Depression, Psychotherapy
Conditions
Keywords
Acceptance, Mindfulness, Commitment, Group-Psychotherapy
Brief summary
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...).
Interventions
BEHAVIORALMindfulness, Acceptance and Commitment-Therapy
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.
BEHAVIORALJacobson
Relaxation treatment in technique of Jacobson
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Neuropsychiatrischen Zentrums Hamburg-Altona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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
Intervention model description
One group with new treatment, one group with known and defined treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Depressive Disorder
Exclusion criteria
* Somatic disorder * psychotic disorder * personality disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression - Patient Health Questionnaire-9 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life - European Quality 5 Dimensions on 3 Levels | Measurement of QoL 3 months after inclusion of participant | 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 |
| Anxiety - Generalized Anxiety Disorder | Measurement of Generalized Anxiety 3 months after inclusion of participant | 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. |
| Acceptance and Commitment - Questionnaire of Mindfulness, Acceptance and Commitment (MAC-Q) | Measurement of Mindfulness, Acceptance and Commitment 3 months after inclusion of participant | 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. |
Countries
Germany
Outcome results
None listed