Serotonergic Modulation of Cognition, Emotion and Brain Activation in Healthy Volunteers

November 17, 2023 updated by: Professor Barbara Jacquelyn Sahakian, Rigshospitalet, Denmark

The aim of this project is:

  • To apply a pharmacological tool of selective serotonin (5-hydroxytryptamine, 5-HT system) reuptake inhibition in healthy humans. Specifically:
  • To investigate how sub-chronic administration of 20 mg of escitalopram affects cognitive performance ('cold' cognition) and social-emotional functioning ('hot' cognition) compared with placebo; and
  • To investigate how sub-chronic administration of 20 mg of escitalopram affects functional brain activation during a paradigm of reinforcement learning following drug administration compared with placebo, and how activation relates to cognitive performance and social-emotional functioning.

Study Overview

Status

Completed

Conditions

Detailed Description

The aim of this project is:

  • To apply a pharmacological tool of selective serotonin (5-hydroxytryptamine, 5-HT system) reuptake inhibition in healthy humans. Specifically:
  • To investigate how sub-chronic administration of 20 mg of escitalopram affects cognitive performance ('cold' cognition) and social-emotional functioning ('hot' cognition) compared with placebo; and
  • To investigate how sub-chronic administration of 20 mg of escitalopram affects functional brain activation during a paradigm of reinforcement learning following drug administration compared with placebo, and how activation relates to cognitive performance and social-emotional functioning.

Serotonin is a monoamine neurotransmitter implicated in diverse cognitive and affective brain functions. Serotonin has a significant role in the regulation of cognition and mood, including emotional appraisal, perception and flexible behaviour, with 5-HT receptors found in the cortex, amygdala and hippocampus. The investigators have previously shown that in healthy human experimental studies, acute dietary tryptophan depletion induces 'waiting' impulsivity and impulsive behaviours, impairs goal-directed behaviour and shifts behavioural control toward habitual responding when appetitive, but goal-directed when aversive. Reduced availability of forebrain serotonin has also shown to impair a range of cognitive processes, such as psychomotor processing, episodic memory, attention and executive function. Recently, the research team have shown that using an acute and clinically relevant dose (20 mg) of escitalopram impaired learning and cognitive flexibility, but improved response inhibition in healthy humans, suggesting a dissociation of effects possibly mediated by differential modulation of brain serotonin levels in distinct functional neural circuits.

The investigators now aim to investigate the effects of sub-chronic administration of 20 mg of escitalopram (i.e. three weeks) in healthy volunteers using sophisticated neuropsychological testing (Cambridge Neuropsychological Test Automated Battery and EMOTICOM) and functional magnetic resonance imaging (fMRI). Whereas 'cold' cognition refers to the use of non-emotional processing (e.g. episodic memory; spatial working memory), 'hot' cognition is emotion-laden and used in response to stimuli with affective salience (e.g. decision-making under high levels of risk of uncertainty). It has been suggested that cognitive-emotional effects, such as the re-appraisal and re-evaluation of emotions underlying learning mechanisms, may mediate improvements in mood associated with SSRI treatment. This project will help further the understanding of the role of serotonin in the regulation of cognitive and emotional processes, as well the neural correlates underlying reinforcement learning, in healthy humans.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Copenhagen, Denmark, DK-2100
        • Neurobiology Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy volunteer (male or female) between 18 and 45 years.

Exclusion Criteria:

  • Current or former primary psychiatric disorder (DSM IV Axis I or WHO ICD-10 diagnostic classification).
  • Current or previous neurological disease, severe somatic disease, or the consumption of drugs likely to influence the test results.
  • Non- fluent in Danish or pronounced visual or auditory impairments.
  • Current or past learning disability.
  • Pregnancy (females).
  • Lactation (females).
  • Contraindications for MRI (pacemaker, metal implants, etc.).
  • Allergy to the ingredients in the administered drug.
  • Abnormal ECG (e.g. prolonged QT syndrome).
  • Dizzy when changing from supine to upright position (e.g. postural orthostatic tachycardia syndrome).
  • Mild hypotension (blood pressure below 100/70 mmHg) or hypertension (blood pressure above 140/90 mmHg).
  • Head injury or concussion resulting in loss of consciousness for more than 2 min.
  • Alcohol or drug abuse.
  • Drug use other than tobacco and alcohol within the last 30 days.
  • Hash > 50 x lifetime.
  • Drugs > 10 x lifetime (for each substance).
  • Nicotine addiction.
  • Current psychoactive medication.
  • Severe physical impairments affecting eyesight or motor performance.
  • Hamilton-6 depression scale score > 5.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Group
The placebo control group will be administered the exact same procedure as the intervention group, the only difference being that this group will be administered a placebo pill.
Placebo daily for approximately 3 weeks.
Experimental: Intervention Group
The intervention group will be administered 20mg of Escitalopram daily for approximately 3 weeks.
20mg daily for approximately 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Learning Primary Outcome 1: Mean errors Stage 1 (Learning) - Probability Reversal Learning.
Time Frame: 3 years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 years
Learning Primary Outcome 2: Mean errors Stage 2 (Reversal) - Probability Reversal Learning.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Learning Primary Outcome 3: Learning Rate in Reward Trial - Reinforcement Learning.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Learning Primary Outcome 4: Learning Rate in Punishment Trials - Reinforcement Learning.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Inhibition Primary Outcome 1: Stop Signal Reaction Time - Interleaved Stop Signal Task/Go-NoGo.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains.
3 Years
Executive Function Primary Outcome 1: Extra Dimensional Set Errors -3Dimensional Intra/Extra Dimensional Shift.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains.
3 Years
Reinforcement Behaviour Model
Time Frame: 3 Years

A model comparison will be conducted to determine the winning model of reinforcement behaviour using one, a combination of, or all these parameters. The winning model will be a single outcome model.

  1. Reward Learning Rate
  2. Punishment Learning Rate
  3. Reinforcement Sensitivity
  4. Stimulus Stickiness
3 Years
Social Cognition Primary Outcome 1: Proportion of offers accepted - Ultimatum Game
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Social Cognition Primary Outcome 2: Agent Guilt Score - Moral Emotions Task.
Time Frame: 3 Years
3. Agent Shame Score ---------- Moral Emotions Task Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Social Cognition Primary Outcome 3: Agent Shame Score - Moral Emotions Task.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Emotion Recognition Primary Outcome 1: Affective bias in decreasing condition - EMOTICOM Intensity Morphing.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Emotion Recognition Primary Outcome 2: Affective bias for D' - EMOTICOM Emotion Recognition Task.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Emotion Recognition Primary Outcome 3: Detection threshold decreasing - EMOTICOM Intensity Morphing.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Emotion Recognition Primary Outcome 4: D'Prime for Emotion Recognition - EMOTICOM Emotion Recognition Task.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Biofluids: Serum Escitalopram levels
Time Frame: 3 Years
3 Years
PET Imaging: Cerebral (particularly hippocampal) presynaptic density, as measured with 11 C-UCB-J-PET.
Time Frame: 3 Years
Collected in a sub-sample of participants.
3 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Learning Secondary Outcome 1: Stage 1 Reward-Stay/Lose-Shift behaviour - Probability Reversal Learning.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Learning Secondary Outcome 2: Stage 2 Reward-Stay/ Lose-Shift behaviour - Probability Reversal Learning.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Learning Secondary Outcome 3: Pre Extra Dimension Set Errors - 3Dimensional Intra/Extra Dimensional Shift.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Learning Secondary Outcome 4: Proportion of Stays - Sequential Model-Based/Model-Free.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Inhibition Secondary Outcome 1: Go reaction time - Interleaved Stop Signal Task/Go-NoGo.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Inhibition Secondary Outcome 2: Go omission error rate - Interleaved Stop Signal Task/Go-NoGo.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Inhibition Secondary Outcome 3: Go commission error rate - Interleaved Stop Signal Task/Go-NoGo.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Inhibition Secondary Outcome 4: No-Go error rate - Interleaved Stop Signal Task/Go-NoGo.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Executive Function Secondary Outcome 1: Total Errors Adjusted - 3Dimensional Intra/Extra Dimensional Shift.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Executive Function Secondary Outcome 2: Strategy Score - CANTAB Spatial Working Memory.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Social Cognition Secondary Outcome 1: Fairness Sensitivity---------- Ultimatum Game
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains.
3 Years
Emotion Recognition Secondary Outcome 1: Detection threshold increasing - EMOTICOM Intensity Morphing.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Emotion Recognition Secondary Outcome 2: Affective bias in increasing condition - EMOTICOM Intensity Morphing.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Emotion Recognition Secondary Outcome 3: Affective bias for Hit Rate - EMOTICOM Emotion Recognition Task.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Emotion Recognition Secondary Outcome 4: Hit Rate for Emotion Recognition - EMOTICOM Emotion Recognition Task.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Faces and geometric figure discrimination Outcome 1: Accuracy - Faces fMRI paradigm
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Faces and geometric figure discrimination Outcome 2: Response Speed - Faces fMRI paradigm.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Memory Outcome 1: Total Errors Adj - CANTAB Paired Associates Learning
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Memory Outcome 2: First Trial Memory Score - CANTAB Paired Associates Learning.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Memory Outcome 3: Between Search Errors - CANTAB Spatial Working Memory.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Attention Outcome 1: Target Sensitivity (A') - CANTAB Rapid Visual Processing.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Attention Outcome 2: Latency - CANTAB Rapid Visual Processing
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Attention Outcome 3: Probability of False Alarms - CANTAB Rapid Visual Processing
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Risky Decision Making Outcome Outcome 1. Quality of Decision Making - EMOTICOM Cambridge Gamble Task.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Risky Decision Making Outcome 2: Risk Adjustment - EMOTICOM Cambridge Gamble Task
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Risky Decision Making Outcome 3: Overall Proportion Bet - EMOTICOM Cambridge Gamble Task
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Risky Decision Making Outcome 4: Deliberation Time - EMOTICOM Cambridge Gamble Task.
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Psychomotor Speed Outcome 1: Simple reaction time - CANTAB Reaction Time Task
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Psychomotor Speed Outcome 2: Five Choice reaction time - CANTAB Reaction Time Task
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains. FDR correction, for multiple comparisons, using the Benjamin Hochberg procedure will be applied to the outcomes within each cognitive domain.
3 Years
Neural Activations and Correlations - Reinforcement Learning fMRI paradigm
Time Frame: 3 Years
Imaging outcomes will be FWE corrected using Random Field Theory as implemented in SPM12.
3 Years
Neural Activations and Correlations - Faces fMRI paradigm
Time Frame: 3 Years
Imaging outcomes will be FWE corrected using Random Field Theory as implemented in SPM12.
3 Years
Resting State fMRI
Time Frame: 3 Years
Imaging outcomes will be FWE corrected using Random Field Theory as implemented in SPM12.
3 Years
Structural VBM
Time Frame: 3 Years
Imaging outcomes will be FWE corrected using Random Field Theory as implemented in SPM12.
3 Years
Diffusion Tensor Imaging
Time Frame: 3 Years
3 Years
Profile of Mood State Score
Time Frame: 3 Years
3 Years
Beck Depression Inventory-II Score
Time Frame: 3 Years
3 Years
State-Trait Anxiety Inventory Scale -State Score
Time Frame: 3 Years
3 Years
State and Trait Aggression Questionnaire-State Score
Time Frame: 3 Years
3 Years
Baret Impulsivity Scale-State Score
Time Frame: 3 Years
3 Years
Visual Analogue Scale Score
Time Frame: 3 Years
3 Years
Interpersonal Reactivity Index Score
Time Frame: 3 Years
3 Years
Obsessive- Compulsive Inventory Score
Time Frame: 3 Years
3 Years
Brief Symptom Checklist Score
Time Frame: 3 Years
3 Years
Pittsburgh Sleep Quality Index Score
Time Frame: 3 Years
3 Years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotion Recognition Other Outcome 1: Detection threshold decreasing Happy - Intensity Morphing
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains.
3 Years
Emotion Recognition Other Outcome 2: Detection threshold decreasing Sad - Intensity Morphing
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains.
3 Years
Emotion Recognition Other Outcome 3: Detection threshold decreasing Anger - Intensity Morphing
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains.
3 Years
Emotion Recognition Other Outcome 4: Detection threshold decreasing Fear - Intensity Morphing
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains.
3 Years
Emotion Recognition Other Outcome 5: Detection threshold decreasing Disgust - Intensity Morphing
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains.
3 Years
Emotion Recognition Other Outcome 6: D' Happy - Emotion Recognition Task
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains.
3 Years
Emotion Recognition Other Outcome 7: D' Sad - Emotion Recognition Task
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains.
3 Years
Emotion Recognition Other Outcome 8: D' Fear - Emotion Recognition Task
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains.
3 Years
Emotion Recognition Other Outcome 9: D' Anger - Emotion Recognition Task
Time Frame: 3 Years
Outcome variables have been grouped a priori into carefully defined cognitive domains.
3 Years
Activity Level Score
Time Frame: 3 Years
3 Years
Behavioural Inhibition/ Behavioural Avoidance Scale Score
Time Frame: 3 Years
3 Years
The Compulsive Personality Assessment Scale Score
Time Frame: 3 Years
3 Years
Sexuality Questionnaire Score
Time Frame: 3 Years
3 Years
Edinburgh Handedness Inventory Score
Time Frame: 3 Years
3 Years
Revised NEO Personality Questionnaire Score
Time Frame: 3 Years
3 Years
Family History Assessment Module Score
Time Frame: 3 Years
3 Years
Positive Life Events Score
Time Frame: 3 Years
3 Years
Stressful Life Events Score
Time Frame: 3 Years
3 Years
State and Trait Aggression Questionnaire -Trait Score
Time Frame: 3 Years
3 Years
Barret Impulsivity Scale-Trait Score
Time Frame: 3 Years
3 Years
The Penn State Worry Questionnaire- Trait Score
Time Frame: 3 Years
3 Years
The Penn State Worry Questionnaire- State Score
Time Frame: 3 Years
3 Years
The Self-Control Scale- Trait Score
Time Frame: 3 Years
3 Years
The Self-Control Scale- State Score
Time Frame: 3 Years
3 Years
State- Trait Anxiety Inventory- Trait Score
Time Frame: 3 Years
3 Years
The Warwick-Edinburgh Mental Well-being Scale -Trait Score
Time Frame: 3 Years
3 Years
The Warwick-Edinburgh Mental Well-being Scale -State Score
Time Frame: 3 Years
3 Years
Mindful Attention and Awareness Scale -Trait Score
Time Frame: 3 Years
3 Years
Mindful Attention and Awareness Scale -State Score
Time Frame: 3 Years
3 Years
The Intolerance of Uncertainty Scale - Trait Score
Time Frame: 3 Years
3 Years
The Intolerance of Uncertainty Scale - State Score
Time Frame: 3 Years
3 Years
Verran Snyder-Halpern (VSH) Sleep Scale Score
Time Frame: 3 Years
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2020

Primary Completion (Actual)

October 30, 2022

Study Completion (Actual)

October 30, 2022

Study Registration Dates

First Submitted

January 13, 2020

First Submitted That Met QC Criteria

January 22, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon completion of the study all data will be uploaded to the existing CIMBI Database. Researchers may apply for access to the data.

IPD Sharing Time Frame

Upon Compeletion of the Study.

IPD Sharing Access Criteria

Researchers may apply for access to the data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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