Obsessive-Compulsive DisorderNCT06202677
Effectiveness of a Self-guided Mobile Application in Improving Obsessive Compulsive Disorder Symptoms
A study testing Self-guided program on obsessive compulsive disorder and Self-guided program on cooperation in people with Obsessive-Compulsive Disorder, run by National University of Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Self-guided program on obsessive compulsive disorder and Self-guided program on cooperation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jan 2024to 7 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Self-guided program on obsessive compulsive disorder, Self-guided program on cooperation
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-guided program on obsessive compulsive disorderDevice
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.
Self-guided program on cooperationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Self-guided program on cooperation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 8 days (completion of intervention), 4 weeks (follow-up)
Secondary outcomes (1)
Change of depression, anxiety and stress symptoms
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.
Measured: Baseline, 8 days (completion of intervention), 4 weeks (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Jan 2024
- Primary completion1 Mar 2024
- Study completion7 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Intellect Pte. Ltd.
- Responsible party
- Principal investigator, Dr Oliver Suendermann, National University of Singapore
- Investigators
- Stephanie Lee, Ph.D, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202677
- Sponsor's protocol ID
- NUS-IRB-2023-444
- Status last verified
- Jun 2024
- First submitted
- 1 Jan 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29154165Lovibond 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.
PubMed 7726811Foa 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.
PubMed 12501574Frost, R. O., Marten, P., Lahart, C., & Rosenblate, R. The dimensions of perfectionism. Cognitive Therapy and Research. 1990; 14(5): 449-468.
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.
PubMed 39680884
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06202677
- Acronym / sponsor ID
- NUS-IRB-2023-444
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Intellect Pte. Ltd.
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 7 Jul 2024 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention group: Obsessive Compulsive Disorder Program | Experimental | Device: Self-guided program on obsessive compulsive disorderParticipants 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. |
| Control group | Active comparator | Device: Self-guided program on cooperationParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-guided program on obsessive compulsive disorderThis 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. | Device | Experimental: Intervention group: Obsessive Compulsive Disorder Program |
| Self-guided program on cooperationThis 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. | Device | Control group |
Primary outcome
Change of obsessive compulsive disorder symptoms
Time frame: 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.
1 secondary outcome
Change of depression, anxiety and stress symptoms
Time frame: Baseline, 8 days (completion of intervention), 4 weeks (follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Background: PubMed 29154165Bakker 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.
- Background: PubMed 7726811Lovibond 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.
- Background: PubMed 12501574Foa 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.
- BackgroundFrost, R. O., Marten, P., Lahart, C., & Rosenblate, R. The dimensions of perfectionism. Cognitive Therapy and Research. 1990; 14(5): 449-468.
- Derived from this study: PubMed 39680884Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Lee, Ph.D principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-guided program on obsessive compulsive disorder and Self-guided program on cooperation in people with Obsessive-Compulsive Disorder, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of obsessive compulsive disorder symptoms (time frame: Baseline, 8 days (completion of intervention), 4 weeks (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06202677, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.