Can a Self-guided Mobile Phone Application Program Improve Wellbeing in University Students

Stress Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05475535
• Other study ID #: NUS-IRB-2022-307
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: July 2022
• Source: National University, Singapore
• Contact: Marie Tan
• Phone: 85180328
• Email: e0788233[@]u.nus.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Pre, mid and post-intervention outcome measures are compared to determine effectiveness of the various intervention types.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety
• Perfectionism
• Self-Compassion
• Shame
• Stress

Intervention

Behavioral:
• Cognitive Behavioural Therapy
Cognitive Behavioural Therapy
• Self-Compassion
Self-Compassion focused exercises
• Active Control
Engagement in a mobile application (Cooperation skills)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National University, Singapore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1, Day 8, Day 14, 4 weeks after completion of treatment
Primary	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.	Day 1, Day 8, Day 14, 4 weeks after completion of treatment
Primary	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.	Day 1, Day 8, Day 14, 4 weeks after completion of treatment
Secondary	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.	Day 1, Day 8, Day 14, 4 weeks after completion of treatment
Secondary	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.	Day 1, Day 8, Day 14, 4 weeks after completion of treatment
Secondary	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.	Day 1, Day 8, Day 14, 4 weeks after completion of treatment