DepressionNCT05871554
Efficacy of a Brief Online Mindfulness and Self-Compassion Intervention (Mind-OP+) to Increase Connectedness
A study testing Mind-OP+ in people with Depression and Stress, run by University of Regina at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Stress, Social Isolation
- What is being tested?
- Mind-OP+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jan 2022to 11 Apr 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- University student
- Mild to moderate levels of anxiety, depression, and/or stress
Who cannot join
- Non university students
- Below mild levels of anxiety, depression, and stress
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Brief Online Mindfulness and Self-Compassion Intervention (Mind-OP+) to Increase Connectedness: Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Depression, Stress, Social Isolation, Anxiety
- Being tested
- Mind-OP+
- Medical subject headings
- Depression, Social Isolation, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-OP+Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mind-OP+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
Change from Baseline in Depression, Anxiety and Stress Scores at Week 6 and Week 11. Total score range: 0 - 126. Lower scores are indicative of less symptoms of depression and anxiety and lower levels of stress (a better outcome). Total score is calculated by summing scale items and multiplying by 2.
Measured: Baseline, Week 6, and Week 11
The Five-Facet Mindfulness Questionnaire 15 (FFMQ-15)
Change from Baseline in Mindfulness Scores at Week 6 and Week 11. Total score range: 15 - 75. Lower scores are indicative of less trait mindfulness (worse outcome). Total score is computed by summing all scale items.
Measured: Baseline, Week 6, and Week 11
Fears of Compassion Scale (FCS)
Change from Baseline in Fears of Compassion Scores at Week 6 and Week 11. Total score range: 0 - 152. Lower scores are indicative of less fears of compassion (better outcome). Total score is computed by summing all scale items.
Measured: Baseline, Week 6, and Week 11
The Self-Compassion Scale-Short Form (SCS-SF)
Change from Baseline in Self-Compassion Scores at Week 6 and Week 11. Total score range: 1 - 5. Lower scores are indicative of less self-compassion (worse outcome). Total score is computed by summing all items and calculating an average.
Measured: Baseline, Week 6, and Week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start10 Jan 2022
- Primary completion11 Apr 2022
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Bueno, B.A. (Hons), Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871554
- Sponsor's protocol ID
- 2021-132
- Status last verified
- May 2023
- First submitted
- 12 May 2023
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32942203
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Brief Online Mindfulness and Self-Compassion Intervention (Mind-OP+) to Increase Connectedness: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05871554
- Acronym / sponsor ID
- 2021-132
- Conditions
- Depression, Stress, Social Isolation, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 23 May 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Mind-OP+Participants are allocated to a treatment condition where they participate in surveys and online video modules for 11 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- University student
- Mild to moderate levels of anxiety, depression, and/or stress
Key exclusion criteria (2 listed)
- Non university students
- Below mild levels of anxiety, depression, and stress
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 |
|---|---|---|
| Mind-OP+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. | Behavioural | Treatment |
Primary outcome
Relatedness Needs Subscale (RNS)
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, and Week 11
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.
The Social Connectedness Scale - Revised (SCS-R)
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, and Week 11
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.
Berkman-Syme Social Network Index (SNI)
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, and Week 11
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.
4 secondary outcomes
The Depression, Anxiety, and Stress Scale - 21 Items (DASS-21)
Time frame: Baseline, Week 6, and Week 11
The Five-Facet Mindfulness Questionnaire 15 (FFMQ-15)
Time frame: Baseline, Week 6, and Week 11
Fears of Compassion Scale (FCS)
Time frame: Baseline, Week 6, and Week 11
The Self-Compassion Scale-Short Form (SCS-SF)
Time frame: Baseline, Week 6, and Week 11
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Background: PubMed 32942203Beshai 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.
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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.
Christine Bueno, B.A. (Hons) principal investigator
University of Regina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-OP+ in people with Depression and Stress, run by University of Regina at 1 site in Canada.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 23 May 2023. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relatedness Needs Subscale (RNS) (time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, and Week 11). The study lists 3 primary outcomes in all. 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 NCT05871554, which also lists 1 linked publication.
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 23 May 2023.