Depression in RemissionMAT ProcessNCT05585775
Mood and Thought Process Study
A study testing Mindfulness-Based Cognitive Therapy and Wellness for Wellbeing in people with Depression in Remission and Depressive Symptoms, run by Butler Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression in Remission, Depressive Symptoms, Depression
- What is being tested?
- Mindfulness-Based Cognitive Therapy and Wellness for Wellbeing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2023to 4 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Affective Executive Functioning as a Mechanism of Treatments for Depression Symptoms
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:
- 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.
- 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.
Read more
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.
Read the 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.
- Conditions
- Depression in Remission, Depressive Symptoms, Depression
- Being tested
- Mindfulness-Based Cognitive Therapy, Wellness for Wellbeing
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive TherapyBehavioural
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 WellbeingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Wellness for Wellbeing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 10-week
Depression Symptoms
Participants will complete the 16-item Quick Inventory of Depression Symptoms (Self-Report) measure assessing depression symptoms and associated symptoms.
Measured: 10-week
Secondary outcomes (6)
Attention Control Scale
Self-report measure of attention control
Measured: 10-week
Positive and Negative Affect Scale
Self-report measure of affect
Measured: 10-week
Five Factor Mindfulness Scale
Self-report measure of mindfulness
Measured: 10-week
Patient Health Questionnaire-9
Self-report measure of depression symptoms
Measured: 10-week
Ruminative Response Scale
Self-report measure of rumination
Measured: 10-week
Generalized Anxiety Disorder -7
Self-report measure of anxiety symptoms
Measured: 10-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start6 Apr 2023
- Primary completion4 Sep 2026
- Study completion4 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in RemissionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Morganne Kraines, Butler Hospital
- Investigators
- Morganne Kraines, PhD, Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585775
- Sponsor's protocol ID
- 2110-001
- Other IDs
- K23AT011388-01A1
- Acronym
- MAT Process
- Status last verified
- Sep 2026
- First submitted
- 11 Oct 2022
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Because data from this project will be completely de-identified and our sample will not be easily identifiable, data will be made available upon request to other researchers without cost to researchers or analysts.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affective Executive Functioning as a Mechanism of Treatments for Depression Symptoms
- ClinicalTrials.gov ID
- NCT05585775
- Acronym / sponsor ID
- MAT Process / 2110-001
- Conditions
- Depression in Remission, Depressive Symptoms, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 4 Sep 2026 (actual)
- Study completion
- 4 Sep 2026 (actual)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Cognitive Therapy (MBCT) | Experimental | Behavioral: Mindfulness-Based Cognitive TherapyMBCT 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 | Active comparator | Behavioral: Wellness for WellbeingWellness 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Cognitive TherapyMBCT 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. | Behavioural | Mindfulness-Based Cognitive Therapy (MBCT) |
| Wellness for WellbeingWellness 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. | Behavioural | Wellness for Wellbeing |
Primary outcome
Affective Go/No-Go
Time frame: 10-week
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.
Emotional n-back
Time frame: 10-week
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.
Affective Internal Switching Task
Time frame: 10-week
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.
Depression Symptoms
Time frame: 10-week
Participants will complete the 16-item Quick Inventory of Depression Symptoms (Self-Report) measure assessing depression symptoms and associated symptoms.
6 secondary outcomes
Attention Control Scale
Time frame: 10-week
Positive and Negative Affect Scale
Time frame: 10-week
Five Factor Mindfulness Scale
Time frame: 10-week
Patient Health Questionnaire-9
Time frame: 10-week
Ruminative Response Scale
Time frame: 10-week
Generalized Anxiety Disorder -7
Time frame: 10-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: Yes. Because data from this project will be completely de-identified and our sample will not be easily identifiable, data will be made available upon request to other researchers without cost to researchers or analysts.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morganne Kraines, PhD principal investigator
Butler Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Cognitive Therapy and Wellness for Wellbeing in people with Depression in Remission and Depressive Symptoms, run by Butler Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Affective Go/No-Go (time frame: 10-week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.