Clinical trial NCT05871554: Efficacy of a Brief Online Mindfulness and Self-Compassion Intervention (Mind-OP+) to Increase Connectedness
Official title: Efficacy of a Brief Online Mindfulness and Self-Compassion Intervention (Mind-OP+) to Increase Connectedness: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Stress
Social Isolation
Anxiety
Lead sponsor: University of Regina
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* University student
* Mild to moderate levels of anxiety, depression, and/or stress

Exclusion Criteria:

* Non university students
* Below mild levels of anxiety, depression, and stress

Primary outcomes:
measure: Relatedness Needs Subscale (RNS)
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, and Week 11
measure: The Social Connectedness Scale - Revised (SCS-R)
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, and Week 11
measure: Berkman-Syme Social Network Index (SNI)
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, and Week 11
Secondary outcomes:
measure: The Depression, Anxiety, and Stress Scale - 21 Items (DASS-21)
timeFrame: Baseline, Week 6, and Week 11
measure: The Five-Facet Mindfulness Questionnaire 15 (FFMQ-15)
timeFrame: Baseline, Week 6, and Week 11
measure: Fears of Compassion Scale (FCS)
timeFrame: Baseline, Week 6, and Week 11
measure: The Self-Compassion Scale-Short Form (SCS-SF)
timeFrame: Baseline, Week 6, and Week 11
Other outcomes:
Locations:
city: Regina
country: Canada
facility: University of Regina
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Christine Bueno, B.A. (Hons)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beshai S, Bueno C, Yu M, Feeney JR, Pitariu A. Examining the effectiveness of an online program to cultivate mindfulness and self-compassion skills (Mind-OP): Randomized controlled trial on Amazon's Mechanical Turk. Behav Res Ther. 2020 Nov;134:103724. doi: 10.1016/j.brat.2020.103724. Epub 2020 Sep 10.