Health TrialsbyHealthPanel

Mood and Thought Process Study

ConditionsDepression in RemissionDepressive SymptomsDepression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorButler Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Mindfulness-Based Cognitive Therapy (MBCT)Experimental treatment 1 intervention
Group B: Wellness for WellbeingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
10-week
2

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.

Time frame
10-week
3

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.

Time frame
10-week
4

Depression Symptoms

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

Time frame
10-week

Secondary outcomes

1

Attention Control Scale

Self-report measure of attention control

Time frame
10-week
2

Positive and Negative Affect Scale

Self-report measure of affect

Time frame
10-week
3

Five Factor Mindfulness Scale

Self-report measure of mindfulness

Time frame
10-week
4

Patient Health Questionnaire-9

Self-report measure of depression symptoms

Time frame
10-week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Butler Hospital

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Source ClinicalTrials.gov
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