CompletedPhase 4ACTRN12608000550303

The acceptability and effectiveness of simple interventions in reducing mental health problems in help-seeking young people

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


Sponsor

Orygen Youth Health - Research Centre

Enrollment

160 participants

Start Date

Apr 6, 2009

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 15 YearssMax Age: 25 Yearss

Inclusion Criteria6

  • 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

Exclusion Criteria5

  • 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

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Interventions

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 3

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.


Locations(1)

Australia

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ACTRN12608000550303