NCT03698175

Brief Summary

The aim of this study is to explore whether a brief mental exercise (developed and widely advocated in the field of positive psychology) can change the processing of emotion-related information in a similar way as previously observed for antidepressant drugs. Healthy volunteers are randomly allocated to a 7-day practice of the "Three Good Things" (TGT) exercise or a previously used placebo exercise (unspecified childhood memory recall) with study participants as well as investigators being blind as to which practice is conducted. After a 7-day practice period, all study participants undergo testing with the Oxford Emotional Test Battery, an established battery of cognitive tasks that allow to assess how emotional information is processed. The working hypothesis of the study is that the TGT exercise, as compared to the placebo exercise, can push the processing of emotional information towards a prioritisation of positive (relative to negative) input.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

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

May 24, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2018

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2018

Completed
Last Updated

April 18, 2019

Status Verified

September 1, 2018

Enrollment Period

1.4 years

First QC Date

October 4, 2018

Last Update Submit

April 17, 2019

Conditions

Keywords

EmotionCognitionPositive psychology

Outcome Measures

Primary Outcomes (1)

  • Performance in a facial expression recognition task

    Participants are presented with individual pictures of facial expressions of emotions. Each presented face displays one of six basic emotions (anger, disgust, fear, happiness, sadness, or surprise). Each emotional expression is presented at different levels of intensity which have been created by combining shape and texture features of the two extremes "neutral" (0%) and "full prototypical emotion" (100%) to varying degrees. Examples of neutral facial expressions are presented as well. Participants are instructed to correctly classify each facial expression as angry, disgusted, fearful, happy, sad, surprised or neutral both as quickly and as accurately as possible. Responses are made by pushing one out of seven labelled keys on a response box. Hit rates, false alarm rates, and reaction times for correct classifications are measured separately for each emotion.

    Completed at day 8 after exercise has been started

Secondary Outcomes (5)

  • Performance in an emotional categorisation task

    Completed at day 8 after exercise has been started

  • Performance in an emotional faces dot probe task

    Completed at day 8 after exercise has been started

  • Performance in an emotional recall task

    Completed at day 8 after exercise has been started

  • Performance in an emotional recognition task

    Completed at day 8 after exercise has been started

  • Change in cortisol awakening response

    Completed at day 8 after exercise has been started

Other Outcomes (8)

  • Change in subclinical depressive symptoms

    Completed at day 8 after exercise has been started

  • Change in authentic happiness

    Completed at day 8 after exercise has been started

  • Change in subjective anxiety

    Completed at day 8 after exercise has been started

  • +5 more other outcomes

Study Arms (2)

Three good things exercise

EXPERIMENTAL
Behavioral: Three good things exercise

Unspecific childhood memory recall exercise

PLACEBO COMPARATOR
Behavioral: Placebo exercise

Interventions

Participants are asked to remember each evening three things that went well during their day and to write them down in a journal including a short explanation of why they think each of them has happened.

Three good things exercise

Participants are asked to briefly recall a childhood memory (no further specification) and to write it down including a short explanation why they think it has happened.

Unspecific childhood memory recall exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female or male
  • Age: 18 to 65 years
  • Good general health
  • Competency to give informed consent

You may not qualify if:

  • Any current or past psychiatric disorder
  • Any first-degree relative with a diagnosis of schizophrenia-spectrum or other psychotic disorder, bipolar disorder, or depressive disorder
  • Regular engagement in mental exercises specifically aimed at improving cognitive abilities (concentration, attention, memory etc.), mood, or general well-being, such as (online) cognitive training, positive psychology exercises, regular meditation or mindfulness practices, yoga practices, or psychotherapeutic exercises.
  • Regular engagement in any of the exercises outlined above within the last 6 months.
  • Any severe medical condition not stabilized at the time of the study (e.g. asthma, heart disease, epilepsy)
  • Any current or past physical illness that has the potential to significantly affect mental functioning (e.g. stroke, Parkinson's disease, multiple sclerosis)
  • Current intake of medication that has a significant potential to affect mental functioning, or intake of such medication in the previous 3 months (e.g. antidepressants, neuroleptics, tranquilizers)
  • Any intake of recreational drugs in the last 3 months before the experiment
  • Regular consumption of higher doses of alcohol (more than 2 pints of beer or equivalent on more than 3 days a week within the last month)
  • Any other reasons that preclude participants from full participation in the experiment (e.g. insufficient knowledge of English language)
  • Any other condition which can make participation in the study harmful for a participant, or which can severely compromise the quality of the data (e.g. low intellectual functioning)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oxford

Oxford, OX3 7JZ, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2018

First Posted

October 5, 2018

Study Start

May 24, 2017

Primary Completion

October 10, 2018

Study Completion

October 10, 2018

Last Updated

April 18, 2019

Record last verified: 2018-09

Locations