NCT06251284

Brief Summary

Understanding the mechanisms of expectation effects in the affective system is vital, given high placebo rates in antidepressants. Evidence has consistently confirmed that expectations can influence our emotional experience. Recently, a crucial role of prefrontal top-down regulation and cognitive capacity was shown in verbally instructed expectation effects within the affective system. Empirical findings systematically point to a positivity effect in emotionally healthy aging, linked to prefrontal functioning. It is unclear whether the effects and mechanisms of positive expectations on emotional processing might also change throughout the lifespan. Hence, the investigators' goal is to explore the neurobehavioral mechanisms underlying positive expectation effects in healthy aging. Healthy older adults (N=55; 50% female) will be invited to a cross-over (positive expectation vs. no expectations induced) fMRI experiment during which they will perform an emotional interference task that manipulates cognitive resources. The investigators hypothesize that older adults demonstrate a resource-dependent positivity effect and that this effect will be further enhanced through the induction of positive expectations. Additionally, it is expected that these result are related to participants' general cognitive control ability and to be reflected on the corresponding neural correlates in prefrontal-limbic networks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

8 months

First QC Date

January 24, 2024

Last Update Submit

December 6, 2024

Conditions

Keywords

Positive expectationfMRIAttentional mechanismsCognitive controlAging

Outcome Measures

Primary Outcomes (3)

  • Effects of positive expectation on mood

    Mood ratings via visual analogue scale (VAS), consisting of a scala from 0 to 400 points (0 meaning unhappy; 400 meaning happy). VAS will be extracted as a raw score and then normalized to the baseline VAS. It will be analyzed following the time course of the experiment and as an average of the VAS measured during the scanner on each day.

    Before the intervention (VAS baseline), after 10 minutes, after 25 minutes, after 40 minutes and after the scanning (55 minutes after the baseline) on each day.

  • Effects of positive expectation on reaction time data

    Reaction times from the emotional interference task will be extracted and sampled for 5 emotional (happy, fearful, sad, neutral and scrambled faces) and 2 attention (high and low attention to faces) conditions and their interaction.

    After the intervention, participants will performed this task during 45 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 (whole brain and regions of interest) in response to the emotional and attention conditions and their interaction.

    Participants will lie in the scanner for approximately 45 minutes while performing the emotional interference task, after the intervention on each day.

Secondary Outcomes (1)

  • Fixation and gaze shifts behaviors (eye-tracking)

    Participants fixation patterns will be recorded during the performance of the emotional interference task (for 45 minutes) 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 - PlaceboPlacebo - Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged above 60 years
  • MRI compatible
  • Medical information and signed declaration of consent
  • No history of psychiatric or neurological disorders

You may not qualify if:

  • Current intake of central nervous system active drugs
  • Montreal Cognitive Assessment (MoCA) score below 26
  • BMI score above 30
  • BDI score above 12

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Systems Neuroscience

Hamburg, Hamburg, 20246, Germany

Location

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

January 24, 2024

First Posted

February 9, 2024

Study Start

November 1, 2023

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

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

Locations