ISRCTN ISRCTN17623318
DOI https://doi.org/10.1186/ISRCTN17623318
Protocol serial number N/A
Sponsor Psychiatric University Hospital Erlangen (Germany)
Funder Universitätsklinikum Erlangen
Submission date
15/07/2015
Registration date
24/07/2015
Last edited
18/08/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
We are carrying out a study to investigate the effects of a bouldering treatment on patients with depression. Bouldering is defined as rock climbing to moderate heights (up to around four metres) without rope. The study aims to develop a manual for an eight-week treatment that integrates psychotherapeutic interventions in a bouldering group setting and to assess the effects of a bouldering treatment on people with depression.

Who can participate?
Adults with depression. The study is not restricted to a certain age range.

What does the study involve?
All participants receive the bouldering treatment. The treatment takes place for three hours once a week over a period of eight weeks. Patients are randomly assigned to two groups (intervention vs. waiting list). At first, the intervention group receives the treatment and after eight weeks of treatment the groups change and the waiting list group also receives the treatment. Every 8 weeks for 24 weeks, the patients complete several questionnaires concerning their psychological well-being.

What are the possible benefits and risks of participating?
Those participating in the study receive a free eight week physical activity programme estimated to have beneficial effects on physical and psychological well-being. In the long run we hope to find an effective supplementary treatment for depression. Another advantage is the implementation of the treatment in a group setting which is more cost-efficient in comparison to individual treatment. Additionally, we expect to gain evidence-based understanding on treatment programmes. The highest risk for participants would be a sport injury which is expected to be very unlikely. A current study on the incidence of climbing-associated injuries found that the average was 0.2 injuries per 1,000 h of outdoor rock climbing. In a supervised indoor bouldering setting, this should be even less, but of course all participants must adhere to the safety rules given by the therapists, and therapists must be trained in climbing safety.

Where is the study run from?
University Hospital Erlangen (Germany)

When is the study starting and how long is it expected to run for?
April 2013 to September 2015

Who is funding the study?
University Hospital Erlangen (Germany)

Who is the main contact?
Dr Katharina Luttenberger
katharina.luttenberger@uk-erlangen.de

Contact information

Dr Katharina Luttenberger
Scientific

Psychiatrische Universitätsklinik Erlangen
Schwabachanlage 6
Erlangen
91054
Germany

Study information

Primary study designInterventional
Study designRandomized waitlist-controlled pilot study
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleIndoor rock climbing (bouldering) as a new treatment for depression: Study design of a waitlist-controlled randomized group pilot study (Klettern Und Stimmung: Bouldern als neuer Behandlungsbaustein für Menschen mit Depression)
Study acronymKuS
Study objectivesBouldering might be a valuable additional therapy for people with depression. In this pilot study we intend to develop a manual for an eight-week interventional program that integrates psychotherapeutic interventions in a bouldering group setting. We hypothesize that patients undergoing the bouldering treatment might reduce their depression scores to a greater extent than patients in the waitlist group, undergoing their individual treatment (TAU). Additionally a number of other depression related symptoms will be evaluated in explorative analyses.
Ethics approval(s)Ethics committee of the medical faculty, Friedrich-Alexander University Erlangen-Nuremberg, 15/05/2013,
ref: 99_13 B
Health condition(s) or problem(s) studiedDepression
InterventionThe study is conducted as a randomised waitlist-controlled pilot study with an intervention period of 8 weeks. Both groups (intervention and waitlist) take part in the intervention program but with a delay for the waitlist group of 2 months. During the whole time both groups are free to take part in their individual treatment (e.g. medication, psychotherapy), prescribed by their physicians. These treatments that are not influenced by the study. The bouldering treatment consists of a 8-week manual on depression related problems and is held once a week for 3h each session. Each session starts and ends with a short mindfulness-based meditation and has a specific topic such as "fear and coping with it", "own limitations", "how to achieve personal goals" etc. These topics are worked with in specific bouldering-plays as for example climbing blindfolded, feeling support from others etc. The therapy is held in groups of about 12 patients with two therapists.
Intervention typeBehavioural
Primary outcome measure(s)

The BDI-II is used to measure the intensity of depression. Measured at baseline (t0), after 8 weeks (t1), 16 weeks (t2), and 24 weeks (t3).

Key secondary outcome measure(s)

1. SCL-90-R (global intensity of psychological symptoms and distress)
2. FERUS (individuals' health-related resources and manageability)
3. d2-R (attention and concentration performance)
Measured at baseline (t0), after 8 weeks (t1), 16 weeks (t2), and 24 weeks (t3).

Completion date30/09/2015

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration80
Key inclusion criteria1. Diagnosis of depression by a psychiatrist or less than 13 points on the WHO depression scale,
2. Informed consent
3. Having free time on Thursday mornings during the intervention period
4. BMI between 18.5 and 35
Key exclusion criteria1. Undergoing in-patient treatment during either the intervention or the waiting periods
2. Acute suicidality or psychosis
3. Medical contraindication against sport, determined by a GP or psychiatrist
Date of first enrolment01/06/2013
Date of final enrolment31/10/2014

Locations

Countries of recruitment

  • Germany

Study participating centre

University Hospital Erlangen (Universitätsklinikum Erlangen)
Erlangen
91054
Germany

Results and Publications

Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 25/08/2015 Yes No
Results article 07/12/2019 18/08/2023 Yes No
Results article 23/03/2018 18/08/2023 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

18/08/2023: Publication references added.
22/02/2016: added publication reference.