PerfectionismNCT05475535
Can a Self-guided Mobile Phone Application Program Improve Wellbeing in University Students
A study testing Cognitive Behavioural Therapy and Self-Compassion in people with Perfectionism and Shame, run by National University of Singapore.
Trial summary
This study seeks to evaluate and compare the effectiveness of a mobile phone application-based intervention in improving wellbeing in young adults. 400 University students are randomized into 1 of 4 intervention types. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Perfectionism, Shame, Depression, Anxiety
- What is being tested?
- Cognitive Behavioural Therapy and Self-Compassion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 30 Nov 2022
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Access to a mobile phone with the following requirements: iPhone 8 and above, or Android 5.2+ (display greater than 5 inches)
- Have scores of greater than or equal to 29 on the 'Concerns over Mistakes' subscale on the FMPS
Who cannot join
- Participants who do not meet the inclusion criteria
- Currently pregnant
- Undergoing psychological treatment or counselling
- Have any change in psychotropic medication within twelve weeks before starting intervention
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Can a Self-guided Cognitive Behavioral-based Mobile Phone Application Program With a Self-Compassion Component Reduce Unhealthy Perfectionism in University Students - a Randomised Controlled Trial (RCT) With a 4-week Follow-up
This study seeks to evaluate and compare the effectiveness of a mobile phone application-based intervention in improving wellbeing in young adults. 400 University students are randomized into 1 of 4 intervention types. Pre, mid and post-intervention outcome measures are compared to determine effectiveness of the various intervention types.
- Conditions
- Perfectionism, Shame, Depression, Anxiety, Stress, Self-Compassion
- Being tested
- Cognitive Behavioural Therapy, Self-Compassion, Active Control
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural TherapyBehavioural
Cognitive Behavioural Therapy
Self-CompassionBehavioural
Self-Compassion focused exercises
Active ControlBehavioural
Engagement in a mobile application (Cooperation skills)
| Study group | Role | What they receive |
|---|---|---|
| Active Control | Active comparator | Not described Receives: Behavioral: Active Control |
| Cognitive Behavioural Therapy (CBT) | Experimental | Not described Receives: Behavioral: Cognitive Behavioural Therapy |
| Self-Compassion (SC) | Experimental | Not described Receives: Behavioral: Self-Compassion |
| Cognitive Behavioural Therapy and Self-Compassion (CBT+SC) | Experimental | Not described Receives: Behavioral: Cognitive Behavioural Therapy; Behavioral: Self-Compassion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maladaptive perfectionism
Frost Multidimensional Perfectionism Scale (FMPS). A 35-item self-report questionnaire which assesses four sub-scales of perfectionism - Concern over mistakes, Excessive concern with parental expectations, Personal Standards and Concern with precision, order and organisation. It is scored on a five-point scale, from "Strongly disagree" (1) to "Strongly agree" (5). Higher scores reflect higher levels of maladaptive perfectionism.
Measured: Day 1, Day 8, Day 14, 4 weeks after completion of treatment
Change in shame
Internalized Shame Scale (ISS). A 30-item self-report questionnaire which assesses internalized shame, and a subscale of self-esteem. It is scored on a five-point scale from "Never" (1) to "Almost always" (5). Higher scores reflect greater symptom severity.
Measured: Day 1, Day 8, Day 14, 4 weeks after completion of treatment
Change in Self-Compassion
Self-Compassion Scale (SCS-SF). A 12-item self-report questionnaire which assesses degree of self-compassion. It is the briefer version of the Self-Compassion Scale (SCS) (Neff, 2003). It is scored on a five-point scale from "Almost never" (1) to "Almost all of the time" (5). A total score is derived from taking the mean of the 12 items. Higher scores reflect greater self- compassion.
Measured: Day 1, Day 8, Day 14, 4 weeks after completion of treatment
Secondary outcomes (3)
Change in Depression
Depression, Anxiety, Stress Scale - 21 (DASS-21). A 21-item self-report questionnaire, which comprises of 3 subscales which assess levels of depression, anxiety and stress. It is scored on a four-point scale, from "Did not apply to me at all" (0) to "Applied to me very much or most of the time" (3). Higher scores reflect greater symptom severity.
Measured: Day 1, Day 8, Day 14, 4 weeks after completion of treatment
Change in Anxiety
Depression, Anxiety, Stress Scale - 21 (DASS-21). A 21-item self-report questionnaire, which comprises of 3 subscales which assess levels of depression, anxiety and stress. It is scored on a four-point scale, from "Did not apply to me at all" (0) to "Applied to me very much or most of the time" (3). Higher scores reflect greater symptom severity.
Measured: Day 1, Day 8, Day 14, 4 weeks after completion of treatment
Change in Stress
Depression, Anxiety, Stress Scale - 21 (DASS-21). A 21-item self-report questionnaire, which comprises of 3 subscales which assess levels of depression, anxiety and stress. It is scored on a four-point scale, from "Did not apply to me at all" (0) to "Applied to me very much or most of the time" (3). Higher scores reflect greater symptom severity.
Measured: Day 1, Day 8, Day 14, 4 weeks after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerfectionismStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tan Pei En Marie, National University of Singapore
- Investigators
- Marie Tan, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475535
- Sponsor's protocol ID
- NUS-IRB-2022-307
- Status last verified
- Jul 2022
- First submitted
- 22 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Self-guided Cognitive Behavioral-based Mobile Phone Application Program With a Self-Compassion Component Reduce Unhealthy Perfectionism in University Students - a Randomised Controlled Trial (RCT) With a 4-week Follow-up
- ClinicalTrials.gov ID
- NCT05475535
- Acronym / sponsor ID
- NUS-IRB-2022-307
- Conditions
- Perfectionism, Shame, Depression, Anxiety, Stress, Self-Compassion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 27 Jul 2022 (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 study seeks to evaluate and compare the effectiveness of a mobile phone application-based intervention in improving wellbeing in young adults. 400 University students are randomized into 1 of 4 intervention types. Pre, mid and post-intervention outcome measures are compared to determine effectiveness of the various intervention types.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Control | Active comparator | Behavioral: Active Control |
| Cognitive Behavioural Therapy (CBT) | Experimental | Behavioral: Cognitive Behavioural Therapy |
| Self-Compassion (SC) | Experimental | Behavioral: Self-Compassion |
| Cognitive Behavioural Therapy and Self-Compassion (CBT+SC) | Experimental | Behavioral: Cognitive Behavioural Therapy, Behavioral: Self-Compassion |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Access to a mobile phone with the following requirements: iPhone 8 and above, or Android 5.2+ (display greater than 5 inches)
- Have scores of greater than or equal to 29 on the 'Concerns over Mistakes' subscale on the FMPS
Key exclusion criteria (4 listed)
- Participants who do not meet the inclusion criteria
- Currently pregnant
- Undergoing psychological treatment or counselling
- Have any change in psychotropic medication within twelve weeks before starting intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural TherapyCognitive Behavioural Therapy | Behavioural | Cognitive Behavioural Therapy (CBT), Cognitive Behavioural Therapy and Self-Compassion (CBT+SC) |
| Self-CompassionSelf-Compassion focused exercises | Behavioural | Cognitive Behavioural Therapy and Self-Compassion (CBT+SC), Self-Compassion (SC) |
| Active ControlEngagement in a mobile application (Cooperation skills) | Behavioural | Active Control |
Primary outcome
Change in maladaptive perfectionism
Time frame: Day 1, Day 8, Day 14, 4 weeks after completion of treatment
Frost Multidimensional Perfectionism Scale (FMPS). A 35-item self-report questionnaire which assesses four sub-scales of perfectionism - Concern over mistakes, Excessive concern with parental expectations, Personal Standards and Concern with precision, order and organisation. It is scored on a five-point scale, from "Strongly disagree" (1) to "Strongly agree" (5). Higher scores reflect higher levels of maladaptive perfectionism.
Change in shame
Time frame: Day 1, Day 8, Day 14, 4 weeks after completion of treatment
Internalized Shame Scale (ISS). A 30-item self-report questionnaire which assesses internalized shame, and a subscale of self-esteem. It is scored on a five-point scale from "Never" (1) to "Almost always" (5). Higher scores reflect greater symptom severity.
Change in Self-Compassion
Time frame: Day 1, Day 8, Day 14, 4 weeks after completion of treatment
Self-Compassion Scale (SCS-SF). A 12-item self-report questionnaire which assesses degree of self-compassion. It is the briefer version of the Self-Compassion Scale (SCS) (Neff, 2003). It is scored on a five-point scale from "Almost never" (1) to "Almost all of the time" (5). A total score is derived from taking the mean of the 12 items. Higher scores reflect greater self- compassion.
3 secondary outcomes
Change in Depression
Time frame: Day 1, Day 8, Day 14, 4 weeks after completion of treatment
Change in Anxiety
Time frame: Day 1, Day 8, Day 14, 4 weeks after completion of treatment
Change in Stress
Time frame: Day 1, Day 8, Day 14, 4 weeks after completion of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Marie Tan principal investigator
National University of Singapore
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy and Self-Compassion in people with Perfectionism and Shame, run by National University of Singapore.
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 2 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: status not confirmed, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Tan (85180328, e0788233@u.nus.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maladaptive perfectionism (time frame: Day 1, Day 8, Day 14, 4 weeks after completion of treatment). 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 2 Aug 2022.