The Modulatory Role of Communicated Treatment Rationale on Treatment Expectation Effects in Depression.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in depression severity scores after 4 weeks of treatment - 'Montgomery Asberg Depression Scale' (MADRS)
研究概览
简要总结
Placebo groups in clinical trials on depression show impressive improvements. Yet, there is little research on the mechanism underlying this effect. The aim of this study is to assess how patients' treatment expectations modulate the placebo treatment effects.
We expect that patients' treatment expectation determines placebo responses and treatment outcomes, and that this expectation is influenced by the disorder explanations (information about the illness models) typically provided during the initial medical encounters that precede treatment.
In the study we aim to manipulate depressed patients' expectations by providing two different clinician-delivered illness and treatment rationales (biological/ psychological). Patients will then receive placebo treatment (pharmacological/ psychological), that is either congruent or incongruent with the previously communicated treatment rationale.
Hypotheses:
- Providing a treatment-congruent treatment rationale leads to a better outcome than providing treatment-incongruent rationales.
- Treatment-congruent explanations reduce the risk of side effect development, in particular in the medication arm.
- Inter-individual differences in the effect of provided treatment rationale are associated with pre-treatment experiences and expectations, depression severity and comorbid anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants will be blinded to the congruency condition. Outcome assessors (diagnosticians) will be blinded to treatment allocation and the congruency condition (both at the pre-measurement and at the post-measurement). The clinicians (care providers) who deliver the illness explanation and treatment rationale will be blinded to the participants' treatment allocation up to the point at which the respective treatment is delivered. This means that the clinician provides the treatment rationale (biological / psychological) without knowledge of whether a congruent or incongruent treatment will be delivered afterwards. The staff members who deliver the treatment (care providers) will be different to the clinician who delivers the rationales. Thus the treatment will be delivered without knowledge of whether a congruent or incongruent illness explanation was given.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of major depression according to the 'Structured Clinical Interview for DSM-V' (SCID)
- •Comorbidity is allowed if major depression is the dominant clinical problem
- •Concordant medication is allowed if kept constant for the four weeks before and until the end of the trial (with the exception of benzodiazepines and if not contraindicated together with Buscopan)
- •Fluency in German
- •Informed consent
排除标准
- •Severe depression (BDI> 30) or suicidality
- •Psychosis
- •Significant neurological diseases
- •Other mental or physical disorder with substantial influence on disability
- •Benzodiazepine intake
- •Any intolerance against Buscopan and sucrose or any medical condition/treatment conflicting with Buscopan intake
研究组 & 干预措施
1. Congruent Rationale & Treatment: Biological/Pharmacol.
Participants receive a biological illness explanation and treatment rationale. During treatment they receive a placebo pill (Buscopan).
干预措施: Biological illness and treatment rationale (Behavioral)
1. Congruent Rationale & Treatment: Biological/Pharmacol.
Participants receive a biological illness explanation and treatment rationale. During treatment they receive a placebo pill (Buscopan).
干预措施: Active pharmacological placebo (Drug)
2. Incongruent Rationale & Treatment: Psychological/Pharmacol.
Participants receive a psychological illness explanation and treatment rationale. During treatment they receive a placebo pill (Buscopan).
干预措施: Psychological illness and treatment rationale (Behavioral)
2. Incongruent Rationale & Treatment: Psychological/Pharmacol.
Participants receive a psychological illness explanation and treatment rationale. During treatment they receive a placebo pill (Buscopan).
干预措施: Active pharmacological placebo (Drug)
3. Congruent Rationale & Treatment: Psychological/Psychol.
Participants receive a psychological illness explanation and treatment rationale. During treatment they receive a placebo psychological treatment (emotional writing).
干预措施: Psychological illness and treatment rationale (Behavioral)
3. Congruent Rationale & Treatment: Psychological/Psychol.
Participants receive a psychological illness explanation and treatment rationale. During treatment they receive a placebo psychological treatment (emotional writing).
干预措施: Active psychological placebo (Behavioral)
4. Incongruent Rationale & Treatment: Biological/Psychol.
Participants receive a biological illness explanation and treatment rationale. During treatment they receive a placebo psychological treatment (emotional writing).
干预措施: Biological illness and treatment rationale (Behavioral)
4. Incongruent Rationale & Treatment: Biological/Psychol.
Participants receive a biological illness explanation and treatment rationale. During treatment they receive a placebo psychological treatment (emotional writing).
干预措施: Active psychological placebo (Behavioral)
结局指标
主要结局
Change in depression severity scores after 4 weeks of treatment - 'Montgomery Asberg Depression Scale' (MADRS)
时间窗: Baseline, post-treatment (4 weeks after start of treatment)
Expert rating to assess depression severity; 10 items; each item is rated on a 7-point scale (0-6); total scores range between 0-60 (higher scores indicate more severe depression)
次要结局
- Change in subjective disability scores after 4 weeks of treatment - adaptation of 'Pain Disability Index' (PDI)(Pre-treatment (2-7 days after baseline), post-treatment (4 weeks after start of treatment), and at follow-up (1 week later))
- Change in treatment expectations at the start of treatment - 'Treatment Expectation Questionnaire' (TEX-Q)(Baseline, pre-treatment (2-7 days after baseline))
- Change in subjective stress scores after 4 weeks of treatment - 'Perceived Stress Scale' (PSS-10)(pre-treatment (2-7 days after baseline), post-treatment (4 weeks after start of treatment), and at follow-up (1 week later))
- Change in anxiety scores after 4 weeks of treatment - 'State-Trait-Anxiety- Depression-Inventory' (STADI)(State scale: Baseline; pre-treatment (2-7 days after baseline), post-treatment (4 weeks after start of treatment) and at follow-up (1 week later); Trait scale only measured at baseline)
- Change in depressive symptom scores after 4 weeks of treatment- 'Beck Depression Inventory' (BDI-II)(Baseline, post-treatment (4 weeks after start of treatment), and at follow-up (1 week later))
- Change in 'Generic Assessment of Side-Effects' scores (GASE) after 4 weeks of treatment(Pre-treatment (2-7 days after baseline), post-treatment (4 weeks after start of treatment), and at follow-up (1 week later))
研究者
Winfried Rief
Prof. Dr.
Philipps University Marburg Medical Center