- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04740879
The Effects of the Be Mindful Intervention in Previously Depressed Individuals Experiencing Subclinical Symptoms
The Effects of the "Be Mindful" Intervention in Previously Depressed College Students Currently Experiencing Subclinical Symptoms of Depression
Study Overview
Status
Intervention / Treatment
Detailed Description
Participant outcome variables will be assessed weekly for the first month after baseline. This will include the primary dependent variable (i.e., depressive symptoms), but will also include variables that will be explored as potential mechanisms of change (i.e., mindfulness, decentering, rumination, worry, self-compassion, and dysfunctional attitudes). The final weekly assessment will represent the Post-Intervention assessment.
Brief follow-up assessments of the primary dependent variable will be given 1-month and 2-months after the final weekly questionnaire. There will be a 3-month assessment that measures potential mechanisms of change in addition to the primary dependent variable.
After the 3-month follow-up, the Waitlist Control condition will be given access to the intervention. All participants (i.e., in both conditions) will be asked to complete another month of weekly questionnaires. These questionnaires will be identical to the first set of weekly questionnaires, and will allow mechanisms of change to be evaluated in the Waitlist Control condition.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Buffalo, New York, United States, 14260
- State University of New York at Buffalo (SUNY at Buffalo)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- currently experiencing mild to moderate depressive symptoms (Patient Health Questionnaire 9 Current scores between 5 and 14)
- meet Diagnostic and Statistical Manual of Mental Disorders (fifth edition; DSM-5) criteria for Past Major Depressive Disorder (determined by clinical interview)
Exclusion Criteria:
- responses suggest they have never experienced a Major Depressive Episode
- responses suggest they are not currently experiencing sub-threshold symptoms of depression
- they state they are not open to learning mindfulness or meditation techniques
- they indicate they are currently receiving therapeutic treatment for depression or stress management elsewhere
- they indicate their age is not between 18 and 65
- they state they do not currently live in New York State
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
The Intervention condition will be provided with access to the 4-week online Mindfulness-Based Cognitive Therapy course "Be Mindful" immediately after randomization to group.
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The online 4-week Be Mindful intervention was designed to follow the same outline as typical in-person 8-week MBCT courses.
Week 1 and Week 2 introduce the topic of mindfulness and encourage its daily use, whereas Week 3 and Week 4 teach the individual to decenter from thoughts and utilize mindfulness when coping with stressors.
Each week focuses on a separate mindfulness topic, which is initially presented to the individual in a short (under 5 minute) video containing didactic information and an overview of the experiential activities that will be introduced in subsequent videos.
The intervention is provided entirely through audio, video, and text provided on the Be Mindful website (BeMindfulOnline.com).
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Other: Waitlist Control
The Waitlist Control condition will be provided with access to the 4-week online Mindfulness-Based Cognitive Therapy course "Be Mindful" approximately 4 months after randomization to group.
|
The online 4-week Be Mindful intervention was designed to follow the same outline as typical in-person 8-week MBCT courses.
Week 1 and Week 2 introduce the topic of mindfulness and encourage its daily use, whereas Week 3 and Week 4 teach the individual to decenter from thoughts and utilize mindfulness when coping with stressors.
Each week focuses on a separate mindfulness topic, which is initially presented to the individual in a short (under 5 minute) video containing didactic information and an overview of the experiential activities that will be introduced in subsequent videos.
The intervention is provided entirely through audio, video, and text provided on the Be Mindful website (BeMindfulOnline.com).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change in Depressive Symptoms from Baseline as Measured by the Patient Health Questionnaire 9 Post-Intervention
Time Frame: weekly during intervention, approximately 1-2 months
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Participants are asked to rate items on a scale of 0 (Not at all) to 3 (Nearly every day).
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weekly during intervention, approximately 1-2 months
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Mean Change in Depressive Symptoms from Baseline as Measured by the Patient Health Questionnaire 9 at 3-Month Follow-Up
Time Frame: at regular intervals until 3-month follow-up (approximately 4-5 months after the start of the study)
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Participants are asked to rate items on a scale of 0 (Not at all) to 3 (Nearly every day).
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at regular intervals until 3-month follow-up (approximately 4-5 months after the start of the study)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change in Mindfulness from Baseline as Measured by the Five Factor Mindfulness Questionnaire Short Form
Time Frame: through study completion, which can take up to 6 months
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Participants are asked to rate items on a scale of 1 (never or rarely true) to 5 (very often or always true).
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through study completion, which can take up to 6 months
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Mean Change in Decentering from Baseline as Measured by the Toronto Mindfulness Scale
Time Frame: through study completion, which can take up to 6 months
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Participants are asked to rate items on a scale of 0 (not at all) to 4 (very much).
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through study completion, which can take up to 6 months
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Mean Change in Rumination from Baseline as Measured by the Ruminative Response Questionnaire
Time Frame: through study completion, which can take up to 6 months
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Participants are asked to rate items on a scale of 1 (Almost never) to 4 (Almost always).
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through study completion, which can take up to 6 months
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Mean Change in Worry from Baseline as Measured by the Penn State Worry Questionnaire
Time Frame: through study completion, which can take up to 6 months
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Participants are asked to rate items on a scale of 1 (Not at all typical of me) to 5 (Very typical of me).
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through study completion, which can take up to 6 months
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Mean Change in Self-Compassion from Baseline as Measured by the Self-Compassion Scale Short Form
Time Frame: through study completion, which can take up to 6 months
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Participants are asked to rate items on a scale of 1 (Almost never) to 4 (Almost always).
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through study completion, which can take up to 6 months
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Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Dysfunctional Attitudes Scale (Short Form 1)
Time Frame: through study completion, which can take up to 6 months
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Participants are asked to rate items on a scale of 1 (totally agree) to 4 (totally disagree).
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through study completion, which can take up to 6 months
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Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Rosenberg Self-Esteem Scale
Time Frame: through study completion, which can take up to 6 months
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Participants are asked to rate items on a scale of 0 (strongly disagree) to 3 (strongly agree).
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through study completion, which can take up to 6 months
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Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Single-Item Self-Esteem Scale
Time Frame: through study completion, which can take up to 6 months
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Participants are asked to rate items on a scale of 1 (Not Very True of Me) to 5 (Very True of Me).
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through study completion, which can take up to 6 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Meghan E Bauer, MA, State University of New York at Buffalo
- Principal Investigator: John E Roberts, PhD, State University of New York at Buffalo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00005212
- SU-20-01 (Other Grant/Funding Number: State University of New York at Buffalo)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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