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BackgroundSleep problems are a major risk factor for the emergence of depression in adolescence. The aim of this study was to test whether an intervention for improving sleep habits could prevent the emergence of depression, and improve well-being and cardiovascular indices amongst at-risk adolescents.
Methods/Design
A longitudinal randomised controlled trial (RCT) is being conducted across Victorian Secondary Schools in Melbourne, Australia. Adolescents (aged 12–17 years) were defined as at-risk for depression if they reported high levels of anxiety and sleep problems on in-school screening questionnaires and had no prior history of depression (assessed by clinical diagnostic interview). Eligible participants were randomised into either a sleep improvement intervention (based on cognitive behavioral and mindfulness principles) or an active control condition teaching study skills. Both programs consisted of seven 90 minute-long sessions over seven weeks. All participants were required to complete a battery of mood and sleep questionnaires, seven-days of actigraphy, and sleep diary entry at pre- and post-intervention. Participants also completed a cardiovascular assessment and two days of saliva collection at pre-intervention. Participants will repeat all assessments at two-year follow up (ongoing).
Discussion
This will be the first efficacy trial of a selective group-based sleep intervention for the prevention of depression in an adolescent community sample. If effective, the program could be disseminated in schools and greatly improve health outcomes for anxious adolescents.
BackgroundSleep problems are a major risk factor for the emergence of depression in adolescence. The aim of this study was to test whether an intervention for improving sleep habits could prevent the emergence of depression, and improve well-being and cardiovascular indices amongst at-risk adolescents.
Methods/Design
A longitudinal randomised controlled trial (RCT) is being conducted across Victorian Secondary Schools in Melbourne, Australia. Adolescents (aged 12–17 years) were defined as at-risk for depression if they reported high levels of anxiety and sleep problems on in-school screening questionnaires and had no prior history of depression (assessed by clinical diagnostic interview). Eligible participants were randomised into either a sleep improvement intervention (based on cognitive behavioral and mindfulness principles) or an active control condition teaching study skills. Both programs consisted of seven 90 minute-long sessions over seven weeks. All participants were required to complete a battery of mood and sleep questionnaires, seven-days of actigraphy, and sleep diary entry at pre- and post-intervention. Participants also completed a cardiovascular assessment and two days of saliva collection at pre-intervention. Participants will repeat all assessments at two-year follow up (ongoing).
Discussion
This will be the first efficacy trial of a selective group-based sleep intervention for the prevention of depression in an adolescent community sample. If effective, the program could be disseminated in schools and greatly improve health outcomes for anxious adolescents.
BackgroundThe primary objective of this randomised controlled trial (RCT) is to establish the effectiveness of a novel online quality of life (QoL) intervention tailored for people with late stage (≥ 10 episodes) bipolar disorder (BD) compared with psychoeducation. Relative to early stage individuals, this late stage group may not benefit as much from existing psychosocial treatments. The intervention is a guided self-help, mindfulness based intervention (MBI) developed in consultation with consumers, designed specifically for web-based delivery, with email coaching support.
Methods/design
This international RCT will involve a comparison of the effectiveness and cost-effectiveness of two 5-week adjunctive online self-management interventions: Mindfulness for Bipolar 2.0 and an active control (Psychoeducation for Bipolar). A total of 300 participants will be recruited primarily via social media channels. Main inclusion criteria are: a diagnosis of BD (confirmed via a phone-administered structured diagnostic interview), no current mood episode, history of 10 or more mood episodes, no current psychotic features or active suicidality, under the care of a medical practitioner. Block randomisation will be used for allocation to the interventions, and participants will retain access to the program for 6 months. Evaluations will be conducted at pre- and post- treatment, and at 3- and 6- months follow-up. The primary outcome measure will be the Brief Quality of Life in Bipolar Disorder Scale (Brief QoL.BD), collected immediately post-intervention at 5 weeks (T1). Secondary measures include BD-related symptoms (mania, depression, anxiety, stress), time to first relapse, functioning, sleep quality, social rhythm stability and resource use. Measurements will be collected online and via telephone assessments at baseline (T0), 5 weeks (T1), three months (T2) and six months (T3). Candidate moderators (diagnosis, anxiety or substance comorbidities, demographics and current treatments) will be investigated as will putative therapeutic mechanisms including mindfulness, emotion regulation and self-compassion. A cost-effectiveness analysis will be conducted. Acceptability and any unwanted events (including adverse treatment reactions) will be documented and explored.
Discussion
This definitive trial will test the effectiveness and cost-effectiveness of a novel QoL focused, mindfulness based, online guided self-help intervention for late stage BD, and investigate its putative mechanisms of therapeutic action.