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Table 1 Trial Registration Data

From: A German climbing study on depression: a bouldering psychotherapeutic group intervention in outpatients compared with state-of-the-art cognitive behavioural group therapy and physical activation – study protocol for a multicentre randomised controlled trial

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