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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Behavioral: Cognitive Behavioural Therapy
* Behavioral: Self-Compassion
* Behavioral: Active Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |