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Behavioral Intervention
Mindfulness-Based Therapy for Depression (MAT Process Trial)
N/A
Recruiting
Led By Morganne Kraines, PhD
Research Sponsored by Butler Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10-week
Awards & highlights
MAT Process Trial Summary
This trial aims to investigate whether Mindfulness-Based Cognitive Therapy or Wellness for Wellbeing can affect emotions by testing their effect on inhibition, updating & shifting. Participants will take surveys, interviews & computer tasks.
Who is the study for?
This trial is for English-speaking adults (18+) with mild to moderate depression, who have had a major depressive episode in the last 5 years but are not currently experiencing severe symptoms or a major episode. Participants should not be undergoing recent changes in psychotherapy or medication, and must not have prior mindfulness-based treatment experience.Check my eligibility
What is being tested?
The study compares Mindfulness-Based Cognitive Therapy (MBCT) with Wellness for Wellbeing to see how they affect mood and thought processes related to emotions. It uses random assignment to either intervention and measures outcomes through tasks that assess emotional control like inhibition, updating, and shifting.See study design
What are the potential side effects?
Since this trial involves psychological therapies rather than medications, side effects may include temporary increases in emotional discomfort as participants engage with their thoughts and feelings during therapy sessions.
MAT Process Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10-week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10-week
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Affective Go/No-Go
Affective Internal Switching Task
Depression Symptoms
+1 moreSecondary outcome measures
Attention Control Scale
Five Factor Mindfulness Scale
Generalized Anxiety Disorder -7
+3 moreMAT Process Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness-Based Cognitive Therapy (MBCT)Experimental Treatment1 Intervention
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.
Group II: Wellness for WellbeingActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness-Based Cognitive Therapy
2013
Completed Phase 2
~5470
Find a Location
Who is running the clinical trial?
Butler HospitalLead Sponsor
130 Previous Clinical Trials
16,417 Total Patients Enrolled
31 Trials studying Depression
6,313 Patients Enrolled for Depression
National Center for Complementary and Integrative Health (NCCIH)NIH
837 Previous Clinical Trials
669,713 Total Patients Enrolled
61 Trials studying Depression
32,839 Patients Enrolled for Depression
Morganne Kraines, PhDPrincipal InvestigatorButler Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not experiencing symptoms of a manic episode.My psychiatric medication has not changed in the last 4 weeks.I do not have symptoms like hallucinations or delusions that affect my daily life.I have never participated in mindfulness-based stress reduction or cognitive therapy.I am 18 years old or older.I started mental health treatment in the last month.My vision is normal, or I wear glasses/contacts to correct it.I have no history of brain disorders that affect my thinking.My psychotherapy treatment has been stable for at least 4 weeks.I am currently experiencing symptoms of a manic episode.My psychiatric medications have been stable for at least 4 weeks.I have mild memory or thinking problems.You have symptoms of depression that are not severe, but still higher than normal.I am not currently experiencing a major depressive episode.I have had a major depressive episode in the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Wellness for Wellbeing
- Group 2: Mindfulness-Based Cognitive Therapy (MBCT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT05585775 — N/A
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