Condition category
Mental and Behavioural Disorders
Date applied
15/07/2015
Date assigned
24/07/2015
Last edited
22/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Katharina Luttenberger

ORCID ID

Contact details

Psychiatrische Universitätsklinik Erlangen
Schwabachanlage 6
Erlangen
91054
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Indoor 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)

Acronym

KuS

Study hypothesis

Bouldering 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

Ethics committee of the medical faculty, Friedrich-Alexander University Erlangen-Nuremberg, 15/05/2013,
ref: 99_13 B

Study design

Randomised waitlist-controlled pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Depression

Intervention

The 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 type

Behavioural

Phase

Drug names

Primary outcome measures

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).

Secondary outcome measures

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).

Overall trial start date

01/04/2013

Overall trial end date

30/09/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80; intervention group: 40; waitlist group: 40

Participant exclusion criteria

1. 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

Recruitment start date

01/06/2013

Recruitment end date

31/10/2014

Locations

Countries of recruitment

Germany

Trial participating centre

University Hospital Erlangen (Universitätsklinikum Erlangen)
Erlangen
91054
Germany

Sponsor information

Organisation

Psychiatric University Hospital Erlangen (Germany)

Sponsor details

c/o Prof. J. Kornhuber
Schwabachanlage 6
Erlangen
91054
Germany

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

University Hospital Erlangen, Department of Psychiatry and Psychotherapy (Psychiatrische und Psychotherapeutische Uniklinik Erlangen)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We already submitted the study design and very first results to BMC Psychiatry, additionally we plan of course to publish the results and the follow up data – if possible also in BMC journals.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26302900

Publication citations

Additional files

Editorial Notes

22/02/2016: added publication reference.