NCT07069361

Brief Summary

This randomized controlled trial investigates the effects of an 8-week mindfulness-based interventions, Mindfulness for Life (MBCT-L) on daily emotion regulation, psychological functioning, and work-related outcomes. The primary objective of this study is to investigate the underlying mechanism of change between mindfulness and job performance and satisfaction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

July 30, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2025

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

July 7, 2025

Last Update Submit

December 31, 2025

Conditions

Keywords

MindfulnessMindfulness for LifeInterventionEmotion RegulationOrganizational OutcomesRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Multidimensional State Mindfulness Questionnaire (MSMQ)

    This scale is used to measure daily changes in state mindfulness. Participants will self-report levels of acting with awareness, nonjudgemental acceptance and present-moment attention in the context of their work day. The Multidimensional State Mindfulness Questionnaire (MSMQ) includes 9 items, rated on a Likert-type scale, and is designed to capture mindfulness as it fluctuates over time. Data will be collected across three daily diary periods: a baseline period before any intervention, a second period following the first 8-week phase, and a final period conducted after the second 8-week phase, once the crossover is complete. This structure allows for the examination of both between-group and within-subject changes in state mindfulness associated with the intervention.

    Baseline (pre-intervention), week 8 (post-first phase), and week 16 (end of study following crossover).

Secondary Outcomes (9)

  • Metacognitive Processes of Decentering - State Scale (MPoD-s)

    Baseline (pre-intervention), week 8 (post-first phase), and week 16 (end of study following crossover)

  • Positive Reframing

    Baseline (pre-intervention), week 8 (post-first phase), and week 16 (end of study following crossover)

  • Positive and Negative Affect Schedule - Short Form (PANAS-SF)

    Baseline (pre-intervention), week 8 (post-first phase), and week 16 (end of study following crossover).

  • Psychological Capital

    Baseline (pre-intervention), week 8 (post-first phase), and week 16 (end of study following crossover)

  • In-Role Job Performance

    Baseline (pre-intervention), week 8 (post-first phase), and week 16 (end of study following crossover)

  • +4 more secondary outcomes

Study Arms (4)

Mindfulness-Based Cognitive Therapy - Life Course Adaptation (MBCT-L)

EXPERIMENTAL

Mindfulness For Life (MBCT-L) is an adapted version of Mindfulness-Based Cognitive Therapy, designed for the general population. While rooted in the original MBCT program, which was developed for preventing depressive relapse, Mindfulness for Life is tailored to increase the levels of psychological well-being, emotional resilience and mental health outcomes in non-clinical populations. The program consist of 8 weekly sessions of 2 hours and 15 minutes, complemented by guide daily home practice. Participants are taught mindfulness meditation practices, cognitive-behavioral strategies, and experiential exercises aimed at enhancing self-awareness and emotional regulation. The intervention follows the standardized 'Mindfulness for Life' curriculum, as developed by the Oxford Mindfulness Foundation (OMF), and is delivered by an instructor trained in the approach through OMF.

Behavioral: Mindfulness-Based Cognitive Therapy - Life Course Adaptation (MBCT-L)

Wait-List Control Group

NO INTERVENTION

Participants in the wait-list control group will not receive the intervention during the initial study period but will be offered access to the Mindfulness for Life (MBCT-L) program after the initial phase of the study ends. For the first 8 weeks, they will not receive any structured psychological intervention as part of the study. They will continue any usual care or personal routines, an they will complete the same assements at equivalent time points. After this initial waiting period and completion of the first follow-up assessment, participants will then begin the Mindfulness for Life (MBCT-L) program.

Wait-List Control Group Phase 2

NO INTERVENTION

This is the second phase of a two-period crossover study. During this phase, participants assigned to the wait-list control condition do not receive any psychological intervention or active treatment. They continue with their usual activities and complete outcome assessments. In Phase 1 of the trial, the participants assigned to this group received the MBCT-L interventions.

Mindfulness for Life - Mindfulness- Based Cognitive Therapy Adaptation (MBCT-L) Phase 2

EXPERIMENTAL

This is the second phase of a two-period crossover study. During this phase, participants who were originally assigned to the wait-list control group now receive the MBCT-L intervention.

Behavioral: Mindfulness-Based Cognitive Therapy - Life Course Adaptation (MBCT-L)

Interventions

MBCT-L (Mindfulness-Based Cognitive Therapy for Life) Is a structered, group-based intervention developed for use with healthy adults. The programs runs for 8 consecutive weeks, with sessions lasting 2 hours and 15 minutes. It includes formal and informal mindfulness practices, exercises to develop cognitive and emotion awareness, with elements adapted from cognitive therapy. The course was designed to support participants in cultivating habits that increase emotion regulation and psychological well-being. Home practice is assigned daily using audio-guided meditations. The intervention is standardized and delivered by a instructor trained under Oxford Mindfulness Centre (OMC) protocols. MBCT-L is distinct from the clinical MBCT model used for relapse prevention. And it is also disting from other Mindfulness-Based interventions as it uses different exercises than, for example, Mindfulness-Based Stress Reduction which emphasis stress theories in the intervention.

Mindfulness for Life - Mindfulness- Based Cognitive Therapy Adaptation (MBCT-L) Phase 2Mindfulness-Based Cognitive Therapy - Life Course Adaptation (MBCT-L)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 65 years
  • Full-time Workers

You may not qualify if:

  • Experiencing Hallucinations
  • Experiencing psychotic symptoms
  • Recieving psychotropic medications
  • Experiencing legal or health issues that would prevent them to attend the sessions.
  • Have had participated in a Mindfulness-Based course in the last 2 years.
  • Presenting symptoms of intellectual disability, communication disorders or neurocognitive disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bucharest

Bucharest, Sector 5, 050663, Romania

Location

Related Publications (2)

  • Hanley AW, de Vibe M, Solhaug I, Farb N, Goldin PR, Gross JJ, Garland EL. Modeling the mindfulness-to-meaning theory's mindful reappraisal hypothesis: Replication with longitudinal data from a randomized controlled study. Stress Health. 2021 Oct;37(4):778-789. doi: 10.1002/smi.3035. Epub 2021 Mar 9.

    PMID: 33607697BACKGROUND
  • Wang Y, Garland EL, Farb NAS. An experimental test of the mindfulness-to-meaning theory: Casual pathways between decentering, reappraisal, and well-being. Emotion. 2023 Dec;23(8):2243-2258. doi: 10.1037/emo0001252. Epub 2023 May 11.

    PMID: 37166828BACKGROUND

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: This study uses a two-period crossover design. Participants are randomly assigned to one of two sequences: (1) immediate intervention with Mindfulness-Based Cognitive Therapy for Life (MBCT-L) followed by a no-treatment follow-up period, or (2) initial wait-list control with no intervention followed by MBCT-L. Each phase lasts 8 weeks, with outcome assessments conducted at the end of each phase. The baseline measurement preintervention is in the week preceding the start of the first phase of the study.This design allows for both between-group comparisons during the first phase and within-subject comparisons across the two phases.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychology

Study Record Dates

First Submitted

July 7, 2025

First Posted

July 16, 2025

Study Start

July 30, 2025

Primary Completion

December 12, 2025

Study Completion

December 12, 2025

Last Updated

January 2, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
1 January 2026 to 1 January 2031

Locations