An interventional study of Self-guided program on obsessive compulsive disorder and Self-guided program on cooperation in Obsessive-Compulsive Disorder, sponsored by National University of Singapore. Status unknown at 1 site in Singapore. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-01.
Sponsored by National University of Singapore · Not applicable, Interventional, and Supportive care
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.
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.
626 studies on the registry are indexed under Obsessive-Compulsive Disorder; 162 are open to participants now.
This study's enrollment of 225 is above the median of 45 across 510 interventional studies indexed under Obsessive-Compulsive Disorder.
Browse Obsessive-Compulsive Disorder studies →National University of Singapore is the lead sponsor of 212 studies on the registry; 54 are open to participants now.
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Exclusion Criteria:
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
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
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.
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.
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.
Time frame: Baseline, 8 days (completion of intervention), 4 weeks (follow-up)
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.
Time frame: Baseline, 8 days (completion of intervention), 4 weeks (follow-up)
Perfectionism
The Frost Multidimensional Perfectionism Scale (FMPS; Frost et al.,1990) is a 35-item self-report scale which assesses perfectionism across 6 subscales: concern over mistakes (9 items), high personal standards (7 items), parental expectations (5 items), parental criticism (4 items), doubts about actions (4 items), and organisation (6 items). Each item is rated on a 5-point Likert scale ranging from Strongly disagree (1) to Strongly agree (5). The FMPS has demonstrated good internal consistency and convergent validity with other measures of perfectionism within non-clinical and clinical samples (Frost et al., 1990).
Time frame: Baseline
Engagement with the mobile application
The App Engagement Scale (AES; Bakker \& Rikard, 2018) assesses app engagement. Each item is rated on a 5-point Likert scale with scores ranging from definitely disagree (1) to definitely agree (5). The total score (ranging from 1-35) is the sum of all the items.
Time frame: 8 days (completion of intervention)
Plan to share: No
Ran from Jan 2024 to primary completion in Mar 2024, 2 months.
Of 230 non-industry interventional studies with no phase under Obsessive-Compulsive Disorder, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 68. This study's 2 months is below that.
Counting every sponsor, half of 232 studies reached it within 43 months; a quarter within 22 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Obsessive-Compulsive Disorder →
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