NCT05347719Completed
Virtual Mindfulness Training for Adults With History of Depression
Source: ClinicalTrials.gov · Last updated 20 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 28 (actual)
- First submitted
- 14 Apr 2022
- Start date
- 1 Sept 2022
- Primary completion date
- 31 May 2024
- Lead sponsor
- Clemson University
- Diseases
- Depression
- NCT number
- NCT05347719
What you commit to
- Study type: Interventional
- Participants enrolled: 28
- From 1 Sept 2022 to the primary completion date, 31 May 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previously completed or currently attending a standard MBCT intervention
Other illness
- current psychosis, dementia, moderate to severe traumatic brain injury, or active suicidality
- 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 active diagnosis of Bipolar Disorder
Other
- persistent antisocial behavior
- persistent self-injury requiring clinical management
- an acute episode of MDD (met two or more MDD criteria in the past two weeks)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clemson University Coordinator of this site? Confirm its status | Clemson | United States | Unknown status |
| Prisma Health Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.