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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05475535
Other study ID # NUS-IRB-2022-307
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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