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Mood and Thought Process Study

Mood and Thought Process Study

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Description

Mindfulness-Based Cognitive Therapy (MBCT) is an efficacious treatment for patients with symptoms of depression. However, the processes by which MBCT achieves its outcomes are not well understood. Drawing on literature on basic cognitive functioning and cognitive biases in depression, this K23 will use a randomized controlled trial to test the effect of MBCT vs. Wellness for Wellbeing on affective inhibition (an important component of executive functioning (EF)), and a possible mechanism of action by which MBCT has an impact on depression symptoms. As a secondary aim, this project will also test the effect of MBCT vs. Wellness for Wellbeing on affective updating and affective shifting (two remaining components of EF). In exploratory analyses, the investigators will examine whether depression symptom severity covaries with change in affective EF (i.e., affective inhibition, shifting, and updating) overtime, and whether adherence to the treatment protocol predicts endpoint EF. To accomplish these goals, 76 adult participants with elevated depression symptoms will be recruited from the community and will be randomized to either an 8-week MBCT course at the Mindfulness Center at Brown University or an 8-week Wellness for Wellbeing Class. Participants will complete validated computer-based tasks of affective EF at 4-assessments, 1 before, 2 during, and 1 after, the 8-week MBCT or Wellness for Wellbeing programs.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

        Exclusion criteria include: (a) presence of psychotic symptoms that interfere with one's
        ability to function as determined by the SCID-5 Psychotic Screening Module; (b) current
        hazardous alcohol or drug use as indicated by a score of >10 for men and women on the AUDIT
        and the DUDIT for cannabis use, and >6 for men and women on the DUDIT for all other drugs
        (everything but cannabis), (c) change in psychiatric drug prescription within 4 weeks; (d)
        started psychotherapy or other psychiatric treatment within the past 4 weeks; (e) current
        suicide ideation or behavior which requires urgent intervention due to safety concerns; (f)
        Previous enrollment in MBCT or MBSR; (g) symptoms of mild cognitive impairment as indicated
        by a score of <26 on the MoCA; (h) formally diagnosed learning disability, intellectual
        disability, or other developmental disorder; (i) history of neurologic illness affecting
        cognition; (j) current symptoms indicative of a manic episode per the SCID-5 Mood Disorders
        Module.

Study details
    Depression in Remission
    Depressive Symptoms
    Depression

NCT05585775

Butler Hospital

28 January 2024

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