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

NCT05871554 | Completed

• 1 other identifier: 2021-132
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Stress; Social Isolation; Anxiety

Outcome Measures

Primary Outcomes (3)

• Relatedness Needs Subscale (RNS)

  Change from Baseline in Relatedness Scores at Weeks 1-6 and Week 11. Total score range: 1-7. Lower values are indicative of lower relatedness needs satisfaction (a worse outcome). Total scores are computed by summing all scale items and calculating an average.

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, and Week 11

• The Social Connectedness Scale - Revised (SCS-R)

  Change from Baseline in Social Connectedness Scores at Weeks 1-6 and Week 11. Total score range: 20 - 120. Lower values are indicative of lower levels of social connectedness (a worse outcome). Total scores are computed by summing all scale items.

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, and Week 11

• Berkman-Syme Social Network Index (SNI)

  Change from Baseline in Social Network Scores at Weeks 1-6 and Week 11. Total score range: 0-4. Lower scores are indicative of more isolation (a worse outcome). Total score is a composite score calculated by assigning one point for each relationship category endorsed (i.e., marriage, friends, relatives, and group activities) for up to a total of 4 points.

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, and Week 11

Secondary Outcomes (4)

• The Depression, Anxiety, and Stress Scale - 21 Items (DASS-21)

  Baseline, Week 6, and Week 11

• The Five-Facet Mindfulness Questionnaire 15 (FFMQ-15)

  Baseline, Week 6, and Week 11

• Fears of Compassion Scale (FCS)

  Baseline, Week 6, and Week 11

• The Self-Compassion Scale-Short Form (SCS-SF)

  Baseline, Week 6, and Week 11

Study Arms (2)

Waitlist

NO INTERVENTION

Participants are allocated to a waitlist condition where they participate in surveys for 11 weeks. Participants receive access to the treatment modules after completing the final survey after the 11th week.

Treatment

EXPERIMENTAL

Participants are allocated to a treatment condition where they participate in surveys and online video modules for 11 weeks.

Behavioral: Mind-OP+

Interventions

Mind-OP+ BEHAVIORAL

Mind-OP is an online program designed to cultivate mindfulness and self-compassion developed by Beshai and his team. Mind-OP is self-guided, with four modules administered at a pace of one module per week (four weeks total). The version used for this study, Mind-OP+, is five weeks total, containing an extra module focused on connectedness. The modules contain psychoeducational videos, guided audio meditations, goal-setting and motivational interviewing inspired exercises. Participants also have opportunities to engage with meditations and other exercises embedded within each module. The first module (Week 1) introduces the concept of mindfulness. The second module (Week 2) focuses on attention to bodily sensations and thoughts. The third module (Week 3) introduces the concept of self-compassion. The fourth module (Week 4) focuses on the self-kindness component of self-compassion. The fifth module (Week 5) focuses on the concept of connectedness.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Regina: lead

Study Sites (1)

University of Regina

Regina, Saskatchewan, Canada

Location

Related Publications (1)

• 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.

  PMID: 32942203 BACKGROUND

MeSH Terms

Conditions

Depression; Social Isolation; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Social Behavior; Mental Disorders

Study Officials

• Christine Bueno, B.A. (Hons)

  University of Regina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 23, 2023
• Study Start: January 10, 2022
• Primary Completion: April 11, 2022
• Study Completion: April 11, 2022
• Last Updated: May 23, 2023

Record last verified: 2023-05

Locations

CA (1)