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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: 1. Providing a treatment-congruent treatment rationale leads to a better outcome than providing treatment-incongruent rationales. 2. Treatment-congruent explanations reduce the risk of side effect development, in particular in the medication arm. 3. Inter-individual differences in the effect of provided treatment rationale are associated with pre-treatment experiences and expectations, depression severity and comorbid anxiety.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg
Marburg, Germany
Start Date
April 13, 2021
Primary Completion Date
September 12, 2023
Completion Date
September 12, 2023
Last Updated
November 18, 2023
150
ACTUAL participants
Biological illness and treatment rationale
BEHAVIORAL
Psychological illness and treatment rationale
BEHAVIORAL
Active pharmacological placebo
DRUG
Active psychological placebo
BEHAVIORAL
Lead Sponsor
Philipps University Marburg
Collaborators
Data Source & Attribution
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