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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress; Depression, Anxiety; Perfectionism; Shame; Self-Compassion
• Intervention / Treatment: Behavioral: Active Control; Behavioral: Cognitive Behavioural Therapy; Behavioral: Self-Compassion

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie Tan; Phone Number: 85180328; Email: e0788233@u.nus.edu
• Study Contact Backup: Name: Mark Ngoh; Phone Number: 90125077; Email: mark.ngoh@u.nus.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Control	Behavioral: Active Control; Engagement in a mobile application (Cooperation skills)
Experimental: Cognitive Behavioural Therapy (CBT)	Behavioral: Cognitive Behavioural Therapy; Cognitive Behavioural Therapy
Experimental: Self-Compassion (SC)	Behavioral: Self-Compassion; Self-Compassion focused exercises
Experimental: Cognitive Behavioural Therapy and Self-Compassion (CBT+SC)	Behavioral: Cognitive Behavioural Therapy; Cognitive Behavioural Therapy; Behavioral: Self-Compassion; Self-Compassion focused exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: National University, Singapore
• Investigators: Principal Investigator: Marie Tan, National University, Singapore

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): November 30, 2022
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: July 22, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: NUS-IRB-2022-307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No