RecruitingNot ApplicableNCT05585775

Mood and Thought Process Study

Affective Executive Functioning as a Mechanism of Treatments for Depression Symptoms


Sponsor

Butler Hospital

Enrollment

76 participants

Start Date

Apr 6, 2023

Study Type

INTERVENTIONAL

Conditions

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. 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

Min Age: 18 Years

Inclusion Criteria13

  • 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

Interventions

BEHAVIORALMindfulness-Based Cognitive Therapy

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.

BEHAVIORALWellness for Wellbeing

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.


Locations(1)

Butler Hospital

Providence, Rhode Island, United States

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NCT05585775


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