Efficacy of a Brief Online Mindfulness and Self-Compassion Intervention (Mind-OP+) to Increase Connectedness

Depression Clinical Trial

Official title: Efficacy of a Brief Online Mindfulness and Self-Compassion Intervention (Mind-OP+) to Increase Connectedness: Randomized Controlled Trial

Status Completed

Clinical Trial Summary

Undergraduate students partook in an augmented, brief, online mindfulness and self-compassion-based program (Mind-OP+) to facilitate perceptions of connectedness. Participants were randomized into Mind-OP+ or waitlist control groups. It is hypothesized that connectedness at baseline will be negatively associated with mental health symptoms (depression, anxiety) and stress, and positively associated with self-compassion and dispositional mindfulness. Further, it is predicted that participants in the Mind-OP+ group will experience increases in connectedness compared with participants in the waitlist control condition. This study could provide support for a brief, convenient program to increase perceived connectedness, and thereby provide an option for students seeking protective factors for mental health and general resiliency.

Clinical Trial Description

All measures, modules and questionnaires were hosted on Qualtrics, an online surveying software.

Upon signing up for the study and providing written informed consent, participants had access to a pre-treatment package via a Qualtrics link, which consisted of a consent form, demographic questions, and all measures (SCS-SF, FCS, FFMQ-15, SNI, RNS, SCS-R, and DASS-21). Within one week of participants completing the pre-treatment package, the principal investigator sorted through the data to determine eligibility based on symptom criteria (mild to moderate depression and/or anxiety symptoms, and/or mild to moderate stress levels). Those who met criteria were randomly assigned to the waitlist group or treatment group using Research Randomizer, a web-based pseudo-random number generator. The principal investigator e-mailed ineligible participants, thanked them for their time, as well as provided them with a debriefing form and links to the Mind-OP+ modules for their personal use.

Each week for five weeks, the treatment group was emailed a package containing the Mind-OP+ module, the symptom measure (DASS-21), and the connectedness measures (SCS-R, RNS, and SNI). Additionally, other outcome measures (SCS-SF, FCS, and FFMQ-15) were e-mailed in the middle of the trial at the three-week point. The waitlist group received an e-mail with a Qualtrics link containing the same measures following the same schedule, but without the Mind-OP+ modules. The principal investigator sent reminders twice a week to both groups to ensure that participants were completing the packages, as a previous student trial of Mind-OP following the same reminder schedule had 59% of enrolled participants complete the intervention (Bueno et al., in preparation).

After completion of the five-week intervention, on the seventh week of the trial, all participants received the post-treatment package that contains all measures (SCS-SF, FCS, FFMQ-15, SNI, RNS, SCS-R, and DASS-21. One month following the completion of the study, all participants received another follow-up package containing all measures, a debrief form, and access to mental health resources. At this point, the principal investigator e-mailed the intervention modules to the waitlist group.

Following completion of data collection, the principal investigator conducted ten correlation analyses to examine zero-order correlation coefficients of baseline SCS-R and RNS scores with baseline DASS-21, FFMQ-15, FCS, SCS-SF, and SCS-SF - Common Humanity Subscale (SCS-SF-CH) scores. Two multilevel modeling analyses (MLM) were conducted to compare changes in scores on relatedness and social connectedness between the treatment group (Mind-OP+) and waitlist group over the 12-week trial duration (7-week intervention duration + at the one-month follow-up). Four serial mediation models analysed whether changes in mindfulness and self-compassion mediated relationships between treatment outcomes for both groups and changes in relatedness and social connectedness. Further, SNI scores were examined using two exploratory sign tests. ;

Related Conditions & MeSH terms

• Anxiety
• Depression
• Social Isolation
• Stress

• NCT number: NCT05871554
• Study type: Interventional
• Source: University of Regina
• Status: Completed
• Phase: N/A
• Start date: January 10, 2022
• Completion date: April 11, 2022