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Expectation Effects on Emotional Processing in Late LifeNCT06251284

Expectation Effects on Emotional Processing in Late Life

A study testing Saline nasal spray in people with Expectation Effects on Emotional Processing in Late Life, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
What is being tested?
Saline nasal spray
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteGermany
Study dates
1 Nov 2023to 1 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • Department of Systems Neuroscience

    Hamburg, Free and Hanseatic City of Hamburg, 20246

Other trials in Germany

About this study

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.

Read the detailed description

Understanding the mechanisms of expectation effects on mood states and emotion processing can be crucial to develop depression treatment strategies. Evidence has related positive expectations to a perception bias towards positive information and changes in neural networks of affective processing. In a recent study conducted by our group, the investigators showed that verbally instructed positive expectations in healthy young adults improved subjective mood, reduced distractibility by aversive stimuli and activated top-down regulation processes in neural networks of emotion regulation. Moreover, these findings were related to cognitive control ability, mediated by prefrontal-parietal networks involved in attentional orienting. Together, these results emphasize the crucial role of top-down control regulation processes and cognitive capacity in verbally instructed expectation effects within the affective system. Additionally, evidence has frequently pointed to a positivity effect in emotionally healthy aging, linked to prefrontal functioning. This suggests that older adults tend to focus more on positive information compared to younger adults. It is unclear whether the effects and mechanisms of positive expectations on emotional processing change throughout the lifespan, assuming age-related alterations might affect neural networks responsible for emotional regulation and cognitive control in expectation effects. Therefore, the aim of this study is to investigate whether older adults also benefit from positive expectations and which neurobehavioral mechanisms and brain areas are related to this phenomenon.

Applying our previously established experimental setup, in this study, the investigators will invite 55 older healthy adults to participate in two fMRI sessions. During an initial screening, participants will complete demographic and psychometric questionnaires (Beck Depression Inventory (BDI) and previous experience with oxytocin). In addition, cognitive healthiness will be ensured via the Montreal Cognitive Assessment (MoCA) and participants will perform a visual search task to assess cognitive control ability (Singleton Task).

On two study days (separated by ~ 1 week), participants will undergo fMRI scanning. Before scanning, they will receive a saline nasal spray, introduced as oxytocin ("oxytocin" condition) or saline ("control" condition) in a counterbalanced cross-over design. Positive expectations about oxytocin will be induced by a custom 5-minute video documentary. After the video, participants will be told whether they are in the "oxytocin" or "control" condition and then self-administer the nasal-spray. Participants will report their expectations through a 11-point-scale (0 for no expected mood enhancement and 10 for large expected mood enhancement, GEEE) as well as mood state using a visual analogue scale (VAS) before the application of the nasal spray, during and after the fMRI measure. In the scanner, they will perform an emotion-interference task. The task is a modified spatial cueing paradigm, established in our lab. Participants will have to respond to left- or right- sided dots that are preceded by a spatially informative cue (arrow pointing to the side where the dot is most likely to appear) or uninformative cue (doubled arrow pointing to both sides). The cues will appear superimposed to a neutral, happy, sad fearful or scrambled face distractors that participant will be told to ignore. Previous studies from our laboratory have demonstrated that without a directional cue, more attentional resources are available to process emotional faces in a goal-directed manner.

The investigators will examine the influence of positive expectations and attention on reaction times and neural processes. Specifically, they hypothesize that older adults will focus more on happy faces and/or less on negative faces compared to neutral faces (i.e. higher/lower reaction times) when more attentional resources are available (attention is not constrained), and that this bias will increase in the positive expectation condition and will be associated with better mood (VAS). Moreover, it is expected that positive expectation effects are related to participants' cognitive control ability. Additionally, the expected positivity and expectation effects will be primarily modulated by the ventromedial prefrontal cortex. This prediction is based on evidence suggesting the preservation of this structure in aging, which compensates for the decline of the dorsolateral prefrontal cortex. Therefore, the investigators predict that positive expectation effects in older adults are related to a shift from the lateral prefrontal cortex to the ventromedial prefrontal cortex.

Being tested
Saline nasal spray
Keywords
Positive expectation, fMRI, Attentional mechanisms, Cognitive control, Aging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Saline nasal sprayOther

    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)

Study groups in NCT06251284
Study groupRoleWhat they receive
Placebo - ControlExperimentalParticipants in this group receive sham oxytocin on the first study day.
Receives: Other: Saline nasal spray
Control - PlaceboExperimentalParticipants in this group receive sham oxytocin on the second study day
Receives: Other: Saline nasal spray

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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.

  2. 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.

    Measured: After the intervention, participants will performed this task during 45 minutes while lying in the scanner on each day.

  3. 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.

    Measured: 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)
  1. Fixation and gaze shifts behaviors (eye-tracking)

    Horizontal gaze trajectories (fixation and gaze shifts patterns) will be recorded using eye-tracking. Data will be extracted and analyzed in degrees of visual angle.

    Measured: Participants fixation patterns will be recorded during the performance of the emotional interference task (for 45 minutes) on each day.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2024
  2. Study start1 Nov 2023
  3. Primary completion1 Jul 2024
  4. Study completion1 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
A cross-over design will be employed by giving a saline nasal spray introduced either as oxytocin or as saline.
Masking
Single blind
Who is masked
Participant
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06251284
Sponsor's protocol ID
PV7141
Status last verified
Dec 2024
First submitted
24 Jan 2024
Last updated
11 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Saline nasal spray in people with Expectation Effects on Emotional Processing in Late Life, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effects of positive expectation on mood (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.

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