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| Name | Class |
|---|---|
| Universitätsklinikum Hamburg-Eppendorf | OTHER |
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Randomized trial to proof the effects and efficacy of a new mindfulness and acceptance based group-treatment for depressive patients
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...).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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". |
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| Known Treatment | Sham Comparator | The participants will be treated with a relaxation-treatment, long time established as "jacobson muscle relaxing technique". |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness, Acceptance and Commitment-Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measurement of PHQ-Data 3 months after inclusion of participant |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Tonn, MD | Managing Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuropsychiatric Center of Hamburg | Hamburg | 22769 | Germany |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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One group with new treatment, one group with known and defined treatment
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The participants don't know in which of the both arms they are, the outcome assessor don't know which participant of which study-arm he/she calculate
| Jacobson | Behavioral | Relaxation treatment in technique of Jacobson |
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| 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. | 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. | Measurement of Mindfulness, Acceptance and Commitment 3 months after inclusion of participant |