NCT06202677

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.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2024

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

January 1, 2024

Last Update Submit

June 27, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change of obsessive compulsive disorder symptoms

    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.

    Baseline, 8 days (completion of intervention), 4 weeks (follow-up)

Secondary Outcomes (1)

  • Change of depression, anxiety and stress symptoms

    Baseline, 8 days (completion of intervention), 4 weeks (follow-up)

Other Outcomes (2)

  • Perfectionism

    Baseline

  • Engagement with the mobile application

    8 days (completion of intervention)

Study Arms (2)

Experimental: Intervention group: Obsessive Compulsive Disorder Program

EXPERIMENTAL

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.

Device: Self-guided program on obsessive compulsive disorder

Control group

ACTIVE COMPARATOR

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.

Device: Self-guided program on cooperation

Interventions

This is an 8-day program that provides psychoeducational on what obsessions and compulsions are, and how to identify them. Subsequently, through a series of content learning and daily exercises that increase in difficulty, participants are guided to conduct exposure exercises while tolerating distress and refraining from compulsions. Participants are also guided to set goals and type down the specific content of their intrusive thoughts and compulsive behaviours to keep track of their progress. Each session of the program is estimated to be approximately 5 minutes.

Experimental: Intervention group: Obsessive Compulsive Disorder Program

This 8-day program on cooperation aims to improve participants' collaborative skills and interpersonal wellness through a series of content learning and practice exercises. The time and duration of this program is matched to the obsessive compulsive disorder program to ensure that participants spend a similar amount of time and effort across both the intervention and active control conditions.

Control group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University of Singapore

Singapore, Singapore

Location

Related Publications (5)

  • 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.

    PMID: 29154165BACKGROUND
  • 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.

    PMID: 7726811BACKGROUND
  • 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.

    PMID: 12501574BACKGROUND
  • Frost, R. O., Marten, P., Lahart, C., & Rosenblate, R. The dimensions of perfectionism. Cognitive Therapy and Research. 1990; 14(5): 449-468.

    BACKGROUND
  • Lee Yoon Li M, Lee Si Min S, Sundermann O. Efficacy of the mHealth App Intellect in Improving Subclinical Obsessive-Compulsive Disorder in University Students: Randomized Controlled Trial With a 4-Week Follow-Up. JMIR Mhealth Uhealth. 2024 Dec 16;12:e63316. doi: 10.2196/63316.

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Stephanie Lee, Ph.D

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Assistant Professor

Study Record Dates

First Submitted

January 1, 2024

First Posted

January 11, 2024

Study Start

January 1, 2024

Primary Completion

March 1, 2024

Study Completion

July 7, 2024

Last Updated

July 1, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations