General Population, no Specific ConditionNCT04238325
Spanish Validation Frustration Discomfort Scale
An observational study of General Population, no Specific Condition, run by Universitat Jaume I at 1 site in Spain.
Trial summary
This is an observational study aimed at validating the Frustration Discomfort Scale (Harrington, 2005). A back-translation process was followed to obtain a translated version of the scale, which was refined after a discussion with several clinicians. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- General Population, no Specific Condition
- How many people
- 1,513 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2020to 30 May 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This protocol will be disseminated globally to the population in Spain with no restriction. The maximum efforts will be made to disseminate the study to a wide range of individuals
Who may be able to join
- Being over 18 years of age
- Signs the informed consent
- Can read and understand Spanish
- Has access to a computer, a tablet or a smartphone with an internet connection
Who cannot join
- Being younger than 18 years of age
- Does not sign the informed consent
- Cannot read or understand Spanish
- Does not have access to a computer, a tablet or a smartphone with an internet connection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spanish Validation of the Frustration Discomfort Scale
This is an observational study aimed at validating the Frustration Discomfort Scale (Harrington, 2005). A back-translation process was followed to obtain a translated version of the scale, which was refined after a discussion with several clinicians.
Read the detailed description
In the study, the Spanish adaptation of the Frustration Discomfort Scale will be disseminated with an online questionnaire using the Qualtrics platform. Additional questionnaires to explore the validity of the adapted scale will also be administered. Participants who complete the questionnaires and provide a valid ID number will enter a participate in a raffle to win an Amazon coupon of 40 euros. Ten coupons will be offered in total amongst participants.
What is being measured
The primary outcome is the main question the study is designed to answer.
Frustration Discomfort Scale
This is a measure of frustration intolerance. The original English version has been translated using a back-translation method and discussions about item have been made with clinicians with expertise in the field. The scale has 28 items that are gouped in 4 subscales. Items have a 1-to-5 response scale ranging from "nothing" to "a lot"
Measured: The measure will be administered 1 day once only together with the remaining measures
Secondary outcomes (10)
Rosenberg self-esteem scale
This scale of self-esteem has 10 items with responses ranging from 1 (completely agree) to 4 (completely disagree). This measure will be used for concurrent criterion validity analyses
Measured: The measure will be administered 1 day once only together with the remaining measures
Satisfaction with life scale
This 5-item scale measures an individual's satisfaction with life using response options ranging from 1 (completely disagree) to 5 (completely agree). This measure will be used for concurrent criterion validity analyses
Measured: The measure will be administered 1 day once only together with the remaining measures
Acceptance and action questionnaire - II
This 7-item scale measures acceptance of difficult experiences using a 7-point response scale (1= never true; 7=always true). This measure will be used for construct validity analyses
Measured: The measure will be administered 1 day once only together with the remaining measures
STAXI - 2 (trait anger scale only)
The trait anger scale of the STAXI-2, which has 10 items, will be used to evaluate trait anger. The responses in the scale range from 1="not at all" to 4="very much". This measure will be used for concurrent criterion validity analyses
Measured: The measure will be administered 1 day once only together with the remaining measures
Irrational Procrastination Scale
This 9-item scale will be administered to measure perceived procrastination. Items in the scale have a 5-point range (1=does not describe me at all; 5=decribes me completely). This measure will be used for concurrent criterion validity analyses
Measured: The measure will be administered 1 day once only together with the remaining measures
Trait Injustice Experiences Questionnare
This measure of perceived trait injustice beliefs has 12 items, with responses ranging from 0="never" to 4="always". This measure will be used for construct validity analyses
Measured: The measure will be administered 1 day once only together with the remaining measures
European version of the Perceived Stress Scale
This 10-item measure of perceived stress will be used for concurrent criterion validity analyses. Responses in the scale range from 0="never" to 4="very frequently"
Measured: The measure will be administered 1 day once only together with the remaining measures
Patient Health Questionnaire
This 10-item measure of depressive symptoms will be used for concurrent criterion validity analyses. Response scales range from 0="None of the days" to 3="Almost all days"
Measured: The measure will be administered 1 day once only together with the remaining measures
General Anxiety Disorder scale
This 7-item measure of anxiety symptoms will be used for concurrent criterion validity analyses. Response scales range from 0="None of the days" to 3="Almost all days"
Measured: The measure will be administered 1 day once only together with the remaining measures
General Attitudes and Beliefs Scale - reduced
A shortened, 12-item version of the General Attitudes and Beliefs Scale will be administered. This measure will be used for concurrent criterion validity analyses. Responses in the scale have a 1-5 range (1="completely disagree"; 5="completely agree")
Measured: The measure will be administered 1 day once only together with the remaining measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start10 Jan 2020
- Primary completion30 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Population, no Specific ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,513 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Zaragoza, University of Seville, Universidad Rey Juan Carlos
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238325
- Sponsor's protocol ID
- FrustrationUJI
- Status last verified
- May 2020
- First submitted
- 20 Jan 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the main PI will have access to the data.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish Validation of the Frustration Discomfort Scale
- ClinicalTrials.gov ID
- NCT04238325
- Acronym / sponsor ID
- FrustrationUJI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,513 participants (actual)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Collaborators
- Universidad de Zaragoza, University of Seville, Universidad Rey Juan Carlos
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study aimed at validating the Frustration Discomfort Scale (Harrington, 2005). A back-translation process was followed to obtain a translated version of the scale, which was refined after a discussion with several clinicians.
Detailed description
In the study, the Spanish adaptation of the Frustration Discomfort Scale will be disseminated with an online questionnaire using the Qualtrics platform. Additional questionnaires to explore the validity of the adapted scale will also be administered. Participants who complete the questionnaires and provide a valid ID number will enter a participate in a raffle to win an Amazon coupon of 40 euros. Ten coupons will be offered in total amongst participants.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This protocol will be disseminated globally to the population in Spain with no restriction. The maximum efforts will be made to disseminate the study to a wide range of individuals
Key inclusion criteria (4 listed)
- Being over 18 years of age
- Signs the informed consent
- Can read and understand Spanish
- Has access to a computer, a tablet or a smartphone with an internet connection
Key exclusion criteria (4 listed)
- Being younger than 18 years of age
- Does not sign the informed consent
- Cannot read or understand Spanish
- Does not have access to a computer, a tablet or a smartphone with an internet connection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frustration Discomfort Scale
Time frame: The measure will be administered 1 day once only together with the remaining measures
This is a measure of frustration intolerance. The original English version has been translated using a back-translation method and discussions about item have been made with clinicians with expertise in the field. The scale has 28 items that are gouped in 4 subscales. Items have a 1-to-5 response scale ranging from "nothing" to "a lot"
10 secondary outcomes
Rosenberg self-esteem scale
Time frame: The measure will be administered 1 day once only together with the remaining measures
Satisfaction with life scale
Time frame: The measure will be administered 1 day once only together with the remaining measures
Acceptance and action questionnaire - II
Time frame: The measure will be administered 1 day once only together with the remaining measures
STAXI - 2 (trait anger scale only)
Time frame: The measure will be administered 1 day once only together with the remaining measures
Irrational Procrastination Scale
Time frame: The measure will be administered 1 day once only together with the remaining measures
Trait Injustice Experiences Questionnare
Time frame: The measure will be administered 1 day once only together with the remaining measures
European version of the Perceived Stress Scale
Time frame: The measure will be administered 1 day once only together with the remaining measures
Patient Health Questionnaire
Time frame: The measure will be administered 1 day once only together with the remaining measures
General Anxiety Disorder scale
Time frame: The measure will be administered 1 day once only together with the remaining measures
General Attitudes and Beliefs Scale - reduced
Time frame: The measure will be administered 1 day once only together with the remaining measures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Individual participant dataSharing planned: No. Only the main PI will have access to the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Population, no Specific Condition, run by Universitat Jaume I at 1 site in Spain.
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 18 Jun 2020. 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 Spain. 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?
Frustration Discomfort Scale (time frame: The measure will be administered 1 day once only together with the remaining measures). 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 18 Jun 2020.