University of California, San Francisco
San Francisco, California, 94143, United States
NCT Number: NCT00871299
This study is a randomized, controlled trial of Mindfulness-Based Cognitive Therapy (MBCT) versus Health-Enhancement Program (HEP) for patients with treatment-resistant major depressive disorder (MDD). Both arms of the study will continue to receive the standard medication management treatment as usual (TAU) throughout the study. MBCT is a new technique that has been found to be effective for prevention of relapse in individuals in complete recovery from depression. MBCT is a group-based, 8-week intervention that uses mindfulness meditation as its core therapeutic ingredient. It teaches people to have a different relationship to depressive thoughts and feelings. This study will use an active condition called the Health Enhancement Program (HEP) which was specifically developed to serve as a comparison condition for mindfulness interventions. HEP has been shown to decrease global stress levels and to increase perceived health. Stress has been considered a contributor to depression. One hundred and seventy four patients with MDD who have failed two or more adequate antidepressant trials will be identified and randomly assigned to one of two groups: MBCT+TAU or HEP+TAU. All patients who enroll in the study will undergo follow-up assessments at 3, 6, 9 and 12 months following the intervention. A supplemental portion of the study will enroll 88 patients to undergo functional magnetic resonance imagining (fMRI) scans immediately before and after treatment to better understand the neural pathways implicated in depression and those that may be affected through treatment.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
San Francisco, California, 94143, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
DSM-IV TR Diagnosis of Major Depression receiving medication management.
Adequate trial of 2 or more antidepressants (ATHF) for a minimum of 6 weeks (one of which at UCSF).
Hamilton Depression Rating Scale 17 score ≥ 14
Any Ethnicity
English Speaking
Male or Female
No current psychotherapy (i.e. only medication management treatment) or plan to start new psychotherapy during MBCT or HEP
Exclusion criteria
Bipolar Disorder, Obsessive Compulsive Disorder, Schizophrenia, Schizoaffective Disorder, Antisocial and Borderline Personality Disorders, Current Eating Disorder, Pervasive Development Delay Major Depression with Psychotic Features
Active Suicidality (per HAM-D17 > 1 on item 3)
Meditation Practice once or more per week; yoga more than twice per week at study entry
Substance Abuse Disorder within 6 months
Cognitive Disorder with Mini Mental Status Exam score < 25
Medical illness rated 4 on Cumulative Illness Rating Scale
Mindfulness-Based Cognitive Therapy (MBCT) is a group treatment that integrates mindfulness meditation training with some CBT concepts and was specifically developed as a relapse prevention intervention for MDD. The program teaches skills that allow patients to disengage from habitual ("automatic") dysfunctional cognitive routines, in particular depression-related ruminative thought patterns, as a way to reduce future risk of relapse and recurrence of depression.
The Health Enhancement Program (HEP)was developed at the University of Wisconsin, Madison and is modeled after traditional activity and nutrition programs used in weight management- cardiac rehab and diabetes prevention programs. The program is designed to increase overall health and well-being by focusing on four health domains that impact health and are interventions regularly practiced at integrative medicine. These include: (I) Music Therapy (2) Nutrition (3) physical activity including, walking and stretching and (4) Functional movement.
Time frame: Baseline, 4, 8, 24, 36, 52 week
Time frame: Baseline, weeks 1-8, 24, 36, 52 week
Time frame: Baseline, 8, 24, 36, 52 week
Time frame: Baseline, 8, 24, 36, 52 weeks
Time frame: Baseline, 8, 24,36,52 weeks
Time frame: Baseline, 8, 24, 36, 52 weeks
University of California, San Francisco
Other
Applying Mindfulness-Based Cognitive Therapy to Treatment Resistant Depression
Acronym: PATH-D
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06230757
Anhedonia, Depressive Disorder
Aurora, Colorado, United States
View Trial DetailsNCT05615948
Agnosia, Analgesia
Brooklyn, New York, United States
View Trial DetailsNCT06655623
Behavior, Behavioral Symptoms
Copenhagen, Denmark
View Trial DetailsNCT06730841
Depressive Disorder, Depressive Disorder, Major
San Diego, California, United States
View Trial Details