Evaluation of a Spirituality Informed E-mental Health Intervention (LEAP Project) for Major Depressive Disorder in Adolescents and Young Adults - A Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Children's Depression Rating Scale Revised (CDRS-R)
研究概览
简要总结
The purpose of this project is to explore the potential value and practicality of an innovative depression intervention for young people. More specifically, the objectives of this project are:
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to pilot the Internet-based Spirituality Program with depressed young people (age 13-24) in Calgary by:
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obtaining preliminary estimates on the impact of the program on the primary outcome of depression severity, and secondary outcomes of spiritual well-being and self-concept.
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obtaining preliminary estimates on response rates and remission rates to guide sample size estimations for a full size randomized trial.
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evaluating if the suggested research methodology is feasible with respect to recruitment rate, patient burden and clinical implementation to guide design of a full size randomized trial.
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to gather feedback from depressed young people, their families and referral sources in the community (schools, family physicians, mental health outpatient services) on the perceived value of the program and on ways to eventually make it available as a community resource for others dealing with depression.
详细描述
Depression in adolescents and young adults is a prevalent illness in Canada and presents a high burden for those affected and their families. In Canada, depressive disorders are on the rise and their onset is occurring earlier in life. There is a growing body of evidence suggesting that spiritual wellness may play a role in depression management and recovery. Considering the limitations of available treatments for depression and the significant burden of the disease there is a need for new treatment options that are safe, effective, affordable and acceptable to young people. Our previous research gives strong support to the idea of using a spiritually based intervention for depression. To our knowledge, no research has been conducted on using spirituality as a self-study intervention in the management of depression in young adults. Over the last two years our team has created a spirituality-based intervention program for adolescent depression. The program could present an innovative and low cost treatment option for young patients with major depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •13-24 years of age
- •meet DSM-IV-TR criteria for major depressive disorder (mild-moderate severity) based on the Children's Depression Rating Scale-Revised or the Hamilton Depression Rating Scale
- •ability to comply with study intervention, provision of informed assent and/or parental consent
排除标准
- •In order to avoid confounding through a change in the use of mood altering substances or therapies and through underlying medical conditions, patients will be excluded for any of the following reasons:
- •change in use of pharma-therapeutic or herbal treatment for depression in the last three month OR during the first 2 months of trial participation (mild to moderately depressed patients who have not had a change in their treatment in the last three months will be eligible to participate if it is foreseeable that their current treatment will continue unchanged for the first 2 months of trial participation)
- •patients currently undergoing a specific psycho-therapeutic treatment that has been shown to be effective for depression (such as Cognitive Behavioral Therapy (CBT) or Interpersonal Therapy (IPT)) or planning to start such therapy in the next two months
- •change in the use of medications that have mood altering effects in the last 3 months OR during the first 2 months of trial participation
- •history of bipolar disorder, psychotic disorder or psychotic episodes, personality disorder, multiple suicide attempts; history of ADD/ADHD permitted if stabilized (no longer meets DSM-IV-TR criteria for active ADD/ADHD) for at least 2 months; stabilized treated ADD/ADHD permitted if on regular long acting medication and agree to continue
- •uncontrolled medical conditions in the last 3 months (assessed by qualified physician)
- •high suicide risk
- •DSM-IV-TR diagnosis of substance dependence (except nicotine, caffeine) within past 12-months
- •history of tx resistance to ≥ 2 antidepressant medications when treated for an adequate period with a therapeutic dose
- •recent deaths in the family
结局指标
主要结局
Children's Depression Rating Scale Revised (CDRS-R)
时间窗: At 8 week intervals over a 24 week period
Measure of depression severity in individuals 13 to 18 years of age. CDRS-R total raw scores includes the sum of 17 items, each item's scoring range is from 1 (no difficulties) to 5 (severe clinically significant difficulties) or 1 (no difficulties) to 7 (severe clinically significant difficulties), with a total possible raw score ranging from 17 to 113. To meet eligibility requirements, participants required a total raw score of 40 to 70.
Hamilton Depression Rating Scale (HAMD)
时间窗: At 8 week intervals over a 24 week period
Measure of depression severity in individuals 19 to 24 years of age. HAMD total scores includes the sum of 17-items, with eight items scored on a range of 0 (absent) to 2 (marked or definite) and nine scored on a range of 0 (absent) to 4 (very severe). The level of depression was based on the following scoring ranges: 7 or under not depressed, 8-13 some depressive symptoms but no depressive disorder, 12-15 mild depression, 16-19 moderate depression, 20-24 moderately severe depression, and 25+ severe depression. To meet eligibility requirements, participants required a total score of 12-24.
次要结局
- Piers-Harris Children's Self-Concept Scale - Second Edition (Piers Harris 2)(At 8 week intervals over a 24 week period)
- Six Factor Self-Concept Scale(At 8 week intervals over a 24 week period)
- Profile of Mood States (POMS)(At 8 week intervals over a 24 week period)
- Spiritual Well-Being Scale (SWBS)(At 8 week intervals over a 24 week period)
- Spiritual Involvement and Belief Scale (SIBS)(At 8 week intervals over a 24 week period)
研究者
Patricia Steele
Executive Director, CINIM
Canadian Institute of Natural and Integrative Medicine