Clinical and Economic Evaluation of Neurocognitively-Enhanced Online Cognitive Behavioural Therapy to Promote Functional Recovery Among Community-Living Individuals With Depression: OPTM Study (Online Psychological Treatments for Low Mood)
试验速览
- 阶段
- 不适用
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Depressive symptoms at end of treatment
研究概览
简要总结
To evaluate the clinical efficacy of online cognitive behavioural therapy supplemented with online neurocognitive remediation therapy to improve mood and cognition, decrease relapse rates and optimise work and occupational functioning.
详细描述
Depression is the most prevalent mental disorder with high relapse rates. Direct costs to Europe represent 1% of its total economy. Following usual treatment, mood improves or fully recovers but cognitive deficits often persist, preventing full return to normal social function. These deficits worsen with repeated depressive episodes and are a significant predictor of relapse. Preventing depression relapse remains one of the biggest therapeutic challenges in the field. While effective short-term therapies, such as cognitive behavioural therapy (CBT), exist, all are associated with high relapse rates. Online neurocognitive remediation therapy (oNCRT), by its potential to rehabilitate impaired cognition in depression, offers an innovative solution to this mental health problem.
This trial aims to test the effectiveness and cost-effectiveness of neurocognitively enhanced online CBT to improve mood and cognition in depression, optimise everyday functioning and prevent depression relapse over six months follow-up, using a randomised active-control parallel-groups research design. Individuals presenting with at least mild depression (n=134) are randomly assigned to one of two treatment allocations: online CBT (oCBT) or neurocognitively enhanced online CBT (oCBT+oNCRT) for 20 one-hour sessions over 5 weeks (i.e., four weekly sessions).
Before randomisation and within a week of the final allocated session, mood, attention, memory and planning abilities will be assessed. All participants will be then followed for six-months to determine if the mood and cognitive benefits of the oCBT+oNCRT are maintained with the passage of time compared to the control group (oCBT alone). Standard measures of daily functioning (e.g., work ability, occupational function) and economic cost-effectiveness data will be obtained at the same time points. Demonstrating the oNCRT effectiveness as an adjunct to CBT will contribute towards optimising connected healthcare solutions for 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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scoring a minimum of 14 on the BDI-II,
- •internet access
- •computer access
- •English-speaking fluency
排除标准
- •scoring less than 14 on BDI
结局指标
主要结局
Depressive symptoms at end of treatment
时间窗: through study completion, an average of 1 year
The Beck's Inventory for Depression - II (BDI-II; Beck et al., 1996) assesses the self-report severity of currently experienced depressive symptoms. The total score of 21 items is used.The scale score ranges 0 to 63, with higher values indicating more severe depression. Scores are to be interpreted as follows: 0-8: no depression; 9-13: subsyndromal depressive symptoms; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.
Relapse rates at 6 months follow-up
时间窗: through study completion, an average of 1 year
Percent individuals, whose Beck's Inventory for Depression - II score at end of treatment was below 14, but returned to above 14 at 6-months follow-up
次要结局
- Verbal working memory (cognitive outcome 5)(through study completion, an average of 1 year)
- Planning ability (cognitive outcome 6)(through study completion, an average of 1 year)
- Work and Social Adjustment (occupational outcome 1)(through study completion, an average of 1 year)
- Inhibition ability (cognitive outcome 3)(through study completion, an average of 1 year)
- Immediate verbal memory (cognitive outcome 1)(through study completion, an average of 1 year)
- Flexibility ability (cognitive outcome 4)(through study completion, an average of 1 year)
- Costs Associated with Mental Healthcare (economic main assessment)(through study completion, an average of 1 year)
- Delayed verbal memory (cognitive outcome 2)(through study completion, an average of 1 year)
研究者
Maria Semkovska
Principal Investigator of OPTM Study
University of Southern Denmark