Chronic Major DepressionPhase 2NCT01065311

Mindfulness-based Cognitive Therapy for Chronic Depression

A Phase 2 study testing Mindfulness-based Cognitive Therapy, The Cognitive Behavioral Analysis System of Psychotherapy and Standard psychiatric care in people with Chronic Major Depression, run by Johannes Michalak at 1 site in Germany.

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

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Chronic Major Depression
What is being tested?: Mindfulness-based Cognitive Therapy, The Cognitive Behavioral Analysis System of Psychotherapy and Standard psychiatric care
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 106 participants
Where: 1 siteGermany
Study dates: Oct 2010to May 2013
Phase: Phase 2
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnoses of Major Depression, single episode, chronic or
Major Depression, recurrent, chronic
Hamilton Rating Scale for Depression score > 14
Beck Depression Inventory II score > 14

Who cannot join

History of Schizophrenia or Schizoaffective Disorder
Current Substance Dependence or Eating Disorder
Mental Disorder Due to General Medical Condition
Borderline Personality Disorder

Trial locations and contacts

1 site in 1 country.

Germany1 site

University of Hildesheim
Hildesheim, 31141

Other trials in Germany

About this study

The propose of the study is to investigate the efficacy of Mindfulness-based Cognitive Therapy (MBCT, Segal, Williams, \& Teasdale, 2002) for patients suffering from Chronic Major Depression. The efficacy of MBCT will be compared with the Cognitive Behavioral Analysis System of Psychotherapy (McCullough, 2003), a treatment approach, which has proven it's efficacy yet, and with a treatment-as-usual condition (standard psychiatric outpatient care).

Read the detailed description

Cognitive Behavioral Analysis System of Psychotherapy (CBASP) is a treatment approach specifically developed for the treatment of chronic depression. CBASP aims to change dysfunctional interpersonal patterns. Mindfulness-based Cognitive Therapy (MBCT) has recently been proposed as a further treatment option for chronic depression. MBCT trains patients to step out of negative ruminative states of mind. There are no direct comparisons of the psychological treatment options for chronic depression.

Conditions: Chronic Major Depression
Being tested: Mindfulness-based Cognitive Therapy, The Cognitive Behavioral Analysis System of Psychotherapy, Standard psychiatric care
Keywords: Depressive Disorder, Psychotherapy
Medical subject headings: Depressive Disorder

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 is based on an integration of aspects of cognitive behavioral therapy for depression (Beck et al., 1979) with components of the Mindfulness-based Stress Reduction program developed by Kabat-Zinn and colleagues (Kabat-Zinn, 1990). After an initial orientation session, the MBCT program is delivered by an instructor in eight weekly 2.5 hr group sessions
The Cognitive Behavioral Analysis System of PsychotherapyBehavioural
The Cognitive Behavioral Analysis System of Psychotherapy integrates behavioral, cognitive, and interpersonal strategies. After two initial orientation sessions, the MBCT program is delivered weekly by an instructor in eight 2.5 hr group sessions.
Standard psychiatric careBiological
Also called Psychiatric care, neurologic care, ambulant setting
Antidepressant medication and medical care.
Standard psychiatric outpatient care:
All patients were requested to get treated individually either by a psychiatrist or by a licensed psychotherapist (not member of the study team). If patients were already in psychiatric/psychotherapeutic individual treatment at study intake they continued their treatment with this psychiatrist/psychotherapist

Study groups in NCT01065311
Study group	Role	What they receive
Mindfulness-based Cognitive Therapy	Experimental	Mindfulness-based Cognitive Therapy is based on an integration of certain aspects of cognitive behavioral therapy for depression (Beck et al., 1979) and components of the Mindfulness-based Stress Reduction program developed by Kabat-Zinn and colleagues (Kabat-Zinn, 1990). After an initial orientation session, the MBCT program is delivered weekly by an instructor in eight 2.5 hr group sessions. Receives: Behavioral: Mindfulness-based Cognitive Therapy; Biological: Standard psychiatric care
CBASP	Active comparator	The Cognitive Behavioral Analysis System of Psychotherapy integrates behavioral, cognitive, and interpersonal strategies. After two initial orientation sessions, the MBCT program is delivered by an instructor in eight weekly 2.5 hr group sessions. Receives: Behavioral: The Cognitive Behavioral Analysis System of Psychotherapy; Biological: Standard psychiatric care
Treatment-as-usual	Active comparator	Standard psychiatric outpatient care: All patients were requested to get treated individually either by a psychiatrist or by a licensed psychotherapist (not member of the study team). If patients were already in psychiatric/psychotherapeutic individual treatment at study intake they continued their treatment with this psychiatrist/psychotherapist Receives: Biological: Standard psychiatric care

What is being measured

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

Hamilton Rating Scale for Depression
Measured: Change from Baseline in HAM-D at 8 weeks

Secondary outcomes (10)

Beck Depression Inventory II
Measured: Change from Baseline in BDI-II at 8 weeks
Social Adaption Self-evaluation Scale
Measured: Change from Baseline in SASS at 8 weeks
Short Form (36) Health Survey
Measured: Change from Baseline in SF-36 at 8 weeks
Global Assessment of Functioning Scale
Measured: Change from Baseline in HAM-D at 8 weeks
Response Styles Questionnaire
Measured: Change from Baseline in RSQ at 8 weeks
Beck Depression Inventory II
Measured: Change from Baseline in BDI-II at 6 months
Social Adaption Self-evaluation Scale
Measured: Change from Baseline in SASS at 6 months
Short Form (36) Health Survey
Measured: Change from Baseline in SF-36 at 6 months
Global Assessment of Functioning Scale
Measured: Change from Baseline in GAF at 6 months
Response Styles Questionnaire
Measured: Change from Baseline in RSQ at 6 months

Timeline

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

Oct 2010May 2013

First posted9 Feb 2010 (estimated)
Study startOct 2010
Primary completionMar 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chronic Major DepressionStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01065311
Sponsor's protocol ID: DFG Mi 700/4
Status last verified: May 2014
First submitted: 8 Feb 2010
Last updated: 15 May 2014
Results posted: No
Data monitoring committee: No

Publications

Forkmann T, Brakemeier EL, Teismann T, Schramm E, Michalak J. The Effects of Mindfulness-Based Cognitive Therapy and Cognitive Behavioral Analysis System of Psychotherapy added to Treatment as Usual on suicidal ideation in chronic depression: Results of a randomized-clinical trial. J Affect Disord. 2016 Aug;200:51-7. doi: 10.1016/j.jad.2016.01.047. Epub 2016 Apr 19.
PubMed 27128357
Michalak J, Schultze M, Heidenreich T, Schramm E. A randomized controlled trial on the efficacy of mindfulness-based cognitive therapy and a group version of cognitive behavioral analysis system of psychotherapy for chronically depressed patients. J Consult Clin Psychol. 2015 Oct;83(5):951-63. doi: 10.1037/ccp0000042. Epub 2015 Aug 10.
PubMed 26371617

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Psilocybin Therapy for Psychological Distress in Palliative Patients
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All Chronic Major Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mindfulness-based Cognitive Therapy for Chronic Depression
ClinicalTrials.gov ID: NCT01065311
Acronym / sponsor ID: DFG Mi 700/4
Conditions: Chronic Major Depression
Keywords: Depressive Disorder, Psychotherapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: Johannes MichalakUniversity, hospital or other
Study start: Oct 2010
Primary completion: Mar 2013 (actual)
Study completion: May 2013 (actual)
First posted: 9 Feb 2010 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Mindfulness-based Cognitive Therapy	Experimental	Behavioral: Mindfulness-based Cognitive Therapy, Biological: Standard psychiatric careMindfulness-based Cognitive Therapy is based on an integration of certain aspects of cognitive behavioral therapy for depression (Beck et al., 1979) and components of the Mindfulness-based Stress Reduction program developed by Kabat-Zinn and colleagues (Kabat-Zinn, 1990). After an initial orientation session, the MBCT program is delivered weekly by an instructor in eight 2.5 hr group sessions.
CBASP	Active comparator	Behavioral: The Cognitive Behavioral Analysis System of Psychotherapy, Biological: Standard psychiatric careThe Cognitive Behavioral Analysis System of Psychotherapy integrates behavioral, cognitive, and interpersonal strategies. After two initial orientation sessions, the MBCT program is delivered by an instructor in eight weekly 2.5 hr group sessions.
Treatment-as-usual	Active comparator	Biological: Standard psychiatric careStandard psychiatric outpatient care: All patients were requested to get treated individually either by a psychiatrist or by a licensed psychotherapist (not member of the study team). If patients were already in psychiatric/psychotherapeutic individual treatment at study intake they continued their treatment with this psychiatrist/psychotherapist

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Clinical diagnoses of Major Depression, single episode, chronic or
Major Depression, recurrent, chronic
Hamilton Rating Scale for Depression score > 14
Beck Depression Inventory II score > 14

Key exclusion criteria (4 listed)

History of Schizophrenia or Schizoaffective Disorder
Current Substance Dependence or Eating Disorder
Mental Disorder Due to General Medical Condition
Borderline Personality Disorder

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 TherapyMindfulness-based Cognitive Therapy is based on an integration of aspects of cognitive behavioral therapy for depression (Beck et al., 1979) with components of the Mindfulness-based Stress Reduction program developed by Kabat-Zinn and colleagues (Kabat-Zinn, 1990). After an initial orientation session, the MBCT program is delivered by an instructor in eight weekly 2.5 hr group sessions	Behavioural	Mindfulness-based Cognitive Therapy
The Cognitive Behavioral Analysis System of PsychotherapyThe Cognitive Behavioral Analysis System of Psychotherapy integrates behavioral, cognitive, and interpersonal strategies. After two initial orientation sessions, the MBCT program is delivered weekly by an instructor in eight 2.5 hr group sessions.	Behavioural	CBASP
Standard psychiatric careAlso: Psychiatric care, neurologic care, ambulant settingAntidepressant medication and medical care. Standard psychiatric outpatient care: All patients were requested to get treated individually either by a psychiatrist or by a licensed psychotherapist (not member of the study team). If patients were already in psychiatric/psychotherapeutic individual treatment at study intake they continued their treatment with this psychiatrist/psychotherapist	Biological	CBASP, Mindfulness-based Cognitive Therapy, Treatment-as-usual

Primary outcome

Hamilton Rating Scale for Depression
Time frame: Change from Baseline in HAM-D at 8 weeks

10 secondary outcomes

Beck Depression Inventory II
Time frame: Change from Baseline in BDI-II at 8 weeks
Social Adaption Self-evaluation Scale
Time frame: Change from Baseline in SASS at 8 weeks
Short Form (36) Health Survey
Time frame: Change from Baseline in SF-36 at 8 weeks
Global Assessment of Functioning Scale
Time frame: Change from Baseline in HAM-D at 8 weeks
Response Styles Questionnaire
Time frame: Change from Baseline in RSQ at 8 weeks
Beck Depression Inventory II
Time frame: Change from Baseline in BDI-II at 6 months
Social Adaption Self-evaluation Scale
Time frame: Change from Baseline in SASS at 6 months
Short Form (36) Health Survey
Time frame: Change from Baseline in SF-36 at 6 months
Global Assessment of Functioning Scale
Time frame: Change from Baseline in GAF at 6 months
Response Styles Questionnaire
Time frame: Change from Baseline in RSQ at 6 months

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2014.
Derived from this study: PubMed 27128357Forkmann T, Brakemeier EL, Teismann T, Schramm E, Michalak J. The Effects of Mindfulness-Based Cognitive Therapy and Cognitive Behavioral Analysis System of Psychotherapy added to Treatment as Usual on suicidal ideation in chronic depression: Results of a randomized-clinical trial. J Affect Disord. 2016 Aug;200:51-7. doi: 10.1016/j.jad.2016.01.047. Epub 2016 Apr 19.
Derived from this study: PubMed 26371617Michalak J, Schultze M, Heidenreich T, Schramm E. A randomized controlled trial on the efficacy of mindfulness-based cognitive therapy and a group version of cognitive behavioral analysis system of psychotherapy for chronically depressed patients. J Consult Clin Psychol. 2015 Oct;83(5):951-63. doi: 10.1037/ccp0000042. Epub 2015 Aug 10.

Related trials for Chronic Major Depression

RecruitingPhase 1
Remote Medical Monitoring of Patients With Depression
Depression Chronic, Depression and Quality of Life
Not yet recruiting
An Interrupted Time-Series Pilot Trial of LGBTQ-Affirming Cognitive Processing Therapy for Interpersonal and Developmental Trauma
Post-Traumatic Stress Disorder, Chronic, Depressed Mood
Recruiting
Comparing the Efficacy of Heated Yoga and Sauna as a Treatment for Depression
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RecruitingPhase 2
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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.

Johannes Michalak, PD Dr. phil. principal investigator

University of Hildesheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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: finished, as of the sponsor's last update on 15 May 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 Germany. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Rating Scale for Depression (time frame: Change from Baseline in HAM-D at 8 weeks). 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 NCT01065311, which also lists 2 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 15 May 2014; AzTrials last refreshed its copy on 30 Oct 2026.