Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT05475535
Status:
UNKNOWN
Last Update Posted:
2022-08-02
First Post:
2022-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Can a Self-guided Mobile Phone Application Program Improve Wellbeing in University Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-29', 'studyFirstSubmitDate': '2022-07-22', 'studyFirstSubmitQcDate': '2022-07-26', 'lastUpdatePostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in maladaptive perfectionism', 'timeFrame': 'Day 1, Day 8, Day 14, 4 weeks after completion of treatment', 'description': '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.'}, {'measure': 'Change in shame', 'timeFrame': 'Day 1, Day 8, Day 14, 4 weeks after completion of treatment', 'description': '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.'}, {'measure': 'Change in Self-Compassion', 'timeFrame': 'Day 1, Day 8, Day 14, 4 weeks after completion of treatment', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Depression', 'timeFrame': 'Day 1, Day 8, Day 14, 4 weeks after completion of treatment', 'description': '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.'}, {'measure': 'Change in Anxiety', 'timeFrame': 'Day 1, Day 8, Day 14, 4 weeks after completion of treatment', 'description': '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.'}, {'measure': 'Change in Stress', 'timeFrame': 'Day 1, Day 8, Day 14, 4 weeks after completion of treatment', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perfectionism', 'Shame', 'Depression, Anxiety', 'Stress', 'Self-Compassion']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Access to a mobile phone with the following requirements: iPhone 8 and above, or Android 5.2+ (display greater than 5 inches)\n* Have scores of greater than or equal to 29 on the 'Concerns over Mistakes' subscale on the FMPS\n\nExclusion Criteria:\n\n* Participants who do not meet the inclusion criteria\n* Currently pregnant\n* Undergoing psychological treatment or counselling\n* Have any change in psychotropic medication within twelve weeks before starting intervention"}, 'identificationModule': {'nctId': 'NCT05475535', 'briefTitle': 'Can a Self-guided Mobile Phone Application Program Improve Wellbeing in University Students', 'organization': {'class': 'OTHER', 'fullName': 'National University of Singapore'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NUS-IRB-2022-307'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Control', 'interventionNames': ['Behavioral: Active Control']}, {'type': 'EXPERIMENTAL', 'label': 'Cognitive Behavioural Therapy (CBT)', 'interventionNames': ['Behavioral: Cognitive Behavioural Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Self-Compassion (SC)', 'interventionNames': ['Behavioral: Self-Compassion']}, {'type': 'EXPERIMENTAL', 'label': 'Cognitive Behavioural Therapy and Self-Compassion (CBT+SC)', 'interventionNames': ['Behavioral: Cognitive Behavioural Therapy', 'Behavioral: Self-Compassion']}], 'interventions': [{'name': 'Cognitive Behavioural Therapy', 'type': 'BEHAVIORAL', 'description': 'Cognitive Behavioural Therapy', 'armGroupLabels': ['Cognitive Behavioural Therapy (CBT)', 'Cognitive Behavioural Therapy and Self-Compassion (CBT+SC)']}, {'name': 'Self-Compassion', 'type': 'BEHAVIORAL', 'description': 'Self-Compassion focused exercises', 'armGroupLabels': ['Cognitive Behavioural Therapy and Self-Compassion (CBT+SC)', 'Self-Compassion (SC)']}, {'name': 'Active Control', 'type': 'BEHAVIORAL', 'description': 'Engagement in a mobile application (Cooperation skills)', 'armGroupLabels': ['Active Control']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marie Tan', 'role': 'CONTACT', 'email': 'e0788233@u.nus.edu', 'phone': '85180328'}, {'name': 'Mark Ngoh', 'role': 'CONTACT', 'email': 'mark.ngoh@u.nus.edu', 'phone': '90125077'}], 'overallOfficials': [{'name': 'Marie Tan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University of Singapore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University of Singapore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tan Pei En Marie', 'investigatorAffiliation': 'National University of Singapore'}}}}