跳至主要内容
临床试验/NCT05245370
NCT05245370已完成不适用

Social Learning Trial: Using Patient and Clinician Testimonials to Modify Treatment Expectations and Placebo Treatments in Depression

Philipps University Marburg Medical Center1 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2022年1月14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
入组人数
171
试验地点
1
主要终点
Change from baseline in scores on the Credibility and Expectancy Questionnaire (CEQ) scale

研究概览

简要总结

Research has shown that treatment expectations play a major role in the course of mental disorders and that positive expectations have a beneficial impact on treatment outcomes. Expectations can develop in different ways, whereby an emerging body of research has shown that social learning plays a significant role in this process. To date, most studies have investigated the impact of social learning on treatment expectations in the context of pain relief. Little is known about the impact of social learning in the psychotherapeutic treatment of depression. Therefore, this study investigates whether treatment expectations regarding the treatment of depression can be modulated via social learning, i.e., showing positive treatment testimonials.

Hypotheses:

H1: The investigators predict that individuals who are provided with treatment testimonials (experimental groups) show a greater change toward positive treatment expectations compared to individuals who do not view such testimonials (control groups).

H2: The investigators predict that individuals provided with treatment testimonials will, compared to the control groups, show a greater change in secondary outcome variables in the following ways: a greater decrease in perceived uncertainty/ barriers; a greater decrease in stigma/ negative attitudes toward psychotherapy; a greater increase in intentions to seek therapy; a greater willingness to try the specific technique described in the videos.

H3: Inter-individual differences in the effect of provided testimonials are associated with pre-existing factors: level of depressive symptoms; intolerance of uncertainty; treatment experience; locus of control; general self-efficacy; dispositional optimism and cognitive immunization tendencies.

Exploratory questions:

  1. An exploratory aim of this study is to assess whether viewing different types of testimonials (clinician delivered; patient-delivered; combination of both) has differential effects on treatment expectation change.
  2. Furthermore, the investigators want to assess whether implicit treatment expectations change in a similar pattern as explicit treatment expectations.
  3. Based on the results of H1 and H2, the investigators aim to assess possible mechanisms of change: e.g. assess whether a change in treatment expectations is mediated by a decrease in perceived uncertainty or a change in stigma/ attitudes toward therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • •at least 18 years old
  • •be able understand German (at least B1 level)
  • •have access to a computer device with internet access

排除标准

  • •age below 18 years old
  • •non correctable hearing or visual impairment

研究组 & 干预措施

Rationale video + clinician testimonial

Experimental

干预措施: Rationale video (Behavioral)

Rationale video + clinician testimonial

Experimental

干预措施: Clinician testimonial (Behavioral)

Rationale video + patient testimonial

Experimental

干预措施: Rationale video (Behavioral)

Rationale video + patient testimonial

Experimental

干预措施: Patient testimonial (Behavioral)

Rationale video + clinician testimonial + patient testimonial

Experimental

干预措施: Rationale video (Behavioral)

Rationale video + clinician testimonial + patient testimonial

Experimental

干预措施: Clinician testimonial (Behavioral)

Rationale video + clinician testimonial + patient testimonial

Experimental

干预措施: Patient testimonial (Behavioral)

Control group 1: Control video

Active Comparator

干预措施: Control video (Behavioral)

Control group 2: Rationale video + control video

Active Comparator

干预措施: Control video (Behavioral)

Control group 2: Rationale video + control video

Active Comparator

干预措施: Rationale video (Behavioral)

结局指标

主要结局

Change from baseline in scores on the Credibility and Expectancy Questionnaire (CEQ) scale

时间窗: Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos)

German version of the Credibility and Expectancy Questionnaire (CEQ), 6-item scale (Raeke, 2013).The CEQ consists of two subscales with four items measuring cognitive-focused credibility (e.g., "At this point, how logical does the therapy offered to you seem?") and two items measuring affect-focused expectations (e.g., "By the end of the therapy period, how much improvement in your symptoms do you really feel will occur?"). The CEQ applies different rating scales; a 9-point scale ranging from 1 (not at all) to 9 (very much) and a percentage rating scale ranging from 0% (not at all) to 100% (very much) with higher sum scores indicating greater treatment credibility and expectations.

次要结局

  • Change from baseline in scores on the Perceived Stigma subscale of the Depression Stigma Scale (DSS)(Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos))
  • Change from baseline in scores on perceived uncertainty and perceived barriers to psychotherapy(Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos))
  • Change from baseline in scores on the Treatment Expectation Questionnaire (TEX-Q)(Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos))
  • Change from baseline in scores on the subscale for treatment expectations of the the generic rating scale for previous treatment experiences, treatment expectations, and treatment effects (GEEE)(Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos))
  • Change from baseline in scores on the Self-Stigma of Depressions Scale (SSDS)(Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos))
  • Change from baseline in D-Scores on the Single-Category Implicit Associations Test (SC-IAT)(Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos))
  • Change from baseline in scores on the Credibility and Personal Reaction Scale(Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos))
  • Change from baseline in scores on the attitudes towards seeking professional psychological help scale (ATTSPPH-SF)(Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Winfried Rief

Professor, Dr.

Philipps University Marburg Medical Center

研究点 (1)

Loading locations...

相似试验