NCT05859386: OMM

Optimizing Mindfulness Based Cognitive Therapy (MBCT) Maintenance

Completed NA Last updated 3 July 2024

What this trial tests

NA trial testing Mindfulness maintenance program in Depression in 34 participants. Completed in 19 February 2024.

Timeline

3 April 2023

Primary endpoint
19 February 2024

19 February 2024

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	3 April 2023
Primary completion	19 February 2024
Estimated completion	19 February 2024
Sites	1 location across United States

Drugs / interventions tested

• Mindfulness maintenance program

Conditions studied

• Depression — all drugs for Depression →

Sponsor

University of California, San Francisco

Who can join

18 and older, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Mindfulness-Based Cognitive Therapy (MBCT) combines meditation practices from Mindfulness-Based Stress Reduction (MBSR) with cognitive behavioral therapy to improve mental health. Although there is evidence that MBCT provides a variety of mental health benefits, it is particularly designed to prevent depression relapse, which occurs in 80% of people with a history of two episodes of depression. MBCT reduces depression relapse rates by 30%, on average after an eight-week course, and has lower relapse rates than continuing antidepressant medication. However, it is unknown what should be done following the program to optimize its long-term benefit. The investigators plan to conduct a pilot study in preparation for larger-scale clinical trial to determine the most effective maintenance approaches once MBCT has ended. The investigators gathered stakeholder input from MBCT graduates and MBCT teachers to inform the development of maintenance programs for MBCT. From this the investigators formulated several components of a maintenance program for MBCT. This includes providing a booster course for people who have already completed the MBCT program. This will be delivered as a 4-week course, meeting weekly, followed by monthly sessions to help participants build self-efficacy and agency with regard to creating their own plan for relapse prevention. This booster course is adapted from a 12-week program developed by Dr. Willem Kuyken at the Oxford Centre for Mindfulness. The team is planning the following sessions: 1 Deepening mindfulness with a focus on interoceptive awareness. 2) Hedonic system: Appreciating the light within. This would focus on positive emotion. 3) Responding not reacting 4) Two themes: taking care of ourselves, taking care of others. Integrating lessons into daily life with regards to sleep, diet, healthy relationships, behavioral activation. The study will also provide monthly follow-up sessions. The current study is a pilot study aimed at refining the intervention, providing initial data on acceptability and feasibility, and preliminary use of outcome measures in the context of the proposed study design.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Mindfulness-Based Cognitive Therapy for Depression, Taking It Further (MBCT-D-TiF): An Assessment of an Intervention Development Study.
   Siwik CJ, Harrison JM, Kuyken W, Segal Z, et al · · 2025 · PMID 41383293 · DOI 10.1177/27536130251407681