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Trial registered on ANZCTR


Registration number
ACTRN12608000550303
Ethics application status
Approved
Date submitted
15/09/2008
Date registered
30/10/2008
Date last updated
10/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The acceptability and effectiveness of simple interventions in reducing mental health problems in help-seeking young people
Scientific title
The acceptability and effectiveness of a combination of problem solving therapy and behavioural exercise intervention compared to a combination of supportive counselling and exercise psychoeducation in reducing depression and anxiety symptoms in help-seeking young people aged 12-25 years: A factorial randomised controlled trial
Secondary ID [1] 253234 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emerging, sub-threshold or early stages of anxiety disorders 3684 0
Emerging, sub-threshold or early stages of depressive disorders 3685 0
Condition category
Condition code
Mental Health 3849 3849 0 0
Depression
Mental Health 3850 3850 0 0
Anxiety
Mental Health 3851 3851 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Problem solving therapy (one session weekly for 6 weeks) and behavioural exercise intervention (one session weekly for 6 weeks). The duration of each session will be approximately 50 minutes (approx 35-40 mins problem solving and 10-15 mins behavioural exercise). The session will be individual therapy with a registered psychologist. The problem solving therapy intervention will progressively work through the seven steps of problem solving therapy; problem identification, selection of key problems, identifying goals, generating solutions, choosing solutions, creating a SMART (specific, measurable, achievable, relevant and time-limited) plan, and evaluating the plan, over the 6 sessions. The behavioural exercise intervention will assist participants in meeting the current Australian exercise guidelines according to age. Participants will be provided with the current recommendations for exercise and psychoeducation regarding the relationship between exercise and mood/anxiety symptoms and will receive exercise diaries and pedometers in order to record and encourage physical activity. The research psychologists will help to identify barriers and strengths for engaging in regular exercise and will monitor physical activities. Possible combinations of interventions: 1. Problem solving therapy and behavioural exercise intervention; 2. Problem solving therapy and exercise psychoeducation; 3. Supportive counselling and behavioural exercise intervention; 4. Supportive counselling and exercise psychoeducation.
Intervention code [1] 3397 0
Treatment: Other
Intervention code [2] 3398 0
Prevention
Intervention code [3] 3399 0
Behaviour
Comparator / control treatment
Supportive counselling (one session weekly for 6 weeks, approx 50 mins) and exercise psychoeducation (approx 20 mins within psychological therapy session, one-off). The duration of each session will be approximately 50 minutes of individual therapy with a registered psychologist. The supportive counselling intervention is based on general counselling principals and is guided by the recommendations in the United Kingdom's National Institute for Health and Clinical Excellence (NICE) guidelines for children and young people with mild to moderate depression. In the exercise psychoeducation condition, participants will be provided with the same written information as the participants in the active condition, however no further assistance from the clinician to engage in physical activity will be provided.
Control group
Placebo

Outcomes
Primary outcome [1] 4749 0
Primary Outcome 1: Depression and Anxiety symptoms measured by the Beck Depression Inventory-II and and Beck Anxiety Inventory
Timepoint [1] 4749 0
Timepoint: at baseline and at 6 weeks, 6 months and 12 months after intervention commencement
Primary outcome [2] 4750 0
Primary Outcome 2: Depression symptoms measured by the Montgomery Asberg Depression Rating Scale
Timepoint [2] 4750 0
Timepoint: at baseline and at 3 weeks, 6 weeks, 6 months and 12 months after intervention commencement
Secondary outcome [1] 8023 0
Secondary Outcome 1: Suicidal ideation and behaviour measures by the mean Beck Suicidal Ideation Scale
Timepoint [1] 8023 0
Timepoint: at baseline and at 3 weeks, 6 weeks, 6 months and 12 months after intervention commencement
Secondary outcome [2] 8024 0
Secondary Outcome 2: Social and occupational functioning measured by the mean Global Assessment of Functioning (GAF) Scale, the Social and Occupational Functioning Assessment Scale (SOFAS), and Aspects of Self Quesionnaire
Timepoint [2] 8024 0
Timepoint: at baseline and at 3 weeks, 6 weeks, 6 months and 12 months after intervention commencement
Secondary outcome [3] 8025 0
Secondary Outcome 3: Psychotic-like experiences as measured by the Comprehensive Assessment of At-Risk Mental States (CAARMS) questionnaire
Timepoint [3] 8025 0
Timepoint: at baseline and at 3 weeks, 6 weeks, 6 months and 12 months after intervention commencement
Secondary outcome [4] 8026 0
Secondary Outcome 4: Diet and physical activity levels measured by the Food Variety Checklist and a Physical Activity Questionnaire (based on Australian Government exercise recommendations)
Timepoint [4] 8026 0
Timepoint: at baseline and at 3 weeks, 6 weeks, 6 months and 12 months after intervention commencement
Secondary outcome [5] 8028 0
Secondary Outcome 6: Substance use scores measured by the Substances and Choices Scale (SACS clinical version)
Timepoint [5] 8028 0
Timepoint: at baseline and at 6 weeks, 6 months and 12 months after intervention commencement
Secondary outcome [6] 8029 0
Secondary Outcome 7: Treatment satisfaction measured by the Experience of Treatment Quesionnaire
Timepoint [6] 8029 0
Timepoint: at 6 weeks, 6 months and 12 months after intervention commencement
Secondary outcome [7] 8030 0
Secondary Outcome 8: Demographic variables measured by a questionnaire that addresses age, sex, family background, work history, and education level
Timepoint [7] 8030 0
Timepoint: at baseline and at 12 months after intervention commencement
Secondary outcome [8] 273323 0
Secondary Outcome 5: remission if diagnosed at baseline, measured using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), referred to as the SCID-IV.
Timepoint [8] 273323 0
Timepoint: at baseline at 6 weeks, 6 months and 12 months after intervention commencement.

Eligibility
Key inclusion criteria
Help-seeking young people aged 12-25 years who present or are referred to Western Melbourne headspace, with emerging mental health problems, defined as:
(a) Depressive/anxious symptoms of more than one week’s duration (operationalised as a score >20 on K10); OR
(b) Impaired social, vocational, educational, or family functioning (operationalised as a 20% drop in Global Assessment of Functioning (GAF) scale over past month); AND
(c) No prior treatment for depressive/anxious symptoms beyond stage 1a or 1b of the clinical staging model (McGorry et al 2006) (operationalised as estimated therapeutic levels of 4 sessions of formal psychotherapy (e.g., Cognitive Behaviour Therapy, Cognitive Analytic Therapy, Interpersonal Therapy) or 4 weeks of pharmacotherapy)
- Ability to provide informed consent
- Adequate comprehension of English to enable participation in both the interventions and assessments
Minimum age
15 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Evidence of emerging psychosis, operationalised as at least one of the following symptoms measured on the expanded Brief Psychiatric Rating Scale (exBPRS; Ventura et al 1993), rated 1 (not present) to 7 (extremely severe), present on a daily basis for at least one week: - exBPRS Item 9. Suspiciousness > 4 - exBPRS Item 10. Hallucinations >4 - exBPRS Item 11. Unusual thought content >4 - exBPRS Item 15. Conceptual Disorganization >3
- Young people with these symptoms would be referred to Orygen Youth Health’s Youth Access Team to be assessed whether the Early Psychosis Prevention and Intervention Centre (EPPIC) at Orygen Youth Health is the most appropriate service for their needs
- Specific suicidal plan or intent as defined by a score of 5 or more on the exBPRS Suicidality subscale (i.e., many fantasies about suicide, specific suicide plan, non-lethal attempt) that has been maintained for one week. Referral to treatment as usual within Western Melbourne headspace or another appropriate service will ensue
- Participants who are already engaging in levels of exercise meeting the Australian government guidelines (<18 years, 60 mins/day moderate to vigorous activity; >18 years, 30 mins moderate-intensity physical activity, most or all days
- Organic mental disorders or an estimated Intelligent Quotient <70

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)
A young person’s initial contact will be with the Access (assessment) Team at Western Melbourne (WM) headspace. Potential participants who meet the inclusion criteria will be briefly informed about the current study by the Access Team. Only the young people on the waiting list who have been assessed by either the WM headspace Access Team or by a WM headspace GP will be contacted via telephone by one of the study’s Research Assistants and offered an appointment for the purposes of obtaining informed consent and further assessment. Young people who choose not to participate in the trial will be referred to treatment as usual at WM headspace, or another appropriate service. Treatment allocation will be concealed from the baseline and outcome assessors. The research psychologists will contact the statistician after the baseline assessment and prior to the first treatment session to be informed of the participant’s treatment allocation. It will not be possible to blind the therapists and participants to group allocation for the psychosocial and exercise interventions.
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 one of four possible combinations of interventions. 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: BDI-II cut-off points; =28 mild/moderate or =29 severe) since any chance imbalances on these variables may bias the analysis, resulting in eight separate randomisation lists from which participants will be drawn. 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?



Intervention assignment
Factorial
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1154 0
3020

Funding & Sponsors
Funding source category [1] 3865 0
University
Name [1] 3865 0
University of Melbourne
Address [1] 3865 0
Locked Bag 10
Parkville VIC 3052
Country [1] 3865 0
Australia
Funding source category [2] 3866 0
Hospital
Name [2] 3866 0
Orygen Youth Health - Research Centre
Address [2] 3866 0
Locked Bag 10
Parkville VIC 3052
Country [2] 3866 0
Australia
Primary sponsor type
University
Name
Orygen Youth Health - Research Centre
Address
Locked Bag 10
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 3470 0
University
Name [1] 3470 0
University of Melbourne
Address [1] 3470 0
Locked Bag 10
Parkville VIC 3052
Country [1] 3470 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5919 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 5919 0
Human Research Ethics Committee
Office for Research
Level 6 East, Main Building
Grattan Street
Royal Melbourne Hospital VIC 3050
Ethics committee country [1] 5919 0
Australia
Date submitted for ethics approval [1] 5919 0
15/09/2008
Approval date [1] 5919 0
18/02/2009
Ethics approval number [1] 5919 0
HREC 2008.205

Summary
Brief summary
The incidence of mental illness in young people is the highest of any age group, with the onset of high prevalence disorders such as depression, anxiety and substance use peaking within the age range of 15 to 24 years. In this age group, disorders are likely to be emerging or sub-threshold, with a definitive diagnosis often difficult to make. This creates specific challenges for young people in terms of accessing appropriate youth-specific programs, treatment options, or services.

Early intervention in youth mental health aims not only to prevent the progression of a disorder but importantly to reduce the likelihood of ongoing problems with social, education, and vocational functioning. Given that mental health issues are likely to be in the early stages of disorder in this age group, it is essential that any intervention is simple yet effective and delivered in the least threatening environment. For example, milder disorders in an early stage may respond to simple measures such as psychosocial support and psychoeducation.

The proposed research aims to assess whether emerging mental health disorders in young people aged 15-25 respond to simple interventions delivered in an enhanced primary care setting. Approximately 160 young people will be randomised to receive a combination of the following treatment packages for 6 weeks:
1. Psychosocial – Problem Solving Therapy (active condition) or supportive counselling (control condition)
2. Exercise – behavioural intervention (active) or psychoeducation (control).

Clinical measures will be taken at baseline, midpoint, endpoint, and at 6 and 12 month follow-ups. The clinical data will be measured by a range of questionnaires assessing symptoms and functioning. As the current project is exploratory in nature, hypotheses will be stated as primary and secondary aims.

Primary aims
1. To evaluate whether preventively-oriented, simple treatments are acceptable and effective treatments for managing emerging mental health disorders in young people and if so,
2. Which interventions (or their combination) are most effective for various types or severities of clinical presentations

Secondary aims
3. To characterise diagnostic issues in emerging or subthreshold disorders by identifying symptom and demographic clusters which predict mental health trajectories
4. To identify possible markers in those who are likely to respond to less-complex interventions.
Trial website
Trial related presentations / publications
Parker, A. G., Hetrick, S. E., Jorm, A. F., Yung, A. R., MacKinnon, A. J., McGorry, P. D., & Purcell, R. (2011). Study protocol: The effectiveness of simple psychological and exercise interventions for high prevalence mental health problems in young people: a factorial randomised controlled trial. BMC Trials, 12, 76-84. (10/12/2013)
Public notes

Contacts
Principal investigator
Name 28928 0
Dr Alexandra Parker
Address 28928 0
Orygen Youth Health Research Centre
Locked Bag 10, Parkville
VIC 3052
Country 28928 0
Australia
Phone 28928 0
+61 3 9342 2800
Fax 28928 0
Email 28928 0
parkera@unimelb.edu.au
Contact person for public queries
Name 12085 0
Dr Dr Alexandra Parker
Address 12085 0
Locked Bag 10, Parkville VIC 3052
Country 12085 0
Australia
Phone 12085 0
+61 3 8387 2301
Fax 12085 0
+61 3 8387 2466
Email 12085 0
parkera@unimelb.edu.au
Contact person for scientific queries
Name 3013 0
Dr Dr Alexandra Parker
Address 3013 0
Locked Bag 10, Parkville VIC 3052
Country 3013 0
Australia
Phone 3013 0
+61 3 8387 2301
Fax 3013 0
+61 3 8387 2466
Email 3013 0
parkera@unimelb.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary