PsychotherapyMAC_DeprNCT03692130
Treatment of Depression With Mindfulness, Acceptance and Commitment
A study testing Mindfulness, Acceptance and Commitment-Therapy and Jacobson in people with Psychotherapy and Depression, run by Neuropsychiatrischen Zentrums Hamburg-Altona at 1 site in Germany.
Trial summary
Randomized trial to proof the effects and efficacy of a new mindfulness and acceptance based group-treatment for depressive patients Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psychotherapy, Depression
- What is being tested?
- Mindfulness, Acceptance and Commitment-Therapy and Jacobson
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 18 Mar 2019to Mar 2022
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Depressive Disorder
Who cannot join
- Somatic disorder
- psychotic disorder
- personality disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness, Acceptance and Commitment Combined in Cognitive Behavioral Group Therapy (MAC-CBT®) for Patients With Depression
Randomized trial to proof the effects and efficacy of a new mindfulness and acceptance based group-treatment for depressive patients
Read the detailed description
In this study, a randomized trial is conducted in which the participants are allocated to two different care services (MAC-CBT® vs. progressive muscle relaxation). Participants are patients with depression who have been made aware of the group therapy by their treating physicians or psychotherapists or who have read the advertising in waiting areas or on the investigators homepage. An extensive psychometric survey will be conducted at the start of the study in an interview session with a psychotherapist, who also judges if the participants are able to participate in a therapy group. The MAC-CBT® group receives an eight-session group therapy, in which the aspects of mindfulness, acceptance and commitment are taught in detail. The control group will receive an eight-session treatment with progressive muscle relaxation. Input and output results are determined using validated survey instruments. In addition, the investigators will check the data for moderating variables (e.g. age, gender, previous treatments...).
- Conditions
- Psychotherapy, Depression
- Being tested
- Mindfulness, Acceptance and Commitment-Therapy, Jacobson
- Keywords
- Acceptance, Mindfulness, Commitment, Group-Psychotherapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness, Acceptance and Commitment-TherapyBehavioural
Psychotherapeutic intervention to treat depressive patients with special exercises and education to be mindful, to accept situations and behaviors and to commit with the situation or the possibility to change.
JacobsonBehavioural
Relaxation treatment in technique of Jacobson
| Study group | Role | What they receive |
|---|---|---|
| New Treatment | Active comparator | The patients will be treated with psychological group treatment for 8 Sessions with focus on mindfulness, acceptance and commitment in a special adapted treatment process.This will be called "Mindfulness, Acceptance and Commitment-Therapy for depressive Patients". Receives: Behavioral: Mindfulness, Acceptance and Commitment-Therapy |
| Known Treatment | Sham comparator | The participants will be treated with a relaxation-treatment, long time established as "jacobson muscle relaxing technique". Receives: Behavioral: Jacobson |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression - Patient Health Questionnaire-9
Measurement of changes of depressive Symptoms, so called PHQ-9. There will be a measure of the total score, range from 9 to 36, pathological in sense of depression will be any score above 15. There is only one measurement scale (PHQ-9) with nine items, no other measurements or different units in the PHQ-9.
Measured: Measurement of PHQ-Data 3 months after inclusion of participant
Secondary outcomes (3)
Quality of Life - European Quality 5 Dimensions on 3 Levels
Measurements of changes of Quality of life (EQ-5D 3L), there will be a measure of three dimensions of life quality in scores 0-10, the total is a sum and will be added from the single measurements. There is a range from 0-30, no "critical number" is defined, only the sum will be used for interpretation. A higher score represents a better result /state
Measured: Measurement of QoL 3 months after inclusion of participant
Anxiety - Generalized Anxiety Disorder
Measurements of changes of Anxiety (GAD 7), there are 7 questions to check anxiety, the range is from 7-28, pathological in sense of manifest anxiety disorder is a sum above 9 plus the key-question.A lower score represents a better result/ state.
Measured: Measurement of Generalized Anxiety 3 months after inclusion of participant
Acceptance and Commitment - Questionnaire of Mindfulness, Acceptance and Commitment (MAC-Q)
Measurements of changes of Mindfulness, Acceptance and Commitment, that is a measurement with 8 questions, range from 0-32, only the sum will be noticed, no "critics score" is published yet. A higher score represents a better result/ state.
Measured: Measurement of Mindfulness, Acceptance and Commitment 3 months after inclusion of participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start18 Mar 2019
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychotherapyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group with new treatment, one group with known and defined treatment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuropsychiatrischen Zentrums Hamburg-Altona
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Principal investigator, Peter Tonn, Neuropsychiatrischen Zentrums Hamburg-Altona
- Investigators
- Peter Tonn, MD, Principal investigator, Managing Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692130
- Sponsor's protocol ID
- SCHULZE02
- Acronym
- MAC_Depr
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2018
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness, Acceptance and Commitment Combined in Cognitive Behavioral Group Therapy (MAC-CBT®) for Patients With Depression
- ClinicalTrials.gov ID
- NCT03692130
- Acronym / sponsor ID
- MAC_Depr / SCHULZE02
- Conditions
- Psychotherapy, Depression
- Keywords
- Acceptance, Mindfulness, Commitment, Group-Psychotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Neuropsychiatrischen Zentrums Hamburg-AltonaUniversity, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 2 Oct 2018 (actual)
- 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.
Randomized trial to proof the effects and efficacy of a new mindfulness and acceptance based group-treatment for depressive patients
Detailed description
In this study, a randomized trial is conducted in which the participants are allocated to two different care services (MAC-CBT® vs. progressive muscle relaxation). Participants are patients with depression who have been made aware of the group therapy by their treating physicians or psychotherapists or who have read the advertising in waiting areas or on the investigators homepage. An extensive psychometric survey will be conducted at the start of the study in an interview session with a psychotherapist, who also judges if the participants are able to participate in a therapy group. The MAC-CBT® group receives an eight-session group therapy, in which the aspects of mindfulness, acceptance and commitment are taught in detail. The control group will receive an eight-session treatment with progressive muscle relaxation. Input and output results are determined using validated survey instruments. In addition, the investigators will check the data for moderating variables (e.g. age, gender, previous treatments...).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- One group with new treatment, one group with known and defined treatment
| Arm | Type | Receives |
|---|---|---|
| New Treatment | Active comparator | Behavioral: Mindfulness, Acceptance and Commitment-TherapyThe patients will be treated with psychological group treatment for 8 Sessions with focus on mindfulness, acceptance and commitment in a special adapted treatment process.This will be called "Mindfulness, Acceptance and Commitment-Therapy for depressive Patients". |
| Known Treatment | Sham comparator | Behavioral: JacobsonThe participants will be treated with a relaxation-treatment, long time established as "jacobson muscle relaxing technique". |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Depressive Disorder
Key exclusion criteria (3 listed)
- Somatic disorder
- psychotic disorder
- 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, Acceptance and Commitment-TherapyPsychotherapeutic intervention to treat depressive patients with special exercises and education to be mindful, to accept situations and behaviors and to commit with the situation or the possibility to change. | Behavioural | New Treatment |
| JacobsonRelaxation treatment in technique of Jacobson | Behavioural | Known Treatment |
Primary outcome
Depression - Patient Health Questionnaire-9
Time frame: Measurement of PHQ-Data 3 months after inclusion of participant
Measurement of changes of depressive Symptoms, so called PHQ-9. There will be a measure of the total score, range from 9 to 36, pathological in sense of depression will be any score above 15. There is only one measurement scale (PHQ-9) with nine items, no other measurements or different units in the PHQ-9.
3 secondary outcomes
Quality of Life - European Quality 5 Dimensions on 3 Levels
Time frame: Measurement of QoL 3 months after inclusion of participant
Anxiety - Generalized Anxiety Disorder
Time frame: Measurement of Generalized Anxiety 3 months after inclusion of participant
Acceptance and Commitment - Questionnaire of Mindfulness, Acceptance and Commitment (MAC-Q)
Time frame: Measurement of Mindfulness, Acceptance and Commitment 3 months after inclusion of participant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Peter Tonn, MD principal investigator
Managing Director
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, Acceptance and Commitment-Therapy and Jacobson in people with Psychotherapy and Depression, run by Neuropsychiatrischen Zentrums Hamburg-Altona at 1 site in Germany.
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 1 inclusion and 3 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 20 Aug 2021. 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. Some participants in this study may receive a placebo. 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?
Depression - Patient Health Questionnaire-9 (time frame: Measurement of PHQ-Data 3 months after inclusion of participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2021.