New ways to cope with depression

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2022
INTERVENTION: Participants are randomised to one of three study arms by specific software. Study arm 1: Intervention Group (bouldering psychotherapy) Participants receive therapy in groups of ten that is led by two psychotherapists/boulder leaders. This programme combines methods of psychotherapy and action‐oriented methods of boulder therapy. It consists of classical approaches such as mindfulness‐based techniques, relaxation methods and cognitive‐behavioural therapy as well as specific boulder exercises. Bouldering is climbing without a rope on climbing walls at an altitude that permits the climber to jump off. Participants are asked to do this for two hours a week for ten weeks and are followed up after 12 months after the end of treatment. Study arm 2: Intervention Group (mental model therapy) Participants receive therapy in groups of ten that is led by two psychotherapists. The intervention is manualized. It is based on cognitive behavioural therapy and focuses on mental models. Participants are asked to do this for two hours a week for ten weeks and are followed up after 12 months after the end of treatment. Study arm 3: control group: There is no additional therapy for the participants of the control group. They get the established psychotherapeutic and psychiatric treatment of the University hospital in Erlangen. CONDITION: Depression ; Mental and Behavioural Disorders PRIMARY OUTCOME: Depression is measured using the score of an observer‐rating scale (Montgomery Asberg Rating Scale, MADRS) by computer‐assisted video interviews at baseline, within two weeks after the intervention and 12 months after the intervention INCLUSION CRITERIA: 1. Depression, diagnosed by a diagnostic interview based on the DSM‐V diagnostic criteria. 2. Informed consent to participate in the study (especially regarding the randomised allocation and data acquisition) 3. Possibility to come to the therapy locations and time capacities to participate in the interventions. SECONDARY OUTCOME: ; 1. Anxiety is measured using the Generalized Anxiety Disorder Scale‐7 (GAD‐7) at baseline, within two weeks after the intervention and 12 months after the intervention.; 2. Self‐efficacy is measured using the ‘Skala zur Allgemeinen Selbstwirksamkeit’ (SWE) at baseline, within two weeks after the intervention and 12 months after the intervention.; 3. The Sense of Coherence is measured using the short version of the ‘Sense of Coherence scale’ (SOC) at baseline, within two weeks after the intervention and 12 months after the intervention.; 4. The Locus of Control is measured using the ‘Internal External Locus of Control’ (IE‐4) at baseline, within two weeks after the intervention and 12 months after the intervention.; 5. The body‐based mindfulness is measured using the ‘State Mindfulness Scale for Physical Activity’ (SMS‐PA‐12) at baseline, within two weeks after the intervention and 12 months after the intervention.; 6. Mindfulness state is measured using the ‘Multidimensional State Mindfulness Questionnaire’ (MSMQ) at baseline, within two weeks after the intervention and 12 months after the intervention.; 7. Physical activity is measured using the ‘BSA‐Questionnaire’ (BSA‐F) at baseline, within two weeks after the intervention and 12 months after the intervention.; 8. Hand strength is measured using the ‘Baseline Hydraulic Hand Dynamometer’ at baseline and within two weeks after the intervention.; 9. Core stability is measured using McGill’s ‘Torso muscular endurance test battery’ at baseline and within two weeks after the intervention.; 10. The blood concentration of osteocalcin is measured using ELISA at baseline and within two weeks after the intervention; 11. Age, gender, height and weight (BMI), occupation, actual treatment (medication/psychotherapy), previous treatment, therapy preferences and experiences with meditation are detected by using open questions at baseline.; 12. Changes concerning actual treatment (medication/psychotherapy) are detected by using open questions within two weeks after the intervention; 13. Cognitive processing is measured by using the ‘cognitive reflection test’ (CRT‐3) within two weeks after the intervention.; 14. To detect effective factors of the group therapies the experience of the therapeutic processes in the groups is measured by using the ‘Fragebogen zum Erleben von therapeutischen Prozessen in der Gruppe’ (FEPiG) and by using semi‐structured interviews about effective factors and the acceptance of the form of therapy within two weeks after the intervention.; 15. The usability of the APP is measured using the ‘mHealth App Usability Questionnaire’ (MAUQ) (Only participants of the bouldering psychotherapy);
Epistemonikos ID: af722376fa6854ab8e8ce6842dd735ccb1dd2aa0
First added on: Aug 25, 2024