Mood and Thought Process Study

NCT05585775 | Recruiting DMC

• 2 other identifiers: 2110-001K23AT011388-01A1
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.

Conditions

Depression in Remission; Depressive Symptoms; Depression

Outcome Measures

Primary Outcomes (4)

• Affective Go/No-Go

  This task requires utilizing inhibition to respond to word features (i.e., normal vs. italicized font) rather than word content. In this task, participants are told to respond (via key press) when a go stimulus (i.e., normal text) is presented and to withhold their response when a no-go stimulus (i.e., italicized text) is presented. words are negatively valenced (e.g., hate, sad) or positively valenced (e.g., terrific, win). Conditions are matched on word length and frequency of use in the English language.

  10-week

• Emotional n-back

  Updating will be measured via the n-Back Task. Individuals are presented words on a computer screen, and are asked to indicate (via key press), whether the current word is the same or different from the word presented n times back. The investigators will be using 2-back trials, as these trials are not too difficult so that participants become frustrated, yet engage updating processes. The affective version of the task will be an adapted affective n-back task in which individuals are presented with negative and positive words, and asked to indicate via key press whether the word n-trials back matches the valence (positive or negative) of the current word.

  10-week

• Affective Internal Switching Task

  Shifting will be measured via the Internal Switching Task (IST). Participants are presented with one word on the computer screen at a time, and are asked to keep a silent mental count of how many words they see from two semantic categories (i.e., positive affective words and negative affective words). Participants are instructed to press the spacebar when they have updated their mental count and are ready for the next word. Participants are asked to keep a mental count of how many positive and how many negative words appear in each category, and press the spacebar when they have updated their mental count.

  10-week

• Depression Symptoms

  Participants will complete the 16-item Quick Inventory of Depression Symptoms (Self-Report) measure assessing depression symptoms and associated symptoms.

  10-week

Secondary Outcomes (6)

• Attention Control Scale

  10-week

• Positive and Negative Affect Scale

  10-week

• Five Factor Mindfulness Scale

  10-week

• Patient Health Questionnaire-9

  10-week

• Ruminative Response Scale

  10-week

Study Arms (2)

Mindfulness-Based Cognitive Therapy (MBCT)

EXPERIMENTAL

MBCT classes are comprised of weekly, 2.5-hour classes in which participants learn cognitive therapy techniques and practice meditation exercises. Participants will complete group and/or individual orientation to MBCT with the MBCT instructor, 1-2 weeks prior to the first scheduled MBCT class. Additionally, MBCT requires 45-minutes of daily home practice, and a full day, 8-hour silent meditation retreat. MBCT classes are delivered via the protocol and curriculum developed by the MBCT founders. Participants randomized to MBCT will receive 8-weeks of MBCT classes.

Behavioral: Mindfulness-Based Cognitive Therapy

Wellness for Wellbeing

ACTIVE COMPARATOR

Wellness for Wellbeing will serve as the active control for MBCT. Participants randomized to Wellness for Wellbeing will receive 1-hour group delivered classes, once per week, for 8-weeks. Participants will receive an orientation to Wellness for Wellbeing 1-2 weeks prior to the first class. Classes will be delivered by a research therapist. Topics for Wellness for Wellbeing include: nutrition, caffeine, preventing cancer, diabetes, heart health, sleep, being a smart patient, and complementary and alternative medicine. Wellness for Wellbeing classes are interactive and do not include components designed to impact affective cognition in any way. Because participants may have varying levels of health literacy, the research therapist tailors presentation of the material to the participants' level of knowledge of the topic. Information presented in Wellness for Wellbeing is regularly updated with current health guidelines.

Behavioral: Wellness for Wellbeing

Interventions

Mindfulness-Based Cognitive Therapy BEHAVIORAL

MBCT classes are comprised of weekly, 2.5-hour classes in which participants learn cognitive therapy techniques and practice meditation exercises. Participants will complete group and/or individual orientation to MBCT with the MBCT instructor, 1-2 weeks prior to the first scheduled MBCT class. Additionally, MBCT requires 45-minutes of daily home practice, and a full day, 8-hour silent meditation retreat. MBCT classes are delivered via the protocol and curriculum developed by the MBCT founders. Participants randomized to MBCT will receive 8-weeks of MBCT classes.

Mindfulness-Based Cognitive Therapy (MBCT)

Wellness for Wellbeing BEHAVIORAL

Wellness for Wellbeing will serve as the active control for MBCT. Participants randomized to Wellness for Wellbeing will receive 1-hour group delivered classes, once per week, for 8-weeks. Participants will receive an orientation to Wellness for Wellbeing 1-2 weeks prior to the first class. Classes will be delivered by a research therapist. Topics for Wellness for Wellbeing include: nutrition, caffeine, preventing cancer, diabetes, heart health, sleep, being a smart patient, and complementary and alternative medicine. Wellness for Wellbeing classes are interactive and do not include components designed to impact affective cognition in any way. Because participants may have varying levels of health literacy, the research therapist tailors presentation of the material to the participants' level of knowledge of the topic. Information presented in Wellness for Wellbeing is regularly updated with current health guidelines.

Wellness for Wellbeing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 years or older
• English fluency in order to complete study procedures
• Normal vision or corrected to normal vision
• QIDS score ≥ 5 and ≤ 15 to include individuals with elevated, but not severe symptoms of depression
• No presence of psychotic symptoms that interfere with functioning
• No current hazardous alcohol or drug use
• No previous experience with mindfulness-based treatment (i.e., enrollment in MBSR or MBCT previously)
• No current symptoms of mania indicative of a manic episode
• No current cognitive impairment
• No history of a formally diagnosed learning disability in reading, intellectual disability or other developmental disorder
• No history of a neurologic illness affecting cognition
• If on psychiatric medications, no change in medications for at least 4 weeks
• If in psychotherapy, no change in therapy status for at least 4 weeks

Sponsors & Collaborators

• Butler Hospital: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Mindfulness-Based Cognitive Therapy; Health

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Population Characteristics

Study Officials

• Morganne Kraines, PhD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Morganne Kraines, PhD

CONTACT

401-455-6626; MKraines@carene.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychologist

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 19, 2022
• Study Start: April 6, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)