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临床试验/NCT05221567
NCT05221567已完成不适用

The Effectiveness of Intensive Psychotherapy for Chronic Depression: A Naturalistic Comparison With Treatment-as-Usual

Modum Bad0 个研究点目标入组 280 人开始时间: 2012年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Modum Bad
入组人数
280
主要终点
Change in Depressive symptoms

研究概览

简要总结

The study evaluates whether Intensive psychotherapy show superior effect on chronic depression over TAU

详细描述

Background: Accumulating evidence indicates that intensive psychotherapy (i.e., greater number of treatment sessions per time unit) improves outcomes for patients with mental health problems. However, few studies have investigated whether patients with chronic depression (CD) benefit from treatment with higher intensity. The main purpose of this study is to investigate if intensive psychotherapy could improve treatment for patients with chronic depression (CD). The primary research question is whether two intensive psychodynamic inpatient treatments, affect phobia therapy (APT) and VITA, are superior to low intensity treatment (TAU) at completion of treatment. To indicate if a potential difference between intensive treatment and TAU is due to the intensity of the therapy, the study contrasts two therapies with similar intensity, but different theoretical rationales. Methods: 280 patients with CD are included in a naturalistic study. Patients are assessed at four time points; assessment, start of therapy, end of therapy and 1-year follow-up. Three comparisons are performed with patients matched across groups; Intensive treatment (APT + VITA) vs TAU during treatment, APT vs VITA during treatment and APT vs VITA during follow-up. The outcome measure is the BDI-II.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Inclusion criteria will be liberal and similar to clinical practice criteria at the treatment site which includes patients with the characteristics of chronic depression (CD), thus including patients with
  • •Persistent depressive disorder as defined by the diagnostic and statistical manual of mental disorders (DSM5)
  • •Recurrent depressive disorder as defined by the International classification of diseases-10 (ICD-10)

排除标准

  • •Not having utilized reasonably available treatment in proximity to their residence
  • •A psychotic disorder
  • •Cluster A or B personality disorder
  • •Bipolar disorder,
  • •Ongoing substance abuse,
  • •Physical brain disorder
  • •Not having access to TAU while on the 12 week wait-list period.

研究组 & 干预措施

High intensity high dosage inpatient short-term psychodynamic psychotherapy (affect phobia therapy)

Active Comparator

APT and VITA psychotherapy was carried out in accordance with treatment manuals. In addition to weekly individual sessions the inpatient program at both groups contained two 75 min group sessions each week. In addition, VITA had shorter group meetings each morning (15 minutes). Patients in both treatments participated in two physical exercise sessions per week, weekly psycho-educational lectures and art-therapy groups, and both groups finish each week with end of the week status groups. On average, patients in both treatments received seven sessions of therapeutic activity each week. All treatment components, with the exception of the physical exercises, adhered to the APT or VITA treatments, and thus the two intensive treatments were similar in dose but different in content. Medication was managed by psychiatrists, aiming to optimize the psychotropic medication regime, typically by reducing medication use.

干预措施: Psychotherapy (Behavioral)

Treatment-as-usual

Other

TAU through public services locally, either outpatient treatment from a psychologist/psychiatrist and/or treatment/support from their local general practitioner.

干预措施: Psychotherapy (Behavioral)

High intensity high dosage inpatient short-term psychodynamic psychotherapy (VITA)

Active Comparator

APT and VITA psychotherapy was carried out in accordance with treatment manuals. In addition to weekly individual sessions the inpatient program at both groups contained two 75 min group sessions each week. In addition, VITA had shorter group meetings each morning (15 minutes). Patients in both treatments participated in two physical exercise sessions per week, weekly psycho-educational lectures and art-therapy groups, and both groups finish each week with end of the week status groups. On average, patients in both treatments received seven sessions of therapeutic activity each week. All treatment components, with the exception of the physical exercises, adhered to the APT or VITA treatments, and thus the two intensive treatments were similar in dose but different in content. Medication was managed by psychiatrists, aiming to optimize the psychotropic medication regime, typically by reducing medication use.

干预措施: Psychotherapy (Behavioral)

结局指标

主要结局

Change in Depressive symptoms

时间窗: Patients were assessed at four time points; assessment, start of therapy (12 weeks after assessment), end of therapy (24 weeks after assessment) and at 1-year follow-up (76 weeks after assessment).

Beck depression inventory II (BDI-II) Self-report instrument for assessing severity of depression. 21 items are scored on Likert scale from 0 to 4 (range 0-63). Scores between 14 and 19 indicate mild depression, 20 to 28 indicate moderate depression, and above 29 indicate major depression.

次要结局

未报告次要终点

研究者

发起方
Modum Bad
申办方类型
Other
责任方
Sponsor

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