NCT07031804

Brief Summary

Understanding the mechanisms underlying expectation effects in the affective domain can provide valuable insights into possible therapeutic interventions for mood disorders. Studies have consistently found that expectations can influence emotional experiences. Recently, it has been shown that top-down cognitive control is critical in inducing instruction-based affective placebo effects. However, changes in the emotional system over time not only rely on higher-level cognitive processes but also on more automatic mechanisms shaped by learning and past experiences. How such mechanisms are involved in affective placebo effects is relatively unknown, but is particularly interesting in light of findings showing that previous experiences of successful treatments are an important determinant of placebo responses. This study aims to investigate the neurobehavioral mechanisms of how expectations and prior experiences modulate emotional processing. Healthy adults (N = 51, 50% women) will be recruited to participate in a cross-over fMRI study involving two conditions: positive expectation induction (placebo) and a control condition with no induced expectations. Participants will perform an emotion classification task under each condition. The investigators hypothesize that positive expectations enhance mood and improve the accuracy of recognizing happy facial expressions. Further, they hypothesize that affective expectations are represented in fMRI signal patterns in networks involved in face perception, emotional processing, and cognitive control.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 22, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

7 months

First QC Date

June 4, 2025

Last Update Submit

June 23, 2025

Conditions

Keywords

Positive expectationTreatment expectationfMRIEmotional processingPlacebo

Outcome Measures

Primary Outcomes (3)

  • Effects of positive expectation on mood

    Mood ratings via visual analogue scale (VAS), consisting of a scale from 0 to 200 points (0 meaning unhappy; 200 meaning happy). VAS will be extracted as a raw score and then normalized to the baseline VAS. It will be analyzed to assess differences between interventions (placebo and control) and to evaluate changes over time throughout the experiment.

    On both day 1 and day 2, measurements will be taken before the intervention (VAS baseline), 5 minutes after nasal spray application, and after the scanning (~ 60 minutes after nasal spray application).

  • Effects of positive expectation on task performance data

    Accuracies from the emotion classification task will be extracted and sampled for 3 emotional (happy, fearful and neutral) conditions for both interventions (Placebo and Control). Performance during the placebo condition will be regressed onto performance during the control condition for each emotion. The resulting emotion-specific psychometric response functions will allow us to disentangle expectation effects with respect to response tendencies (the intercept) and discrimination ability (the slope).

    Approximately 15 minutes after the nasal spray application, participants will perform an emotion classification task for 40 minutes while lying in the scanner on each day.

  • Effects of positive expectation on blood oxygen level dependent (BOLD) signals

    Functional magnetic resonance imaging will be used to extract and analyze BOLD signals (regions of interest and whole brain) in response to the emotional conditions and interventions. Univariate and multivariate analyses will be performed to compare activation profiles and the similarity of fMRI patterns during placebo and control.

    Approximately 15 minutes after the nasal spray application, participants will lie in the scanner for ~ 40 minutes while performing the emotion classification task on each day.

Study Arms (2)

Placebo - Control

EXPERIMENTAL

Participants in this group receive sham oxytocin on the first study day.

Other: Saline Nasal Spray

Control - Placebo

EXPERIMENTAL

Participants in this group receive sham oxytocin on the second study day

Other: Saline Nasal Spray

Interventions

A saline nasal spray will be introduced as saline on the first day (no induced expectations) and as oxytocin on the second day (induced positive expectations)

Control - Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-35 years
  • MRI compatible
  • Medical information and signed declaration of consent
  • Normal or corrected to normal vision
  • German speaking

You may not qualify if:

  • No informed consent
  • Current intake of central nervous system active drugs
  • Under influence of alcohol
  • BDI score above 12
  • Significant acute somatic or neurological diseases
  • History of psychiatric or neurological disorders
  • Pregnancy/ breastfeeding
  • Acute nasal diseases or injuries
  • fMRI data with strong artefacts or excessive movement will be excluded from analysis
  • If a participant does not believe in the treatment on the screening day, they will not be included for the main study days
  • If a participant drops out after study day one, they will be excluded from the analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf, Institute of Systems Neuroscience

Hamburg, Hamburg, 20251, Germany

Location

Related Publications (2)

  • Mostauli A, Rauh J, Gamer M, Buchel C, Rief W, Brassen S. Placebo treatment entails resource-dependent downregulation of negative inputs. Sci Rep. 2025 Mar 17;15(1):9088. doi: 10.1038/s41598-025-93589-y.

    PMID: 40097556BACKGROUND
  • Baker J, Gamer M, Rauh J, Brassen S. Placebo induced expectations of mood enhancement generate a positivity effect in emotional processing. Sci Rep. 2022 Mar 29;12(1):5345. doi: 10.1038/s41598-022-09342-2.

    PMID: 35351936BACKGROUND

Study Officials

  • Stefanie Brassen, Prof. Dr.

    Department of Systems Neuroscience, University Hospital Hamburg-Eppendorf, Hamburg, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefanie Brassen, Prof. Dr.

CONTACT

Lena Szabo, M.Sc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blinded to the real substance (saline nasal spray).
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: A cross-over design will be employed by giving a saline nasal spray introduced either as oxytocin or as saline.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

June 4, 2025

First Posted

June 22, 2025

Study Start

June 1, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
With Publication

Locations