Evidence map›Paper›PMID 37592320›Full record

ArticleTrials2023

The role of the communicated treatment rationale on treatment outcome: study protocol for a randomized controlled trial.

Liv Henrich, Marcel Wilhelm, Philipp Lange, Winfried Rief

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04719663 (The Modulatory Role of Communicated Treatment Rationale on Treatment Expectation Effects in Depression.), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04719663 nacompletednot on this map

The Modulatory Role of Communicated Treatment Rationale on Treatment Expectation Effects in Depression.

TypeinterventionalSponsorPhilipps University MarburgRan2021 to 2023Enrolled150ConditionsCondition: Major Depressive Disorder (MDD)ArmsBiological illness and treatment rationale, Psychological illness and treatment rationale, Active pharmacological placebo, Active psychological placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Liv HenrichDepartment of Psychology, Division of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Gutenbergstraße 18, 35032, Marburg, Germany. liv.henrich@uni-marburg.de.ORCID http://orcid.org/0009-0004-5301-9060
Marcel WilhelmDepartment of Psychology, Division of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Gutenbergstraße 18, 35032, Marburg, Germany.
Philipp LangeDepartment of Psychology, Division of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Gutenbergstraße 18, 35032, Marburg, Germany.
Winfried RiefDepartment of Psychology, Division of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Gutenbergstraße 18, 35032, Marburg, Germany.

Funding

Deutsche Forschungsgemeinschaft (DFG) 422744262-TRR 289
6 · The paper itself

Abstract

backgroundPlacebo effects are a well-established phenomenon in the treatment of depression. However, the mechanism underlying these effects are not fully understood. Treatment expectations are considered one explanation for why placebos work. Treatment expectations are likely to be affected by clinician-patient interactions. This study aims to investigate the role of the communicated treatment rationale in modulating treatment expectations and its effects on the treatment outcomes of a pharmacological and a psychological active placebo intervention for depression. In this study, treatment expectations are modulated by presenting illness models that are either congruent or incongruent with the treatment intervention that follows.

methodsThis 2 × 2 randomized controlled trial will involve patients with major depression. Participants will either receive a biological or a psychological illness model from a clinician. Following this, they are randomly assigned to receive either a pharmacological or a psychological active placebo intervention. The illness model and the treatment are either congruent or incongruent with each other, resulting in four groups. In addition, a natural course control group will be included. DISCUSSION: This study will provide insights into the mechanism of expectation modulation in active placebo treatments for major depression. The results may provide insights for clinicians to improve their communication with patients by focusing on treatment expectations. By identifying the factors that contribute to placebo effects, this study has the potential to improve the effectiveness of existing depression treatments and reduce the burden of this highly prevalent mental health condition.

trial registrationThis trial has been registered prospectively at ClinicalTrials.gov under the identifier: NCT04719663. Registered on January 22, 2021.

Indexed as

Major Depressive DisorderManipulation, OsteopathicCommunicationControl GroupsHumansModels, PsychologicalRandomized Controlled Trials as TopicAdultsDepressionPharmacological placeboPsychological placeboTreatment expectationsTreatment rationale

Identifiers

PMID37592320
PMCPMC10433650

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.