Clinical trial NCT00871299: Practicing Alternative Techniques to Heal From Depression: The PATH-D Study
Official title: Applying Mindfulness-Based Cognitive Therapy to Treatment Resistant Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Treatment-resistant depression, meditation, mindfulness
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2009-03-30
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hamilton Depression Rating Scale (HAMD-17)
timeFrame: Baseline, 4, 8, 24, 36, 52 week
Secondary outcomes:
measure: Quick Inventory of Depressive Symptomatology(Self-Rated)-16 items(QIDS-SR16)
timeFrame: Baseline, weeks 1-8, 24, 36, 52 week
measure: Short Form Health Survey-36
timeFrame: Baseline, 8, 24, 36, 52 week
measure: Clinical Global Improvement Scale (CGI)
timeFrame: Baseline, 8, 24, 36, 52 weeks
measure: Work and Social Activity Scale (WSAS)
timeFrame: Baseline, 8, 24,36,52 weeks
measure: Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (QLESQ-SF)
timeFrame: Baseline, 8, 24, 36, 52 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Stuart J Eisendrath, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Rush 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.
citation: Rush 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.
citation: Ware 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.
citation: Mundt 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.
citation: Endicott J, Nee J, Harrison W, Blumenthal R. Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993;29(2):321-6.
citation: Eisendrath 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.