Major Depressive DisorderNCT01473615
Mindfulness Based Cognitive Therapy for Chronic Pain and Comorbid Unipolar Depression
A study testing Mindfulness Based Cognitive Therapy in people with Major Depressive Disorder and Dysthymic Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder, Dysthymic Disorder, Depressive Disorder NOS
- What is being tested?
- Mindfulness Based Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH Depression Clinical and Research Program
Boston, Massachusetts, 02114
About this study
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:
- 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.
- 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.
- Being tested
- Mindfulness Based Cognitive Therapy
- Medical subject headings
- Depressive Disorder, Major, Dysthymic Disorder, Depression, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Cognitive TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 8
Secondary outcomes (3)
Response according to the Beck Anxiety Inventory, 21 items (BAI).
Measured: Baseline, week 8, 6 months, 12 months
Response according to Short Form Health Survey, 36 items (SF-36).
Measured: Baseline, week 8, 6 months, 12 months
Response according to Brief Pain Inventory (BPI-sf).
Measured: Baseline, week 4, week 8, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2013 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi Ashih, Massachusetts General Hospital
- Investigators
- Heidi Ashih, MD, PhD, Principal investigator, Massachusetts General HospitalMarasha De Jong, MD, Principal investigator, Masachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473615
- Sponsor's protocol ID
- 2011P001699
- Status last verified
- May 2013
- First submitted
- 9 Nov 2011
- Last updated
- 7 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10965637Veehof 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.
PubMed 21251756de 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.
PubMed 28252881
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Based Cognitive Therapy for Chronic Pain and Comorbid Unipolar Depression
- ClinicalTrials.gov ID
- NCT01473615
- Acronym / sponsor ID
- 2011P001699
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual + Mindfulness Based Cognitive Therapy | Experimental | Behavioral: Mindfulness Based Cognitive TherapySubjects 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). |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Cognitive TherapyA 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. | Behavioural | Treatment As Usual + Mindfulness Based Cognitive Therapy |
Primary outcome
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
3 secondary outcomes
Response according to the Beck Anxiety Inventory, 21 items (BAI).
Time frame: Baseline, week 8, 6 months, 12 months
Response according to Short Form Health Survey, 36 items (SF-36).
Time frame: Baseline, week 8, 6 months, 12 months
Response according to Brief Pain Inventory (BPI-sf).
Time frame: Baseline, week 4, week 8, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2013.
- Background: PubMed 10965637Teasdale 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.
- Background: PubMed 21251756Veehof 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.
- Derived from this study: PubMed 28252881de 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.
- Depression Clinical and Research ProgramLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi Ashih, MD, PhD principal investigator
Massachusetts General Hospital
Marasha De Jong, MD principal investigator
Masachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Cognitive Therapy in people with Major Depressive Disorder and Dysthymic Disorder, run by Massachusetts General Hospital 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 May 2013. 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?
Results are not available in the source record.
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?
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). 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 NCT01473615, which also lists 3 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 7 May 2013.