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临床试验/NCT02667366
NCT02667366Unknown不适用

Improving Access to Evidence-based Treatment for Depression: Effectiveness and Cost-effectiveness of Telephone-delivered Cognitive Behavioral Therapy (CBT) in Primary Care

University of Zurich1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2016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
入组人数
56
试验地点
1
主要终点
Change in depressive symptoms

研究概览

简要总结

The aim of the study is the examination of effectiveness and cost-effectiveness of a telephone-based psychotherapy (Tel-PT) for depression compared to treatment as usual in primary care.

详细描述

The overall purpose of the study is to examine the effectiveness of telephone psychotherapy (Tel-PT) for the treatment of mild to moderate depression on different outcome-levels and under clinically representative conditions in Swiss primary health care. The randomized-controlled trial (RCT) will evaluate the primary hypothesis that Tel-PT is more effective than routine primary care (i.e. treatment as usual, TAU), more specifically, that it leads to significant higher reduction in depression severity than TAU at follow-up.

The intervention group (IG) receives a manualized short-term cognitive behavioral treatment, which is the adapted German version of the program "Creating a balance" developed in the USA. The therapy consists of one face-to-face and 8-12 telephone contacts and is carried out by a licensed psychotherapist.

More concrete, recruitment and inclusion of the patients will be carried out by the participating general practitioners (GPs). GPs will be instructed to screen patients at risk for depression, especially those revealing diffuse somatic symptoms and suffering from chronic diseases. If positively screened, patient's depressive symptoms are assessed with Patient Health Questionnaire (PHQ-9) and diagnosed according to ICD-10.

All GPs will receive an initial training prior to their participation, providing them with study information and procedures as well as training in screening procedure, psychodiagnostics and study enrolment.

Eligible patients are provided with detailed study information and asked to participate. Subsequently, patients will give informed consent. Patients will then be included into the study and fill out the baseline questionnaires (t0). After that, randomization will be carried out at the University of Zurich, based on an appropriately created computer algorithm. Both GPs and patients are informed about the results by the study team within two days. Subsequently, patients in control group (CG) will receive regular text messages and patients in the intervention group (IG) will be called by the study therapist to schedule an initial appointment.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •PHQ-9 score of > 5 and ≤
  • •Informed Consent as documented by signature (Appendix Informed Consent Form)
  • •Minimum age of 18 years
  • •Diagnosis of mild to moderate depression according to ICD-10 (F32.0, F32.1, F33.0, F33.1)

排除标准

  • •Patients currently being in psychotherapeutic treatment or treatment in past three months
  • •Suicidal tendencies or suicidality
  • •Insufficient knowledge of German language
  • •Health condition that does not allow questionnaire completion

研究组 & 干预措施

Tel-PT

Experimental

Tel-PT receives a manualized short-term CBT. Treatment consists of one initial face-to-face appointment and 8-12 subsequent telephone sessions between patient and licensed therapist. Each telephone contact lasts between 20 and 30 minutes and take place on a weekly and later biweekly basis.

干预措施: Tel-PT (Behavioral)

TAU and text messages

Active Comparator

Control Group receives treatment as usual and additionally weekly text messages containing general information about depression.

干预措施: TAU and text messages (Behavioral)

结局指标

主要结局

Change in depressive symptoms

时间窗: t0 (baseline) and t2 (12 months after baseline)

The change in depressive symptoms will be assessed with the German version of Patient Health Questionnaire (PHQ-9; Löwe, Spitzer, Zipfel, \& Herzog 2002).

次要结局

  • Cost-effectiveness(t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline))
  • Change in depressive symptoms(t0 (baseline) and t1 (four months after baseline))
  • Response(t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline))
  • Change in health-related quality of life(t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline))
  • Self-efficacy for management and relapse prevention in depression(t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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