Clinical trial NCT05347719: Virtual Mindfulness Training for Adults With History of Depression
Official title: Virtual Mindfulness Training for Adults With History of Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Mindfulness Based Cognitive Therapy
Major Depressive Disorder
Virtual Delivery
Community Health
Lead sponsor: Clemson University
Sponsor class: OTHER
Collaborators: name: Prisma Health-Upstate
First posted: 2022-04-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Depression Severity
timeFrame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
measure: Change in Psychiatric Distress
timeFrame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
Secondary outcomes:
measure: Change in Perceived stress
timeFrame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
measure: Change in Posttraumatic stress
timeFrame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
measure: Change in Adherence to Medication Assisted Treatment (MAT)
timeFrame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
measure: Change in Mindfulness skills
timeFrame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
measure: Change in Perceived Quality of Life (health, well-being)
timeFrame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
measure: Change in Extent of mindfulness self-practice
timeFrame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
measure: Change in Frequency of major depressive disorder relapse episodes
timeFrame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
Other outcomes:
measure: Change in Emotion regulation
timeFrame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
measure: Change in Savoring
timeFrame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
measure: Intervention fidelity
timeFrame: Intervention fidelity will be assessed over the course of 8 weeks for each intervention group cohort.
Locations:
city: Clemson
country: United States
facility: Clemson University
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
Study officials:
affiliation: Clemson University
name: Lu Shi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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