NCT01473615

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 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:

  1. 1.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.
  2. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 17, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 7, 2013

Status Verified

May 1, 2013

Enrollment Period

1.6 years

First QC Date

November 9, 2011

Last Update Submit

May 6, 2013

Conditions

Major Depressive DisorderDysthymic DisorderDepressive Disorder NOSChronic Pain

Outcome Measures

Primary Outcomes (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.

    week 8

Secondary Outcomes (3)

  • Response according to the Beck Anxiety Inventory, 21 items (BAI).

    Baseline, week 8, 6 months, 12 months

  • Response according to Short Form Health Survey, 36 items (SF-36).

    Baseline, week 8, 6 months, 12 months

  • Response according to Brief Pain Inventory (BPI-sf).

    Baseline, week 4, week 8, 6 months, 12 months

Study Arms (2)

Treatment As Usual + Mindfulness Based Cognitive Therapy

EXPERIMENTAL

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

Treatment As Usual

NO 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.

Interventions

Mindfulness Based Cognitive TherapyBEHAVIORAL

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.

Treatment As Usual + Mindfulness Based Cognitive Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The presence of Chronic Pain, which has persisted for at least 3 months.
  • 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 \> 10 as rated on the QIDS-C, administered during the screen.
  • Able to provide written informed consent.
  • Adults 18 years or older
  • English-language literacy.

You may not qualify if:

  • 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 abuse or dependence disorders within the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MGH Depression Clinical and Research Program

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

  • 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. doi: 10.1037//0022-006x.68.4.615.

    PMID: 10965637BACKGROUND

  • 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.

    PMID: 21251756BACKGROUND

  • de Jong M, Peeters F, Gard T, Ashih H, Doorley J, Walker R, Rhoades L, Kulich RJ, Kueppenbender KD, Alpert JE, Hoge EA, Britton WB, Lazar SW, Fava M, Mischoulon D. A Randomized Controlled Pilot Study on Mindfulness-Based Cognitive Therapy for Unipolar Depression in Patients With Chronic Pain. J Clin Psychiatry. 2018 Jan/Feb;79(1):15m10160. doi: 10.4088/JCP.15m10160.

    PMID: 28252881DERIVED

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorDysthymic DisorderDepressionChronic Pain

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehaviorPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Heidi Ashih, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Marasha De Jong, MD

    Masachusetts General Hospital

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Instructor

Study Record Dates

First Submitted

November 9, 2011

First Posted

November 17, 2011

Study Start

November 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2014

Last Updated

May 7, 2013

Record last verified: 2013-05

Locations

US(1)