Practicing Alternative Techniques to Heal From Depression: The PATH-D Study
PATH-D
Applying Mindfulness-Based Cognitive Therapy to Treatment Resistant Depression
3 other identifiers
interventional
173
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable major-depressive-disorder
Started Sep 2009
Longer than P75 for not_applicable major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2009
CompletedFirst Posted
Study publicly available on registry
March 30, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedDecember 2, 2014
December 1, 2014
4.8 years
March 27, 2009
December 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hamilton Depression Rating Scale (HAMD-17)
Baseline, 4, 8, 24, 36, 52 week
Secondary Outcomes (5)
Quick Inventory of Depressive Symptomatology(Self-Rated)-16 items(QIDS-SR16)
Baseline, weeks 1-8, 24, 36, 52 week
Short Form Health Survey-36
Baseline, 8, 24, 36, 52 week
Clinical Global Improvement Scale (CGI)
Baseline, 8, 24, 36, 52 weeks
Work and Social Activity Scale (WSAS)
Baseline, 8, 24,36,52 weeks
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (QLESQ-SF)
Baseline, 8, 24, 36, 52 weeks
Study Arms (2)
1
EXPERIMENTALMindfulness Based Cognitive Therapy (MBCT) + medication management
2
ACTIVE COMPARATORThe Health Enhancement Program (HEP) + medication management
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
Related Publications (7)
HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
PMID: 14399272BACKGROUNDRush AJ, Trivedi M, Fava M. Depression, IV: STAR*D treatment trial for depression. Am J Psychiatry. 2003 Feb;160(2):237. doi: 10.1176/appi.ajp.160.2.237. No abstract available.
PMID: 12562566BACKGROUNDRush AJ, Trivedi MH, Wisniewski SR, Stewart JW, Nierenberg AA, Thase ME, Ritz L, Biggs MM, Warden D, Luther JF, Shores-Wilson K, Niederehe G, Fava M; STAR*D Study Team. Bupropion-SR, sertraline, or venlafaxine-XR after failure of SSRIs for depression. N Engl J Med. 2006 Mar 23;354(12):1231-42. doi: 10.1056/NEJMoa052963.
PMID: 16554525BACKGROUNDWare J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
PMID: 8628042BACKGROUNDMundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
PMID: 11983645BACKGROUNDEndicott J, Nee J, Harrison W, Blumenthal R. Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993;29(2):321-6.
PMID: 8290681BACKGROUNDEisendrath SJ, Gillung EP, Delucchi KL, Chartier M, Mathalon DH, Sullivan JC, Segal ZV, Feldman MD. Mindfulness-based cognitive therapy (MBCT) versus the health-enhancement program (HEP) for adults with treatment-resistant depression: a randomized control trial study protocol. BMC Complement Altern Med. 2014 Mar 11;14:95. doi: 10.1186/1472-6882-14-95.
PMID: 24612825DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stuart J Eisendrath, MD
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2009
First Posted
March 30, 2009
Study Start
September 1, 2009
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
December 2, 2014
Record last verified: 2014-12