Mood and Thought Process Study (NCT05585775) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Mood and Thought Process Study
United States76 participantsStarted 2023-04-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is measuring things like emotional reaction tasks and thought-switching tests rather than testing a new treatment — so what would actually be gained for me personally by participating, since it sounds more like a research observation study than something offering a new therapy?
2The trial is listed as 'active, not recruiting,' which means they're no longer taking new participants — is there any chance my doctor knows of a similar study on mood and cognitive processing that is currently open to enrollment?
3Since the study involves tasks measuring how I process emotions and switch between thoughts, could participating in these kinds of assessments cause any psychological distress, and is that something my care team should monitor for?
4This study seems to be looking at people both in remission from depression and with current depressive symptoms — given where I am in my own depression right now, would my doctor think this type of cognitive research study is appropriate for my current mental health situation?
5Because this is a non-treatment observational study focused on thought processes and mood, would my doctor recommend I focus my energy on standard treatment options first, or could participating in something like this complement my current care plan??
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.