Clinical trial NCT06202677: Effectiveness of a Self-guided Mobile Application in Improving Obsessive Compulsive Disorder Symptoms
Official title: Effectiveness of a Self-guided Mobile Application in Improving Obsessive Compulsive Disorder Symptoms in Young Adults With Subclinical OCD - A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: Intellect Pte. Ltd.
First posted: 2024-01-11
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Obsessive Compulsive Disorder (OCD) is a significant mental health problem worldwide. OCD typically begins in young adulthood, and without adequate intervention, often takes a chronic course. Individuals with OCD may suffer impaired relationships, and ability to engage in leisure activities, study or work. Thus, prevention efforts are crucial to target OCD symptoms before they worsen.

The goal of this randomized-controlled trial (RCT) is to evaluate the effectiveness of a self-guided OCD program on a mobile phone application in young adults with subclinical OCD symptoms.

Hypothesis 1a: The intervention group will report significantly lower OCD symptoms (primary measure) at post-intervention and 1-month follow-up compared to the control group.

Hypothesis 1b. The intervention group will report significantly lower depression, anxiety and stress symptoms (secondary measure) at post-intervention and 1-month follow-up compared to the control group.

Hypothesis 2. Perfectionism will moderate the expected relationship between the OCD intervention and the reduction of scores on both primary and secondary measures, i.e. individuals with lower levels of perfectionism will benefit more from the OCD intervention than those with higher levels of perfectionism.

Detailed description: Procedure:

Interested individuals will sign up for the study via an online survey link on the university's recruitment sites. They will first complete a pre-screening questionnaire on Qualtrics and be assessed on their eligibility based on the inclusion criteria (able to read and understand English, being a student from the National University of Singapore aged 18 to 30, and presenting with moderate subclinical OCD). Eligible participants read the Participation Information Sheet, and after providing informed consent, complete measures on depression, stress, anxiety, and perfectionism. They will also provide their demographic information (age, gender).

Next, participants are randomized to either the intervention or active control condition using simple randomization procedures and guided to download the mobile application on their mobile phone. Participants in the intervention group will undergo 8 days of the OCD learning program, while participants in the active waitlist control group will undergo 8 days of the cooperation learning program. Participation in each program is estimated to be about five minutes per day.

Upon completion of the 8-day program, participants will receive a survey link to complete measures on OCD, depression, anxiety, stress, and the App Engagement Scale. One month upon completion of the 8-day program, participants will be sent a survey link to the same survey, without the App Engagement Scale. They will also be briefed with an information sheet explaining the main purposes of the study. All participants will be given access to all well-being programs available on the app at the end of the study for their personal use. They will be reimbursed with either course credits or a small monetary fee for their participation in the study. Participants who chose to volunteer their participation will not be reimbursed.

Data screening:

Ineligible individuals, incomplete responses, long strings of identical responses, and outliers with data 3 standard deviations from the mean will be excluded from data analyses. Submissions with an overall response time of below 660s will be flagged.

Preliminary Analyses Statistical analyses will be done using SPSS Version 26.0. First, data will be visually inspected using scatterplots and histograms to examine the distribution of data and identify significant outliers. Analyses will be conducted with and without outliers to determine if outliers impact the results significantly. If results are significantly impacted by outliers, they will be will be replaced with the next closest non-outlying data point.

Data will be screened for normality and compliance with statistical assumptions. Independent t-tests and chi-square tests will examine the differences between the 2 conditions on all demographic and dependent variables.

Intent-to-treat analyses will be conducted to address missing data on questionnaires, by carrying forward the participants' last reported score. Missing data on the AES were accounted for using mean substitution.

Main analyses:

Assumptions for ANCOVA will first be conducted. For outcome measures where assumptions were violated, one-way ANOVA using difference scores. Thereafter, ANCOVA will be conducted to determine if changes in outcome measures at post-intervention and follow-up were significantly different between the two conditions. Baseline scores of the relevant outcome measure will be used as the covariate.

Moderation analyses:

Hayes PROCESS macro version 4.6 Model 1 will be used to conduct regression analysis between perfectionism and both primary and secondary measures. Confidence intervals will be set at 95% and bootstrapping samples = 5000.

Eligibility criteria: Inclusion Criteria:

* Age 18-30 mild, subclinical OCD (OCI-R score of 0 to 20) Good command of the English language Owns a mobile phone for downloading the mobile application for use in the study's intervention Singaporean or Permanent Resident of Singapore

Exclusion Criteria:

* None

Primary outcomes:
measure: Change of obsessive compulsive disorder symptoms
timeFrame: Baseline, 8 days (completion of intervention), 4 weeks (follow-up)
Secondary outcomes:
measure: Change of depression, anxiety and stress symptoms
timeFrame: Baseline, 8 days (completion of intervention), 4 weeks (follow-up)
Other outcomes:
measure: Perfectionism
timeFrame: Baseline
measure: Engagement with the mobile application
timeFrame: 8 days (completion of intervention)
Locations:
city: Singapore
country: Singapore
facility: National University of Singapore
Study officials:
affiliation: National University of Singapore
name: Stephanie Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bakker D, Rickard N. Engagement in mobile phone app for self-monitoring of emotional wellbeing predicts changes in mental health: MoodPrism. J Affect Disord. 2018 Feb;227:432-442. doi: 10.1016/j.jad.2017.11.016. Epub 2017 Nov 9.
citation: Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
citation: Foa EB, Huppert JD, Leiberg S, Langner R, Kichic R, Hajcak G, Salkovskis PM. The Obsessive-Compulsive Inventory: development and validation of a short version. Psychol Assess. 2002 Dec;14(4):485-96.
citation: Frost, R. O., Marten, P., Lahart, C., & Rosenblate, R. The dimensions of perfectionism. Cognitive Therapy and Research. 1990; 14(5): 449-468.