The Effects of the Be Mindful Intervention in Previously Depressed Individuals Experiencing Subclinical Symptoms

Study Overview
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Brief Summary
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This study is designed to help individuals cope with their current depressive symptoms by providing them access to a 4-week online Mindfulness-Based Cognitive Therapy: Be Mindful. Research has shown that completion of the Be Mindful intervention can reduce depressive symptoms in a community sample, and this study aims to evaluate if it can also help reduce depressive symptoms in individuals with a confirmed history of depression. Participants will either receive the intervention at the start of the study or four months after the start of the study (i.e., at 3-month follow-up), which will allow research staff to assess if reductions in depression are due to the intervention or something else. Research staff will also evaluate if the reduction in depressive symptoms lasts over the three months following intervention, and will investigate possible reasons for the change in depression (i.e., why the intervention produces change).

Detailed Description
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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.

Official Title
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The Effects of the Be Mindful Intervention in Previously Depressed College Students Currently Experiencing Subclinical Symptoms of Depression

Conditions
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Depressive Symptoms, Major Depressive Disorder, Recurrent, in Remission

Intervention / Treatment
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* Behavioral: Be Mindful


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Behavioral: Be Mindful<br>* 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).<br>|
| Other: Waitlist Control<br>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. | Behavioral: Be Mindful<br>* 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).<br>|

What is the study measuring?
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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 | Participants are asked to rate items on a scale of 0 (Not at all) to 3 (Nearly every day). | weekly during intervention, approximately 1-2 months | 
| Mean Change in Depressive Symptoms from Baseline as Measured by the Patient Health Questionnaire 9 at 3-Month Follow-Up | Participants are asked to rate items on a scale of 0 (Not at all) to 3 (Nearly every day). | at regular intervals until 3-month follow-up (approximately 4-5 months after the start of the study) | 

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 | Participants are asked to rate items on a scale of 1 (never or rarely true) to 5 (very often or always true). | through study completion, which can take up to 6 months | 
| Mean Change in Decentering from Baseline as Measured by the Toronto Mindfulness Scale | Participants are asked to rate items on a scale of 0 (not at all) to 4 (very much). | through study completion, which can take up to 6 months | 
| Mean Change in Rumination from Baseline as Measured by the Ruminative Response Questionnaire | Participants are asked to rate items on a scale of 1 (Almost never) to 4 (Almost always). | through study completion, which can take up to 6 months | 
| Mean Change in Worry from Baseline as Measured by the Penn State Worry Questionnaire | Participants are asked to rate items on a scale of 1 (Not at all typical of me) to 5 (Very typical of me). | through study completion, which can take up to 6 months | 
| Mean Change in Self-Compassion from Baseline as Measured by the Self-Compassion Scale Short Form | Participants are asked to rate items on a scale of 1 (Almost never) to 4 (Almost always). | through study completion, which can take up to 6 months | 
| Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Dysfunctional Attitudes Scale (Short Form 1) | Participants are asked to rate items on a scale of 1 (totally agree) to 4 (totally disagree). | through study completion, which can take up to 6 months | 
| Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Rosenberg Self-Esteem Scale | Participants are asked to rate items on a scale of 0 (strongly disagree) to 3 (strongly agree). | through study completion, which can take up to 6 months | 
| Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Single-Item Self-Esteem Scale | Participants are asked to rate items on a scale of 1 (Not Very True of Me) to 5 (Very True of Me). | through study completion, which can take up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness Based Cognitive Therapy, Be Mindful Intervention, Past Major Depressive Disorder, Major Depressive Disorder, Depressive Symptoms, Mechanisms of Change