention (between 4-10 sessions, at the end of the intervention).

Secondary outcome [6]

Change in symptom measures, between baseline and post-treatment via the Anxiety symptoms measured by the Overall Anxiety Severity and Impairment Scale.

Timepoint [6]

Changes between baseline and post-intervention (between 4-10 sessions, at the end of the intervention).

Secondary outcome [7]

Change in symptom measures, between baseline and post-treatment via the Substance use measured by the WHO Alcohol, Smoking and Substance Involvement screening test.

Timepoint [7]

Changes between baseline and post-intervention (between 4-10 sessions, at the end of the intervention).

Secondary outcome [8]

Change in psychological domains, between baseline and post-treatment via: a) General Self Efficacy Scale; b) Barriers Self-Efficacy Scale; c) Perceived Social Support Scale; d) Positive and Negative Affect Schedule; and e) Therapeutic alliance measured by the Working Alliance Inventory (post-intervention only).

Timepoint [8]

Changes between baseline and post-intervention (between 4-10 sessions, at the end of the intervention).

Secondary outcome [9]

Change in Skill attainment, between baseline and post-treatment via: a) Cognitive and Behavioural Therapy Skills Questionnaire; and b) the Behavioural Activation for Depression Scale.

Timepoint [9]

Changes between baseline and post-intervention (between 4-10 sessions, at the end of the intervention).

Secondary outcome [10]

Change in functioning measures, between baseline and post-treatment via: a) Social and Occupational Functional Assessment Scale; and b) Australian Quality of Life scale for adolescents.

Timepoint [10]

Changes between baseline and post-intervention (between 4-10 sessions, at the end of the intervention).

Eligibility

Key inclusion criteria

As this is a pragmatic 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 or Access to Allied Psychological Services (ATAPS) with likely diagnoses of major depressive disorder, rather than by a formal diagnostic research interview; and b) a score on the clinician-rated Quick Inventory of Depression Symptoms - Adolescent Version of 11 or greater, indicating depression levels of moderate or above.

Minimum age

12 Years

Maximum age

25 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Presence of a psychotic disorder meeting diagnostic threshold 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); presence of an eating disorder meeting diagnostic threshold assessed during the standard intake procedure at headspace centres, using a standardised psychosocial assessment; 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 which might impede their ability to take part in physical activity will be required to receive medical clearance from a GP in order to partake in the trial.

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)

Participants will be assessed for eligibility by a research assistant. Clinicians will be randomly allocated to the intervention and control groups. A stratified randomisation design will be used to incorporate characteristics of; sex of clinician (2 level factor, male/female), background training of clinician (2 level factor, psychologist/non-psychologist) and headspace centre to ensure equal numbers of each intervention at each site. Participants (young people) will be assigned to a clinician based on a randomised list subject to clinician availability constraints. Participants will be stratified by age (less than or equal to 17, 18+), gender (male/female) and QIDS-A17-C score (less than or equal to 15, 16+).

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomisation schedule will be devised by an independent statistician and carried out through a centralised randomisation service, to ensure allocation concealment.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

19/01/2015

Actual

25/06/2015

Date of last participant enrolment

Anticipated

31/10/2018

Actual

1/05/2018

Date of last data collection

Anticipated

Actual

29/08/2019

Sample size

Target

960

Accrual to date

Final

472

Recruitment in Australia

Recruitment state(s)

NSW,QLD,SA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Other

Name

Orygen, The National Centre of Excellence in Youth Mental Health

Address

35 Poplar Road, Parkville, VIC 3052

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Melbourne Human Research Ethics Committee

Ethics committee address [1]

Office for Research Ethics and Integrity
Level 1, 780 Elizabeth Street
Melbourne VIC 3010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/05/2014

Approval date [1]

18/06/2014

Ethics approval number [1]

1442228

Summary

Brief summary

Depressive disorders are highly prevalent and are the leading cause of disability in young people worldwide. While there is an increasing evidence base regarding effective treatments for youth depression, interventions that are recommended by the Australian clinical practice guidelines, such as cognitive behavioural therapy (CBT), are only modestly effective in this age group. There is an urgent need for additional treatment strategies to treat current problems as well as prevent the onset of secondary or comorbid mental disorders and disability. One such strategy that has an emerging evidence-base is physical activity as an augmentation or adjunct treatment. Physical activity is a low-stigma intervention with few side effects, factors that are important to help-seeking young people. 

This project aims to evaluate the effectiveness of a brief physical activity intervention that is integrated into usual clinical care in reducing depression and increasing engagement in physical activity in help-seeking young people. All allied health professionals at selected headspace centres (enhanced primary care youth mental health services) will be invited to take part in the project and those who participate will be offered training in the delivery of the intervention and a treatment manual. All help-seeking young people aged 12-25 years who present to the selected headspace centres will be screened for eligibility to participate in a cluster randomised controlled trial (RCT). Clinicians will be randomised to be trained in and to deliver either the physical activity intervention (active condition) or the psychoeducation (control condition) in addition to routine clinical care. Young people who consent to take part will be allocated to receive treatment from a clinician who has been randomised to deliver either the physical activity intervention or psychoeducation on physical activity in addition to treatment as usual. 

The primary hypothesis is that the physical activity intervention will lead to greater reductions in depressive symptoms compared to treatment as usual. The secondary hypothesis is, a) that the physical activity intervention will lead to: i) reduction in anxiety symptoms; and ii) improvements in functioning, when compared to treatment as usual; b) that changes in depressive symptoms will be mediated by increased physical activity.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Alexandra Parker, MPsych(Clin), PhD

Address

Victoria University, PO Box 14428, Melbourne, Vic 8001, Australia

Country

Australia

Phone

+61 3 9919 5874

Fax

Alex.Parker@vu.edu.au

Contact person for public queries

Name

Connie Markulev, MPsych(Clin)

Address

Orygen, The National Centre of Excellence in Youth Mental Health. Locked Bag 10, Parkville, VIC 3052

Country

Australia

Phone

+61 3 9966 9571

Fax

conniem@unimelb.edu.au

Contact person for scientific queries

Name

Alexandra Parker, MPsych(Clin), PhD

Address

Victoria University, PO Box 14428, Melbourne, Vic 8001, Australia

Country

Australia

Phone

+61 3 9919 5874

Fax

Alex.Parker@vu.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All of the individual trial-related participant data collected during the trial, after de-identification.

When will data be available (start and end dates)?

Following main results publication, for three years.

Available to whom?

Investigators whose proposed use of the data has been approved by an independent review committee

Available for what types of analyses?

To achieve aims in the approved protocol

How or where can data be obtained?

Proposals can be submitted up to three years following article publication. Initial contact should be directed to an Executive Officer at Orygen, The National Centre of Excellence in Youth Mental Health main office located in Parkville Victoria. Phone +61 399669574 or via https://www.orygen.org.au/Contact/Contact-Us#ContactForm
Note: Data requestors will need to sign a data access agreement

What supporting documents are/will be available?

Doc. No.	Type	Link	Other Details
5875	Study protocol	https://www.orygen.org.au/Contact#ContactForm	Initial contact should be directed to an Executive... [More Details]
5876	Statistical analysis plan		Initial contact should be directed to an Executive... [More Details]
5877	Informed consent form		Initial contact should be directed to an Executive... [More Details]
5878	Ethical approval		Initial contact should be directed to an Executive... [More Details]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Improving Mood with Physical ACTivity (IMPACT) trial: A cluster randomised controlled trial to determine the effectiveness of a brief physical activity behaviour change intervention on depressive symptoms in young people, compared with psychoeducation, in addition to routine clinical care within youth mental health services-a protocol study.	2019	https://dx.doi.org/10.1136/bmjopen-2019-034002

N.B. These documents automatically identified may not have been verified by the study sponsor.

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