Optimizing Mindfulness Based Cognitive Therapy (MBCT) Maintenance

NCT05859386 | Completed

• 1 other identifier: 22-37109
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Keywords

depression; mindfulness

Outcome Measures

Primary Outcomes (1)

• Client Satisfaction Scale (CSQ) scores

  Self-assessed satisfaction with care will be measured using the CSQ questionnaire. Scores on the 1979 version of the CSQ questionnaire range from 8 to 32, with higher scores indicating higher levels of satisfaction.

  4 months

Secondary Outcomes (5)

• Client Satisfaction Scale (CSQ) scores

  1 month

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 8a scores

  Baseline to 4 months change

• Change in Experiences Questionnaire scores

  Baseline to 4 months change

• Change in Five Facet Mindfulness Questionnaire-short form (FFMQ-sf) scores

  Baseline to 4 months change

• Change in Self-Compassion Scale-Short Form (SCS-sf) scores

  Baseline to 4 months change

Study Arms (2)

Mindfulness maintenance program

EXPERIMENTAL

Participants receive: (1) Four-week course to strengthen and extend skills learned in 8-week MBCT course, (2) Monthly 1.5 hour meeting session, and (3) Monthly check-in survey.

Behavioral: Mindfulness maintenance program

Wait-list

NO INTERVENTION

Participants receive follow-up measures but no intervention until the end of the wait-list period.

Interventions

Mindfulness maintenance program BEHAVIORAL

1. Four-week course to strengthen and extend skills learned in 8-week MBCT course. This will consist of four 2-hour sessions, occurring weekly for four weeks. 2. Monthly 1.5 hour meeting sessions. These will be led by an experienced MBCT teacher and will consist of a group meditation practice, a check-in time, and discussion of a topic relevant to the MBSR course. 3. Monthly check-in survey. This will be a brief (5 - 10 minute) survey (using Qualtrics) with questions about mood (PROMIS Depression and Positive Affect scales) and recent meditation practice.

Mindfulness maintenance program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18+
• Previously completed MBCT program.
• A main reason (per self-report) for taking MBCT was for depression
• \. Have smartphone or other device for attending virtual classes 6. Ability to speak and read English 7. Lives in US

You may not qualify if:

• Patient Health Questionnaire 8 (PHQ8) score \>14 or 5+ items endorsed "more than half the days" or more, one of which corresponds to Question #1 or #2 (generally regarded as indicative of current Major Depressive Disorder).
• High current risk of suicide on Columbia-Suicide Severity Rating Scale (CSSR-S) or history of attempt in past year
• Unable or unwilling to attend Zoom group-based sessions as scheduled
• History of Bipolar 1 disorder, Psychosis or Schizophrenia, or Borderline Personality disorder
• Substance use, mental health, or other condition that in the opinion of the investigators will make participation in a group setting difficult.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Mental Insight Foundation: collaborator

Study Sites (1)

UCSF

San Francisco, California, 94143-1726, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Frederick Hecht, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The first group will be a single group aimed at initial intervention refinement. The second group will be randomized to either receive the intervention or enter a wait-list control condition.

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 16, 2023
• Study Start: April 3, 2023
• Primary Completion: February 19, 2024
• Study Completion: February 19, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)