NCT05475535

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

August 2, 2022

Status Verified

July 1, 2022

Enrollment Period

4 months

First QC Date

July 22, 2022

Last Update Submit

July 29, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Change in Depression

    Day 1, Day 8, Day 14, 4 weeks after completion of treatment

  • Change in Anxiety

    Day 1, Day 8, Day 14, 4 weeks after completion of treatment

  • Change in Stress

    Day 1, Day 8, Day 14, 4 weeks after completion of treatment

Study Arms (4)

Active Control

ACTIVE COMPARATOR
Behavioral: Active Control

Cognitive Behavioural Therapy (CBT)

EXPERIMENTAL
Behavioral: Cognitive Behavioural Therapy

Self-Compassion (SC)

EXPERIMENTAL
Behavioral: Self-Compassion

Cognitive Behavioural Therapy and Self-Compassion (CBT+SC)

EXPERIMENTAL
Behavioral: Cognitive Behavioural TherapyBehavioral: Self-Compassion

Interventions

Cognitive Behavioural Therapy

Cognitive Behavioural Therapy (CBT)Cognitive Behavioural Therapy and Self-Compassion (CBT+SC)
Self-CompassionBEHAVIORAL

Self-Compassion focused exercises

Cognitive Behavioural Therapy and Self-Compassion (CBT+SC)Self-Compassion (SC)
Active ControlBEHAVIORAL

Engagement in a mobile application (Cooperation skills)

Active Control

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Currently pregnant
  • Undergoing psychological treatment or counselling
  • Have any change in psychotropic medication within twelve weeks before starting intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Marie Tan

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 22, 2022

First Posted

July 27, 2022

Study Start

August 1, 2022

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

August 2, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share