Table 1 Trial Registration Data

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