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Treatment As Usual + Mindfulness Based Cognitive Therapy for Major Depressive Disorder

N/A
Waitlist Available
Led By Marasha De Jong, MD
Research Sponsored by Massachusetts General 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 baseline, week 4, week 8, 6 months, 12 months
Awards & highlights

Study Summary

The primary aim of this study is to test the feasibility and efficacy of Mindfulness Based Cognitive Therapy (MBCT) training for the treatment of depressive symptoms in patients with chronic pain. The study also aims to elucidate the mechanisms underlying MBCT on a psychological and neurobiological level. For this purpose the study subjects will fill out several psychological questionnaires related to mindfulness, depression and chronic pain. Moreover this study involves optional fMRI scans of the brain and blood measures before and after the intervention. Main hypotheses: The MBCT training will be a feasible intervention in patients with chronic pain and co-morbid depression as defined by no occurrence of serious adverse events related to the intervention and a retention rate of more than 70% in the subjects assigned to the MBCT arm. Patients who have completed the MBCT training will demonstrate a significant decrease in depressive symptoms as measured on the Quick Inventory of Depressive Symptomatology - Clinician rated (QIDS-C16), and the Hamilton Rating Scale for Depression (HRSD17) (QIDS-C/HRDS) severity scale for depressive symptoms (the primary outcome measure), compared to the control group.

Eligible Conditions
  • Major Depressive Disorder
  • Chronic Pain
  • Dysthymia
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4, week 8, 6 months, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4, week 8, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline on the combined Quick Inventory of Depressive Symptomatology-clinician rated and the Hamilton Rating Scale for Depression (QIDS-C16/HRDS17), at week 8.
Secondary outcome measures
Response according to Brief Pain Inventory (BPI-sf).
Response according to Short Form Health Survey, 36 items (SF-36).
Response according to the Beck Anxiety Inventory, 21 items (BAI).

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment As Usual + Mindfulness Based Cognitive TherapyExperimental Treatment1 Intervention
Subjects randomized into the intervention group will receive, a manualized 8-week MBCT group skills program with sessions that each last 2 hours, in addition to their treatment as usual (TAU).
Group II: Treatment As UsualActive Control1 Intervention
Patients randomized into the TAU group will continue to receive their care as usual and be put on a waitlist. They will be offered the MBCT treatment after the completion of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness Based Cognitive Therapy
2014
Completed Phase 4
~2080

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,295 Total Patients Enrolled
Marasha De Jong, MDPrincipal InvestigatorMasachusetts General Hospital
Heidi Ashih, MD, PhDPrincipal InvestigatorMassachusetts General Hospital

Frequently Asked Questions

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~4 spots leftby Apr 2025