Back to resultsCan a Self-guided Mobile Phone Application Program Improve Wellbeing in University Students
Primary Purpose
Perfectionism, Shame, Depression, Anxiety
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy
Self-Compassion
Active Control
Sponsored by
About this trial
This is an interventional treatment trial for Perfectionism
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Active Control
Cognitive Behavioural Therapy (CBT)
Self-Compassion (SC)
Cognitive Behavioural Therapy and Self-Compassion (CBT+SC)
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05475535
First Posted
July 22, 2022
Last Updated
July 29, 2022
Sponsor
National University of Singapore
1. Study Identification
Unique Protocol Identification Number
NCT05475535
Brief Title
Can a Self-guided Mobile Phone Application Program Improve Wellbeing in University Students
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. Pre, mid and post-intervention outcome measures are compared to determine effectiveness of the various intervention types.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perfectionism, Shame, Depression, Anxiety, Stress, Self-Compassion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Control
Arm Type
Active Comparator
Arm Title
Cognitive Behavioural Therapy (CBT)
Arm Type
Experimental
Arm Title
Self-Compassion (SC)
Arm Type
Experimental
Arm Title
Cognitive Behavioural Therapy and Self-Compassion (CBT+SC)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy
Intervention Description
Cognitive Behavioural Therapy
Intervention Type
Behavioral
Intervention Name(s)
Self-Compassion
Intervention Description
Self-Compassion focused exercises
Intervention Type
Behavioral
Intervention Name(s)
Active Control
Intervention Description
Engagement in a mobile application (Cooperation skills)
Primary Outcome Measure Information:
Title
Change in maladaptive perfectionism
Description
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.
Time Frame
Day 1, Day 8, Day 14, 4 weeks after completion of treatment
Title
Change in shame
Description
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.
Time Frame
Day 1, Day 8, Day 14, 4 weeks after completion of treatment
Title
Change in Self-Compassion
Description
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.
Time Frame
Day 1, Day 8, Day 14, 4 weeks after completion of treatment
Secondary Outcome Measure Information:
Title
Change in Depression
Description
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.
Time Frame
Day 1, Day 8, Day 14, 4 weeks after completion of treatment
Title
Change in Anxiety
Description
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.
Time Frame
Day 1, Day 8, Day 14, 4 weeks after completion of treatment
Title
Change in Stress
Description
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.
Time Frame
Day 1, Day 8, Day 14, 4 weeks after completion of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Tan
Phone
85180328
Email
e0788233@u.nus.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Ngoh
Phone
90125077
Email
mark.ngoh@u.nus.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Tan
Organizational Affiliation
National University of Singapore
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Can a Self-guided Mobile Phone Application Program Improve Wellbeing in University Students
We'll reach out to this number within 24 hrs