Randomized Trial of Treatment of Depression With Interpersonal Psychotherapy and Cognitive Behavioral Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Montgomery Asberg Depression Rating Scale (MADRS) ( Montgomery SA & Åsberg M. Br J Psychiatry 1979; 134:382-9)
研究概览
简要总结
In this study, the differential effectiveness of CBT and IPT for patients with Major Depressive Disorder, who rate their depression as mild or moderate, will be studied. Both methods are evidence based and recommended by the National Board of Health in Sweden. They are manual based and the patients will receive 14 sessions in each therapy. Their comparative effectiveness has not been studied in Sweden, and their effectiveness with regard to work capacity has not been tested. The hypotheses in the study are that they have equal effect for depression remission, but that CBT is superior when return to work is measured. Three moderator analyses, testing effects for different subgroups, will be made. They propose that patients with attachment avoidance and lower mentalization ability and male patients will have better outcome with CBT. The study will be performed at Sundsvall Hospital, in cooperation with Linköping University. Sundsvall hospital is the only hospital in Sweden where there is a group IPT therapists large enough to make a controlled study possible. The study has a randomized design, with 16 therapists, 8 of them delivering CBT and 8 IPT. The number of patients is 96. The statistical power is .87, with a hypothesized between-groups effect size of d = .40 for return to work, and the significance level of .05 for the between-groups difference. Outcome will be measured as remission of psychiatric diagnosis, decrease in depression severity and frequency of patients who return to work. Both intent-to-treat and completers analyses will be made. The project will go over two years. The study has an effectiveness character in the sense that treatments, although manual based, will be performed in the manner that the therapists usually work, and by having broad inclusion criteria. Treatment integrity will be ascertained by therapist reports and by filming sessions.
详细描述
The main purpose of the study is to analyze whether Interpersonal psychotherapy (IPT) and Cognitive Behavioural Therapy (CBT) are effective psychotherapies for depressed patients, with respect to changes in working capacity and psychiatric diagnosis. A secondary purpose is to study moderating factors in the two methods. The study has a randomized design. It will be performed at the Psychiatric Clinic in Sundsvall.
The differences in effect between different forms of psychotherapy for depression, when reduction in symptoms is used as outcome criterion, are rather small. In a recent meta-analysis, differences in efficacy between seven forms of psychotherapy were compared (Cuijpers, van Straten, Andersson & van Oppen, 2008). The efficacy was on the whole the same.
In the guidelines from National Board of Health and Welfare in Sweden, CBT and IPT are recommended as the first hand choices for treatment of mild and moderate depression. This recommendation is based on studies from other countries. Comparative randomized studies of CBT and IPT have not been published in Sweden.
Hypotheses The main hypotheses in this study is that CBT and IPT are both effective treatments for Major Depressive Disorder, and that they have equal effects with regard to remission from depression, but that CBT is more effective than IPT when return to employment is the outcome measure. Three moderator hypotheses will be tested. The first moderator hypothesis is that patients with attachment avoidance get better results with CBT, whereas patients with attachment anxiety get better results with IPT. The second hypothesis is that patients with higher RF get better results with IPT than with CBT. The third moderator hypothesis is that women respond better to IPT and men to CBT, particularly if relational functioning is considered. In the moderator hypotheses, both remission from depression and return to work will be outcome criteria.
Method Participants Patients who seek treatment with the diagnosis Major Depressive Disorder (MDD), and who indicate mild or moderate depression on Beck's Depression Inventory will be asked to participate. The inclusion criterion is thus Major depressive disorder with mild or moderate severity. Exclusion criteria are psychosis, ongoing drug abuse, serious neuropsychiatric disorder, personality disorder cluster B. Patients with severe depression will also be excluded. We will also exclude patients who have used the disability pension and only include patients who have sickness benefit, as it is improbable the psychotherapy with 14 sessions will be enough for patients with disability pension. There will be no treatment arm with only medication. Ongoing medication is no obstacle for participation, but changes in medication will be avoided if possible. Medication will be registered. The patients will be randomized to the treatment alternatives. In all, 96 patients will take part in the study.
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
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •major depression
排除标准
- •psychosis
- •addiction
- •bipolar disorder
- •active self harm
- •severe attention deficit hyperactivity syndrome
- •disability pension
结局指标
主要结局
Montgomery Asberg Depression Rating Scale (MADRS) ( Montgomery SA & Åsberg M. Br J Psychiatry 1979; 134:382-9)
时间窗: Change from before treatment to after termination (14-15 weeks)
Clinician-rated depression symptoms before and after therapy
Return to Work
时间窗: Change from before treatment and after termination (14-15 weeks).
Sick leave will be measured by medical records and by checking the insurance system
次要结局
未报告次要终点
研究者
Annika Ekeblad
clinical psychologist, PhD student
Linkoeping University
