Low Intensity Versus Self-guided Internet-delivered Psychotherapy for Major Depression: a Multicenter, Controlled, Randomised Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 10
- 主要终点
- Severity of depressive symptomatology measured by Beck Depression Inventory II
研究概览
简要总结
BACKGROUND: Major depression will become the second most important cause of disability in 2020. Computerised cognitive-behaviour therapy could be an efficacious and cost-effective option for its treatment. No studies on cost-effectiveness of low intensity vs self-guided psychotherapy have been carried out.
AIM: To assess the efficacy of low intensity vs self-guided psychotherapy for major depression in the Spanish health system.
METHODS: The study is made up of 3 phases: 1.- Development of a computerised cognitive-behaviour therapy for depression tailored to Spanish health system. 2.- Multicenter controlled, randomized study: A sample (N=450 patients) with mild/moderate depression recruited in primary care. They should have internet availability at home, not receive any previous psychological treatment, and not suffer from any other severe somatic or psychological disorder. They will be allocated to one of 3 treatments: a) Low intensity Internet-delivered psychotherapy + improved treatment as usual (ITAU) by GP, b) Self-guided Internet-delivered psychotherapy + ITAU or c) ITAU. Patients will be diagnosed with MINI psychiatric interview. Main outcome variable will be Beck Depression Inventory. It will be also administered EuroQol 5D (quality of life) and Client Service Receipt Inventory (consume of health and social services). Patients will be assessed at baseline, 3 and 12 months. An intention to treat and a per protocol analysis will be performed.
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
- Double (Participant, Investigator)
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
- •Diagnosis of major depression. It will be carried out with MINI International Neuropsychiatric Interview + scoring of moderate or mild depression using Beck Depression Inventory II. Cut-off point for this questionnaire is: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression [34, 35].
- •Aged 18-65 years
- •Able to understand and read Spanish
- •Moderate or mild major depression
- •Duration of symptoms longer than 2 weeks
- •Access to Internet at home and having an email address.
排除标准
- •Any psychological treatment during last year
- •Severe psychiatric disorder in Axis I (alcohol/substances abuse or dependence, psychotic disorders or dementia)patients with severe depression (indicated by a Beck-II score of 29 or higher) who will be advised to consult their GP Receiving pharmacological treatment with antidepressants is not an exclusion criteria meanwhile, during the study period, treatment will not be modified or increased (decrease of pharmacological treatment is accepted).
结局指标
主要结局
Severity of depressive symptomatology measured by Beck Depression Inventory II
时间窗: 12 months after completing the psychotherapy program
This is one of the most widely questionnaires used to evaluate severity of depression in pharmacological and psychotherapy trials. This questionnaire has been used because it is recommended to assess depression in primary care patients in which comorbidity with medical disorders is frequent. The Spanish validated version of the questionnaire will be used.
次要结局
- Client Service Receipt Inventory - adapted (CSRI - Spanish version)(12 months after completing the psychotherapy program)
- Positive and Negative Affect Scale (PANAS)(12 months after completing the psychotherapy program)
- Mini-International Neuropsychiatric Interview (MINI).(At Baseline)
- EuroQoL-5D questionnaire (EQ-5D - Spanish version)(12 months after completing the psychotherapy program)
- Socio-demographic variables.(At Baseline)
- Overall Depression Severity and Impairment Scale(12 months after completing the psychotherapy program)
- Credibility/expectancy questionnaire(At Baseline)
研究者
Javier Garcia Campayo
Principal Investigator
Hospital Miguel Servet