Depressive SymptomsNCT03769233
Mindfulness for Emerging Adults Experiencing Anxious and/or Depressive Symptoms
A study testing Mindfulness-based Intervention in people with Depressive Symptoms and Anxious Symptoms, run by York University at 1 site in Canada.
Trial summary
Emerging adults (EA; 18 to 29 years old) in Canada are among the age group with highest risk of developing mental health issues. Despite this, they experience especially long wait-times for mental health services. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Depressive Symptoms, Anxious Symptoms
- What is being tested?
- Mindfulness-based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- 14 Dec 2018to 1 May 2019
- 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 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- consenting Emerging Adults
- Ability to communicate, in written and spoken English
Who cannot join
- Minimal depressive and anxious symptoms (score below 10 and 8 on the PHQ-9/GAD-7
- Current substance abuse or dependence, psychosis or mania
- Current self-injurious behavior of past suicide attempt
- Previously completed >4 weeks of an MBI, or general Cognitive behavioral Therapy, in the past 3 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 5-week Mindfulness Program for Emerging Adults Experiencing Anxious and/or Depressive Symptoms
Emerging adults (EA; 18 to 29 years old) in Canada are among the age group with highest risk of developing mental health issues. Despite this, they experience especially long wait-times for mental health services. To date, there has been minimal research into developmentally appropriate treatment options for the EA population. Mindfulness-based interventions (MBIs) are emerging as a potential treatment to address this need. MBIs are group-based psychological treatments for coping with distress, with the goal of improving mental health. Unfortunately, these 'traditional' MBIs are very demanding in terms of time and homework and are therefore not sufficiently feasible for the demanding schedules of EA university students. Instead, recent studies suggest a role for briefer MBIs in addressing mental health symptom burden, well-being and reducing acute stress symptoms. The brevity of these interventions make them theoretically better suited for EA university populations. High quality research, including controlled clinical trials are needed to demonstrate whether MBIs can provide efficacious treatment to improve the lives of EA university students. The current study will test the efficacy of a five-week MBI baseline within-subject controlled trial.
- Conditions
- Depressive Symptoms, Anxious Symptoms
- Being tested
- Mindfulness-based Intervention
- Keywords
- Mindfulness, Well-being, Emotion Regulation, Perceived Stress, Self-Compassion
- Medical subject headings
- Depression, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based InterventionBehavioural
MBI will be delivered in group format, 90 minutes per week, for 5 consecutive weeks with 6-15 participants per group.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based Intervention | Experimental | 5 week, manual-based group MBI treatment for depressive and anxious symptoms Receives: Behavioral: Mindfulness-based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Depressive Symptoms at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5 Weeks
Patient Health Questionnaire-9 (PHQ-9): Scale used to measure Depressive Symptoms, with higher scores reflecting greater levels of depressive symptoms
Measured: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5
Change from Baseline Anxious Symptoms at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5 Weeks
Generalized Anxiety Disorder-7 (GAD-7): Scale used to measure Anxious Symptoms, with higher scores reflecting greater levels of anxious symptoms
Measured: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)
Change from Baseline Mental Wellbeing at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5 Weeks
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Scale used to measure Mental Wellbeing, with higher scores reflecting greater levels of mental wellbeing
Measured: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)
Secondary outcomes (4)
Change from Baseline Perceived Stress at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5
10-item Perceived Stress Scale (PSS-10): Scale used to measure Perceived Stress, with higher scores reflecting greater levels of perceived stress
Measured: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)
Change from Baseline Emotion Regulation Strategies at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5
Emotion Regulation Questionnaire (ERQ): Scale used to measure Emotion Regulation, with higher scores reflecting greater levels of emotion regulation strategies
Measured: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)
Change from Baseline Self-Compassion at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5
Self-Compassion Scale - Short Form (SCS-SF): Scale used to measure self-compassion, with higher scores reflecting greater levels of self-compassion
Measured: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)
Change from Baseline Mindful Awareness at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5
Five-Facet Mindfulness Questionnaires (FFMQ): Scale used to measure mindful awareness, with higher scores reflecting greater levels of mindfulness facets
Measured: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start14 Dec 2018
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jennine Rawana, York University
- Investigators
- Dr. Jennine S Rawana, PhD,C.Psych., Principal investigator, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769233
- Sponsor's protocol ID
- E2018-349
- Status last verified
- Apr 2021
- First submitted
- 6 Dec 2018
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 5-week Mindfulness Program for Emerging Adults Experiencing Anxious and/or Depressive Symptoms
- ClinicalTrials.gov ID
- NCT03769233
- Acronym / sponsor ID
- E2018-349
- Conditions
- Depressive Symptoms, Anxious Symptoms
- Keywords
- Mindfulness, Well-being, Emotion Regulation, Perceived Stress, Self-Compassion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 7 Dec 2018 (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.
Emerging adults (EA; 18 to 29 years old) in Canada are among the age group with highest risk of developing mental health issues. Despite this, they experience especially long wait-times for mental health services. To date, there has been minimal research into developmentally appropriate treatment options for the EA population. Mindfulness-based interventions (MBIs) are emerging as a potential treatment to address this need. MBIs are group-based psychological treatments for coping with distress, with the goal of improving mental health. Unfortunately, these 'traditional' MBIs are very demanding in terms of time and homework and are therefore not sufficiently feasible for the demanding schedules of EA university students. Instead, recent studies suggest a role for briefer MBIs in addressing mental health symptom burden, well-being and reducing acute stress symptoms. The brevity of these interventions make them theoretically better suited for EA university populations. High quality research, including controlled clinical trials are needed to demonstrate whether MBIs can provide efficacious treatment to improve the lives of EA university students. The current study will test the efficacy of a five-week MBI baseline within-subject controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based Intervention | Experimental | Behavioral: Mindfulness-based Intervention5 week, manual-based group MBI treatment for depressive and anxious symptoms |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- consenting Emerging Adults
- Ability to communicate, in written and spoken English
Key exclusion criteria (4 listed)
- Minimal depressive and anxious symptoms (score below 10 and 8 on the PHQ-9/GAD-7
- Current substance abuse or dependence, psychosis or mania
- Current self-injurious behavior of past suicide attempt
- Previously completed >4 weeks of an MBI, or general Cognitive behavioral Therapy, in the past 3 years
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 |
|---|---|---|
| Mindfulness-based InterventionMBI will be delivered in group format, 90 minutes per week, for 5 consecutive weeks with 6-15 participants per group. | Behavioural | Mindfulness-based Intervention |
Primary outcome
Change from Baseline Depressive Symptoms at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5 Weeks
Time frame: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5
Patient Health Questionnaire-9 (PHQ-9): Scale used to measure Depressive Symptoms, with higher scores reflecting greater levels of depressive symptoms
Change from Baseline Anxious Symptoms at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5 Weeks
Time frame: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)
Generalized Anxiety Disorder-7 (GAD-7): Scale used to measure Anxious Symptoms, with higher scores reflecting greater levels of anxious symptoms
Change from Baseline Mental Wellbeing at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5 Weeks
Time frame: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Scale used to measure Mental Wellbeing, with higher scores reflecting greater levels of mental wellbeing
4 secondary outcomes
Change from Baseline Perceived Stress at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5
Time frame: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)
Change from Baseline Emotion Regulation Strategies at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5
Time frame: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)
Change from Baseline Self-Compassion at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5
Time frame: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)
Change from Baseline Mindful Awareness at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5
Time frame: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)
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 13 Apr 2021.
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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.
Dr. Jennine S Rawana, PhD,C.Psych. principal investigator
York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Intervention in people with Depressive Symptoms and Anxious Symptoms, run by York University 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 4 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 13 Apr 2021. 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?
Change from Baseline Depressive Symptoms at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5 Weeks (time frame: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5). 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?
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 13 Apr 2021.