Clinical trial NCT05585775: Mood and Thought Process Study
Official title: Affective Executive Functioning As a Mechanism of Treatments for Depression Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression in Remission
Depressive Symptoms
Depression
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2022-10-19
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

Detailed 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 criteria: 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.

Primary outcomes:
measure: Affective Go/No-Go
timeFrame: 10-week
measure: Emotional n-back
timeFrame: 10-week
measure: Affective Internal Switching Task
timeFrame: 10-week
measure: Depression Symptoms
timeFrame: 10-week
Secondary outcomes:
measure: Attention Control Scale
timeFrame: 10-week
measure: Positive and Negative Affect Scale
timeFrame: 10-week
measure: Five Factor Mindfulness Scale
timeFrame: 10-week
measure: Patient Health Questionnaire-9
timeFrame: 10-week
measure: Ruminative Response Scale
timeFrame: 10-week
measure: Generalized Anxiety Disorder -7
timeFrame: 10-week
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Morganne Kraines, PhD
role: PRINCIPAL_INVESTIGATOR
References: