Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05585775

Mood and Thought Process Study

Led by Butler Hospital · Updated on 2025-11-05

76

Participants Needed

1

Research Sites

195 weeks

Total Duration

On this page

Sponsors

B

Butler Hospital

Lead Sponsor

N

National Center for Complementary and Integrative Health (NCCIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The primary objective for this project is to test whether affective executive functioning is a mechanism of action of mindfulness-based cognitive therapy and Wellness for Wellbeing. The main questions it aims to answer are: 1. Test the effect of MBCT vs. Wellness for Wellbeing on affective inhibition (i.e., emotionally valenced inhibition as measured via the affective Go/No Go task) using an RCT. 2. Test the effect of MBCT vs. Wellness for Wellbeing on (a) affective updating and (b) affective shifting. Outcomes will be measured with the affective n-Back and the affective Internal Switching Task, respectively. 3a) The investigators will examine whether depression symptom severity co-varies with change in affective executive functioning (i.e., affecting inhibition, shifting, and updating) over time. 3b) The investigators will examine whether compliance with treatment protocol (e.g., number of classes attended, amount of home practice) predicts endpoint executive functioning. Participants will complete surveys, interviews, and computer tasks, and will be randomized to either Mindfulness-Based Cognitive Therapy or Wellness for Wellbeing.

CONDITIONS

Official Title

Mood and Thought Process Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years or older
  • Fluent in English to complete study procedures
  • Normal vision or corrected to normal vision
  • QIDS score between 5 and 15 indicating elevated but not severe depression symptoms
  • No psychotic symptoms interfering with functioning
  • No current hazardous alcohol or drug use
  • No prior experience with mindfulness-based treatment (MBCT or MBSR)
  • No current symptoms of mania indicating a manic episode
  • No current cognitive impairment
  • No history of diagnosed learning disability, intellectual disability, or developmental disorder
  • No history of neurological illness affecting cognition
  • No change in psychiatric medications for at least 4 weeks if medicated
  • No change in psychotherapy status for at least 4 weeks if in therapy
Not Eligible

You will not qualify if you...

  • Presence of psychotic symptoms interfering with functioning
  • Current hazardous alcohol or drug use above defined thresholds
  • Change in psychiatric drug prescription within the past 4 weeks
  • Started psychotherapy or psychiatric treatment within the past 4 weeks
  • Current suicidal thoughts or behaviors requiring urgent intervention
  • Previous enrollment in MBCT or MBSR
  • Symptoms of mild cognitive impairment (MoCA score below 26)
  • Diagnosed learning disability, intellectual disability, or developmental disorder
  • History of neurological illness affecting cognition
  • Current symptoms indicative of a manic episode

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Butler Hospital

Providence, Rhode Island, United States, 02906

Actively Recruiting

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Research Team

M

Morganne Kraines, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Mood and Thought Process Study | DecenTrialz