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History of Changes for Study: NCT01473615
Mindfulness Based Cognitive Therapy for the Treatment of Unipolar Depression in Patients With Neuropathic Pain
Latest version (submitted May 6, 2013) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 14, 2011 None (earliest Version on record)
2 November 22, 2011 Eligibility and Study Status
3 December 1, 2011 Recruitment Status, Study Status and Contacts/Locations
4 January 19, 2012 Study Identification, Eligibility, Study Description and Study Status
5 April 20, 2012 Study Status, Conditions and Study Description
6 July 12, 2012 Contacts/Locations and Study Status
7 May 6, 2013 Recruitment Status, Study Status and Contacts/Locations
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Study NCT01473615
Submitted Date:  November 14, 2011 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2011P001699
Brief Title: Mindfulness Based Cognitive Therapy for the Treatment of Unipolar Depression in Patients With Neuropathic Pain
Official Title: Mindfulness Based Cognitive Therapy for the Treatment of Unipolar Depression in Patients With Neuropathic Pain
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2011
Overall Status: Not yet recruiting
Study Start: November 2011
Primary Completion: January 2013 [Anticipated]
Study Completion: January 2013 [Anticipated]
First Submitted: November 9, 2011
First Submitted that
Met QC Criteria:
November 14, 2011
First Posted: November 17, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 14, 2011
Last Update Posted: November 17, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Massachusetts General Hospital
Responsible Party: Principal Investigator
Investigator: Heidi Ashih
Official Title: Principal Investigator, Clinical Instructor
Affiliation: Massachusetts General Hospital
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief 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 neuropathic 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 fMRI scans of the brain and blood measures before and after the intervention.

Main hypotheses:

  1. The MBCT training will be a feasible intervention in patients with neuropathic 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.
  2. 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.
Detailed Description:
Open or close this module Conditions
Conditions: Major Depressive Disorder
Dysthymic Disorder
Depressive Disorder NOS
Neuropathic Pain
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Outcomes Assessor)
Allocation: Randomized
Enrollment: 60 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Treatment As Usual + Mindfulness Based Cognitive Therapy
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).
Behavioral: Mindfulness Based Cognitive Therapy
A manualized 8-week MBCT group skills program with weekly sessions that each last 2 hours. The MBCT sessions combine elements of cognitive therapy with a mindful approach to thoughts and feelings, including a significant meditation component. The program is specifically tailored to a population that suffers from active depressive symptoms and chronic pain. The program also includes daily homework exercises.
No Intervention: Treatment As Usual
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
[ Time Frame: week 8 ]

Secondary Outcome Measures:
1. Response according to the Beck Anxiety Inventory, 21 items (BAI).
[ Time Frame: Baseline, week 8, 6 months, 12 months ]

2. Response according to Short Form Health Survey, 36 items (SF-36).
[ Time Frame: Baseline, week 8, 6 months, 12 months ]

3. Response according to Brief Pain Inventory (BPI-sf).
[ Time Frame: Baseline, week 4, week 8, 6 months, 12 months ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Referred to Center for Pain Medicine, MGH (CPM) for evaluation/treatment of chronic pain.
  • Meets criteria for NP, per a score of ≥ 12 on the S-LANSS (administered by phone) and has the clinical diagnosis of NP as the primary diagnosis as checked in LMR.
  • Meets criteria of Major Depressive Disorder, Dysthymic Disorder or Depressive disorder NOS as defined by DSM-IV criteria.
  • Have a minimum score of depressive symptoms of > 11 as rated on the QIDS-C, administered during the screen.
  • Able to provide written informed consent.
  • Adults 18 years or older
  • English-language literacy.

Exclusion Criteria:

  • Serious suicide or homicide risk, as assessed by evaluating clinician.
  • Severe and unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological or hematological disease for which hospitalization is likely to be required within the next half year.
  • The following DSM-IV disorders: any bipolar disorder (current or past), current psychotic symptoms, or a primary psychotic disorder (current or past). Entry of patients with anxiety disorder will be permitted if the depressive disorder is judged to be the predominant disorder, in order to increase accrual of a clinically relevant sample.
  • Active diagnosis of substance use or dependence disorders within the last 3 months.
  • General conditions that would impede participation in a group intervention, as assessed by evaluating clinician (severe characterological disorders, cognitive impairment, tendencies toward physical aggression).
  • Past or current Mindfulness Based Cognitive Therapy (MBCT), Mindfulness Based Stress Reduction (MBSR) or Relaxation Response(RR)training.
  • Significant meditation training and practice in the past. Specifically no more than 4 classes in meditation in the past year and no more than 1 class per week of Vipassana yoga or Tai Chi in the past year.
  • Psychotherapy and other psychosocial treatment are allowed, and changes in this treatment are allowed, though subjects are asked to make as less changes as possible in their psychosocial treatment for the duration of the study and 8 weeks prior to the study. Psychiatric medication use and changes in psychiatric medications are allowed, though subjects are asked to stay on a stable dose for the duration of the study and 8 weeks prior to the study as much as possible.
  • Women who are pregnant, have plans to conceive, or are unwilling to comply with birth control requirements.
  • Subjects who have litigation pending of any sort in relation to their pain condition.
  • Metallic implants
  • Extreme claustrophobia-like discomfort with the scanning procedure
  • Left handedness
  • Epilepsy
Open or close this module Contacts/Locations
Central Contact Person: Aya Inamori, BA
Telephone: 617-724-0586
Email: ainamori@partners.org
Study Officials: Heidi Ashih, MD, PhD
Principal Investigator
Massachusetts General Hospital
Marasha De Jong, MD
Principal Investigator
Masachusetts General Hospital
Locations: United States, Massachusetts
MGH Depression Clinical and Research Program
Boston, Massachusetts, United States, 02114
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: Teasdale JD, Segal ZV, Williams JM, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psychol. 2000 Aug;68(4):615-23. PubMed 10965637
Veehof MM, Oskam MJ, Schreurs KMG, Bohlmeijer ET. Acceptance-based interventions for the treatment of chronic pain: a systematic review and meta-analysis. Pain. 2011 Mar;152(3):533-542. doi: 10.1016/j.pain.2010.11.002. Epub 2011 Jan 19. Review. PubMed 21251756
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