Table 1.
Data category | Information |
---|---|
1. Primary registry and trial identification number | ISRCTN12457760 |
2. Date of registration in primary registry | 26 July 2017 |
3. Secondary identifying numbers | – |
4. Source(s) of monetary or material support |
OH-DO-KWAN Stiftung Ludmilla Pankofer und Carl Wiedmeier Förderverein Kletterzentrum Aufwärts in Miesbach e.V. |
5. Primary sponsor | OH-DO-KWAN Stiftung Ludmilla Pankofer und Carl Wiedmeier |
6. Secondary sponsor(s) | Förderverein Kletterzentrum Aufwärts in Miesbach e.V. |
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 | Study KuS (Klettern und Stimmung - Climbing and Mood), a combination of bouldering and psychotherapy for treating depression |
10. Scientific title | Study KuS (Klettern und Stimmung - Climbing and Mood) - Prospective investigation of the effectiveness of a combination of bouldering and psychotherapy in comparison with an active control group and cognitive behavioural group therapy for patients suffering from depression in an outpatient setting |
11. Countries of recruitment | Germany |
12. Health condition(s) or problem(s) studied | Depression |
13. Intervention(s) | Study arm 1: Intervention group receiving the combination of bouldering and psychotherapy |
Study arm 2: Intervention group receiving cognitive-behavioural therapy | |
Study arm 3: Active control group | |
1.14. Key inclusion and exclusion criteria |
Ages eligible for study: adults; Sexes eligible for study: both |
Inclusion criteria: 1. Depression, measured by the patient’s score on the PHQ-9 (Cut-off ≥8) 2. Informed consent to participate in the study (especially regarding randomised allocation and data acquisition) 3. Ability to come to the therapy locations | |
Exclusion criteria: 1. Acute suicidality 2. Severe psychiatric disorder (psychosis, mania, substance abuse) 3. Physical contraindication for climbing due to disorder or pregnancy 4. BMI < 17.5 or > 40 5. Age < 18 years 6. Actual participation in group psychotherapy 8. Began using psychiatric medication within the last 8 weeks 9. Began psychotherapy within the last 8 weeks 10. Planned inpatient stay during therapy | |
15. Study type | Randomised controlled intervention study |
16. Date of first enrollment | June 2017 |
17. Target sample size | 199 |
18. Recruitment status | complete |
19. Primary outcome(s) | Depression measured using the score on an observer rating scale (Montgomery Asberg Rating Scale, MADRS) by computer-assisted telephone interviews (CATI) |
20. Key secondary outcomes | e.g., body image, anxiety, social phobia, self-esteem, coping |