Effectiveness of a Self-guided Mobile Application in Improving Obsessive Compulsive Disorder Symptoms

Not Applicable

Active, not recruiting

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Device: Self-guided program on cooperation; Device: Self-guided program on obsessive compulsive disorder

• Registration Number: NCT06202677
• Lead Sponsor: National University of Singapore

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.

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-01-01
• Study First Submitted QC: 2024-01-01
• Study First Posted: 2024-01-11
• Primary Completion: 2024-03-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-07-01
• Study Completion: 2024-07-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 225

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Control group	Self-guided program on cooperation	Participants will complete an 8-day self-guided programme on cooperation delivered via a mobile phone application with daily exercises that differ from the intervention group in terms of content but are comparable in terms of duration.
Experimental: Intervention group: Obsessive Compulsive Disorder Program	Self-guided program on obsessive compulsive disorder	Participants will complete an 8-day self-guided programme on obsessive compulsive disorder delivered via a mobile phone application with daily exercises guided by cognitive-behavioural and exposure and response prevention principles.

Primary Outcome Measures

Name	Time	Method
Change of obsessive compulsive disorder symptoms	Baseline, 8 days (completion of intervention), 4 weeks (follow-up)	The Obsessive Compulsive Inventory - Revised (OCI-R; Foa et al., 2002) is used. The OCI-R is an 18-item self-report questionnaire which assesses OCD symptoms across 6 subscales: washing, checking, neutralising, obsessing, ordering, and hoarding. Each item is rated on a 5-point Likert scale with scores ranging from Not at all (0) to Extremely (4). The total score (ranging from 0-72) is the sum of all the items.

Secondary Outcome Measures

Name	Time	Method
Change of depression, anxiety and stress symptoms	Baseline, 8 days (completion of intervention), 4 weeks (follow-up)	The Depression Anxiety Stress Scale-21 (DASS-21; Lovibond and Lovibond, 1995) is a set of three self-report scales assessing depression, anxiety and stress. Each subscale contains 7 items, totalling 21 items which are each rated on a 4-point Likert scale ranging from Did not apply to me at all (0) to Applied to me very much or most of the time (3). Three subscale scores and a total score can be computed by summing the items in each subscale.

Trial Locations

Locations (1)

National University of Singapore; 🇸🇬 Singapore, Singapore