Virtual Mindfulness Training for Adults With History of Depression

Study Overview
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Brief Summary
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Mindfulness Based Cognitive Therapy (MBCT) has shown to be an effective method of preventing relapse of an episode Major Depressive Disorder (MDD). MBCT is a group program that integrates mindfulness skills training with cognitive-behavioral strategies. However, the cost of MBCT is not affordable to many families. The aim of this study is to explore the feasibility and efficacy of an MBCT intervention designed to be delivered at low cost through a virtual delivery format. This study will recruit 240 participants who are in remission from depression and randomize them to an MBCT intervention group or treatment as usual (TAU) for the wait list control group. The wait list control group will complete the intervention after the MBCT intervention group. Assessment administered at pre-intervention (baseline), post-intervention for experimental group, and post-intervention for the wait list control group and follow-up for experimental group. The primary outcome is to test the efficacy of this community-based delivery in reducing depression severity and psychiatric distress in the relapse of an episode of MDD. The secondary outcomes include perceived stress, post-traumatic stress symptoms, adherence to treatment plans not given as part of this study, frequency of relapse of MDD, mindfulness skills, and quality of life. This study will also examine the following potential moderators and correlates of intervention outcomes: comorbid diagnoses, life events history, and MBCT intervention adherence. Finally, the study will examine the following mediators of intervention outcome: mindfulness skills, emotion regulation skills, executive functioning skills, savoring, and positive and negative affect.

Detailed Description
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Mindfulness Based Cognitive Therapy (MBCT) has shown to be an effective method of preventing relapse of an episode Major Depressive Disorder (MDD). MBCT is a group program that integrates mindfulness skills training with cognitive-behavioral strategies. However, the cost of MBCT is not affordable to many families. The aim of this study is to explore the feasibility and efficacy of an MBCT intervention designed to be delivered at low cost through a virtual delivery format. The study will recruit 240 participants who are in remission from depression and randomize them to an MBCT intervention group or treatment as usual (TAU) for the wait list control group. The wait list control group will complete the intervention after the MBCT intervention group. Assessments will be administered at pre-intervention (baseline), post-intervention for experimental group (week 8), and post-intervention for the wait list control group and follow-up for experimental group (week 16). The primary outcome is to test the efficacy of this community-based delivery in reducing depression severity and psychiatric distress in the relapse of an episode of MDD. The secondary outcomes include perceived stress, post-traumatic stress symptoms, adherence to treatment plans not given as part of this study, frequency of relapse of MDD, mindfulness skills, and quality of life. This study will also examine the following potential moderators and correlates of intervention outcomes: comorbid diagnoses, life events history, and MBCT intervention adherence. Finally, this study will examine the following mediators of intervention outcome: mindfulness skills, emotion regulation skills, executive functioning skills, savoring, and positive and negative affect.

Official Title
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Virtual Mindfulness Training for Adults With History of Depression

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Behavioral: MBCT Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be over 18 years of age be a resident of upstate South Carolina or Prisma Health beneficiary have a SCID confirmed diagnosis of a prior MDD episode be willing to share contact information have English literacy 6th grade or above be able to attend intervention sessions. Exclusion Criteria: current psychosis, dementia, moderate to severe traumatic brain injury, or active suicidality persistent antisocial behavior persistent self-injury requiring clinical management an acute episode of a substance use disorder episode (met two or more SUD criteria in the past two weeks, excluding for tobacco or marijuana use) an acute episode of MDD (met two or more MDD criteria in the past two weeks) an active diagnosis of Bipolar Disorder previously completed or currently attending a standard MBCT intervention

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: To achieve our study aims, we designed a randomized, controlled trial with a treatment as usual (TAU) control group. A total of 240 eligible participants will be randomized to either an MBCT intervention group (Group 1) or an TAU control (Group 2). In Phase I, Group 1 will complete the intervention and Group 2 will remain in TAU. In Phase II , Group 2 will complete the intervention and Group 1 will continue TAU. Depending on the recruitment site, TAU may consist of receiving psychotherapy, pharmacotherapy, or combined treatment within an academic medical center. Data collection will be completed at baseline, post-intervention for Group 1 and pre-intervention for Group 2, and after follow-up for Group 1 and post-intervention for Group 2. This design allows us to provide fair treatment for both trial arms as well as allowing for follow-up assessment of Group 1.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBCT Intervention<br>Eight weekly two-hour mindful MBCT intervention sessions led by a trained healthcare provider. Post-intervention, the experimental group will receive treatment as usual. | Behavioral: MBCT Intervention<br>* Eight weekly two-hour mindful MBCT intervention sessions involving training in mindfulness meditation and cognitive-behavioral methods. Sessions will be designed to increase participant awareness of internal reactions that trigger relapse in MDD and to provide participants with techniques to detach from dysfunctional cognitive processes and redirect their attention to experiences. Outside of the sessions, participants will be assigned daily homework exercises and provided with handouts and audio recordings of mindfulness exercises to use in their practice.<br>|
| No Intervention: Wait List Control<br>Participants will engage in treatment as usual during the baseline period. After the experimental group completes the MBCT intervention, the wait list control group will complete the MBCT intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression Severity | Depression severity will be assessed with the Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer & Williams 2001). PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe, and severe depression. | Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group) | 
| Change in Psychiatric Distress | Psychiatric distress will be measured using the depression and anxiety subscales of the Brief Symptom Inventory (BSI; Derogatis & Melisaratos,1983). Items, such as your feelings being easily hurt, are ranked on a 5-point scale ranging from 0 (not at all) to 4 (extremely). Higher scores represent higher intensity of distress during the past week. | Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Perceived stress | Perceived stress will be assessed with the Perceived Stress Scale-4 (Warting et al., 2013). The questions in this scale ask you about your feelings and thoughts related to stress during the last month, with 0 representing seldom and 4 representing very often. Higher scores are correlated to more stress. | Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group) | 
| Change in Posttraumatic stress | The PTSD CheckList - Civilian Version (PCL-C) will be used to assess PTSD symptoms (Ruggiero et al., 2003). The PCL is a self-report scale for PTSD comprising 17 items that correspond to the key symptoms of PTSD. Respondents indicate how much they have been bothered by a symptom over the past month using a 5-point (1-5) scale, with high scores characterize higher intensity of PTSD. | Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group) | 
| Change in Adherence to Medication Assisted Treatment (MAT) | Adherence to other medical treatments not given as part of this study will be assessed with the Adherence to Refills and Medications Scale (ARMS; Kripalani et al., 2009). The ARMS scale is a 12 item scale that measures adherence to medications. | Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group) | 
| Change in Mindfulness skills | FFMQ-15: 15-item Five-Facet Mindfulness Questionnaire https://www.sussexpartnership.nhs.uk/sites/default/files/documents/jenny_gus_short_ffmq-15_june_16.pdf. The FFMQ-15 measures 5 subscales of mindfulness: Observing, Describing, Acting with Awareness, Non-judgement, Non-reactivity; Scores range from 15 to 75, with higher scores indicating higher levels of mindfulness skills. | Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group) | 
| Change in Perceived Quality of Life (health, well-being) | Quality of life will be assessed with the World Health Organization Quality of Life (WHOQOL-BREF; World Health Organization, 2004). The 26-item scale assesses quality of life, health, and other areas of wellbeing. Items are measured on a five-point scale. Higher scores represent higher quality of life. | Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group) | 
| Change in Extent of mindfulness self-practice | Participants will be asked the following questions: Besides the sessions you may have attended as part of this study, on your own, 'Did you engage in mindfulness meditation or other mindfulness practices in the past two months (8 weeks)?', 'How many days per week did you engage in mindfulness meditation or other mindfulness practices?', 'How long in minutes did you meditate per session of mindfulness meditation?', 'Describe your practice of mindfulness (what exercises/activities/techniques did you practice?).' For quantitative analyses, we will use the variable representing number of days of mindfulness practice per week. We will also assess the number of sessions attended, number of non-completers, and reasons for dropout. | Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group) | 
| Change in Frequency of major depressive disorder relapse episodes | The number of Major depressive relapse episodes will be identified using the ICD-10 codes for MDD in the DSM-5 (First, 2014). | Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness Based Cognitive Therapy, Major Depressive Disorder, Virtual Delivery, Community Health