Table 1 Trial registration data
Data category | Information |
|---|---|
1. Primary registry and trial identification number’ | ISRCTN 12347878 |
2. Date of registration in primary registry | March 28, 2022 |
3. Secondary identifying numbers | - |
4. Source(s) of monetary or material support | University Hospital Erlangen |
5. Primary sponsor | University Hospital Erlangen |
6. Secondary sponsor(s) | - |
7. Contact for public queries | see Point 8 |
8. Contact for scientific queries | PD Dr. Katharina Luttenberger, katharina.luttenberger@uk-erlangen.de |
9. Public title | New ways to cope with depression |
10. Scientific title | New ways to cope with depression—study protocol for a randomized controlled mixed methods trial of bouldering psychotherapy (BPT) and mental model therapy (MMT) |
11. Countries of recruitment | Germany |
12. Health condition(s) or problem(s) studied | Depression |
13. Intervention(s) | Intervention group receiving the bouldering psychotherapy (BPT) |
Intervention group receiving the mental model therapy (MMT) | |
Control group (CG) | |
14. Key inclusion and exclusion criteria | Inclusion criteria: 1. Depressive episode, assessed via virtual diagnostic screening interview based on the DSM-V diagnostic criteria 2. Informed consent to participate in the study (especially regarding the randomized allocation, anonymous storage of data, and data collection) 3. Ability and availability to come to the therapy locations and time to participate as well as access to digital applications for video or telephone interviews |
Exclusion criteria: 1. Age < 18 years 2. Presence of current severe mental illnesses that complicate participation in group therapy (e.g., psychosis, mania, current self-injury, acute substance dependence, current suicidality) 3. Physical contraindication for climbing (physical ailments or pregnancy) 4. Body Mass Index (BMI) < 17.5 or > 40 5. Current treatment confounded with study outcomes (participation in psychotherapeutic group therapy, initiation/change in psychotropic medication within 8 weeks prior to the intervention) | |
15. Study type | Randomized controlled prospective assessor-blinded longitudinal clinical intervention study |
16. Date of first enrollment | Began on March 29, 2022 |
17. Target sample size | 120 |
18. Recruitment status | Ongoing |
19. Primary outcome(s) | Depression measured with the Montgomery Asberg Rating Scale (MADRS) score from a third-party assessment in computer-assisted video interviews |
20. Key secondary outcomes | Anxiety, self-efficacy, sense of coherence, locus of control, (mind- and body-based) state mindfulness, physical activity, mechanisms of therapeutic change in group therapy, blood concentration of osteocalcin, sphingolipid parameters, growth factors and inflammatory markers, qualitative factors of influence |
BPT specific | Hand strength, core stability, BMI, body fat percentage, muscle percentage |
MMT specific | Cognitive processing |