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Major Depressive DisorderPATH-DNCT00871299

Practicing Alternative Techniques to Heal From Depression: The PATH-D Study

A study testing Mindfulness Based Cognitive Therapy and Health Enhancement Program and medication management in people with Major Depressive Disorder, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Major Depressive Disorder
What is being tested?
Mindfulness Based Cognitive Therapy and Health Enhancement Program and medication management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
173 participants
Where
1 siteUnited States
Study dates
Sep 2009to Jun 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California, San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: Applying Mindfulness-Based Cognitive Therapy to Treatment Resistant Depression

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.

Being tested
Mindfulness Based Cognitive Therapy, Health Enhancement Program and medication management
Keywords
Treatment-resistant depression, meditation, mindfulness
Medical subject headings
Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness Based Cognitive TherapyBehavioural

    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.

  • Health Enhancement Program and medication managementBehavioural

    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.

Study groups in NCT00871299
Study groupRoleWhat they receive
1ExperimentalMindfulness Based Cognitive Therapy (MBCT) + medication management
Receives: Behavioral: Mindfulness Based Cognitive Therapy
2Active comparatorThe Health Enhancement Program (HEP) + medication management
Receives: Behavioral: Health Enhancement Program and medication management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hamilton Depression Rating Scale (HAMD-17)

    Measured: Baseline, 4, 8, 24, 36, 52 week

Secondary outcomes (5)

  1. Quick Inventory of Depressive Symptomatology(Self-Rated)-16 items(QIDS-SR16)

    Measured: Baseline, weeks 1-8, 24, 36, 52 week

  2. Short Form Health Survey-36

    Measured: Baseline, 8, 24, 36, 52 week

  3. Clinical Global Improvement Scale (CGI)

    Measured: Baseline, 8, 24, 36, 52 weeks

  4. Work and Social Activity Scale (WSAS)

    Measured: Baseline, 8, 24,36,52 weeks

  5. Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (QLESQ-SF)

    Measured: Baseline, 8, 24, 36, 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
173 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00871299
Sponsor's protocol ID
R01 AT004572-O1A1
Other IDs
R01AT004572-01A1, 3063975
Acronym
PATH-D
Status last verified
Dec 2014
First submitted
27 Mar 2009
Last updated
2 Dec 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 14399272

  • 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.

    PubMed 12562566

  • 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.

    PubMed 16554525

  • 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.

    PubMed 8628042

  • 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.

    PubMed 11983645

  • 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.

    PubMed 8290681

  • 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.

    PubMed 24612825

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Based Cognitive Therapy and Health Enhancement Program and medication management in people with Major Depressive Disorder, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hamilton Depression Rating Scale (HAMD-17) (time frame: Baseline, 4, 8, 24, 36, 52 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00871299, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.

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