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

Sponsor
National University, Singapore (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05475535
Collaborator
(none)
400
4
4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Behavioural Therapy
  • Behavioral: Self-Compassion
  • Behavioral: Active Control
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in maladaptive perfectionism [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.

  2. Change in shame [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.

  3. Change in Self-Compassion [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.

Secondary Outcome Measures

  1. Change in Depression [Day 1, Day 8, Day 14, 4 weeks after completion of treatment]

    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.

  2. Change in Anxiety [Day 1, Day 8, Day 14, 4 weeks after completion of treatment]

    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.

  3. Change in Stress [Day 1, Day 8, Day 14, 4 weeks after completion of treatment]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • National University, Singapore

Investigators

  • Principal Investigator: Marie Tan, National University, Singapore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tan Pei En Marie, Principal Investigator, National University, Singapore
ClinicalTrials.gov Identifier:
NCT05475535
Other Study ID Numbers:
  • NUS-IRB-2022-307
First Posted:
Jul 27, 2022
Last Update Posted:
Aug 2, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2022