Condition category
Mental and Behavioural Disorders
Date applied
12/06/2017
Date assigned
26/07/2017
Last edited
26/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
People with depression often feel down or sad for a weeks or months, requiring treatment and support. Depression is usually treated with a combination of medication and therapy. With the relationship between mood and exercise, researchers are exploring alternative treatments. A new therapy method called “Klettern und Stimmung- Climbing and mood (KUS)” uses action-oriented elements from the field of climbing to increase the mood of patients suffering from depression. Former studies have shown that bouldertherapy, a therapy approach that combines psychotherapeutic interventions (therapy that treats mental disorders using methods like talking, mindfulness and relaxation) in a bouldering group setting, has proven effective in the treatment of depression. However it is unsure if it is just as effective as more established methods. The aim of this study is to find out if this combination of bouldertherapy can be as effective as the well-established methods of therapy by comparing the outcomes of participants with depression.

Who can participate?
Adults aged 18 and older who have depression.

What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group receive a combination of bouldering and therapy. Bouldering consists of climbing without ropes and the therapy consists of relaxation methods, mindfulness and cognitive based therapy (talking therapy). Those in the second group receive the cognitive behavioural therapy. Those in the last group receive instructions for an exercise programme that addresses the same muscles used in bouldering. They are reminded to exercise with letters and emails and have an option to participate in the bouldering group after they finish their programme. All participants are asked to complete their programmes for two hours a week for ten weeks. Participants are followed up three, six and 12 months after the treatment to measure their depression, anxiety, self-esteem and body image.

What are the possible benefits and risks of participating?
Participants may benefit from the therapy, as it has been proven effective in treating depression in former studies. There is a risk of slight injuries in the boulder groups; however this does not exceed the risk of other physical activities.

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

When is the study starting and how long is it expected to run for?
October 2016 to October 2019

Who is funding the study?
Oh-Do-Kwan foundation (Germany)

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

Trial website

www.studieKuS.de

Contact information

Type

Scientific

Primary contact

Dr Katharina Luttenberger

ORCID ID

http://orcid.org/0000-0002-9877-5423

Contact details

Universitätsklinikum Erlangen
Psychiatrische und Psychotherapeutische Klinik
Bereich Medizinische Psychologie und Medizinische Soziologie
Schwabachanlage 6
Erlangen
91054
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

360_16B

Study information

Scientific title

Study KuS (Klettern und Stimmung - Climbing and Mood)- Prospective investigation of the effectiveness of a combined boulder- and psychotherapy in comparison of an active control group and a cognitive behavioral group therapy for patients suffering of depression in an outpatient setting

Acronym

Studie KuS

Study hypothesis

1. Patients participating at the combined boulder- and psychotherapy improve (regarding the severity of their Depression measured by the MADRS) significantly more than patients participating at the active control group
2. Patients participating at the combined boulder- and psychotherapy improve (regarding the severity of their Depression measured by the MADRS) about as much as patients participating at cognitive-behavioral psychotherapy

Ethics approval

Friedrich-Alexander-Universität Erlangen-Nürnberg, 02.02.2017, ref: 360_16B

Study design

Interventional three armed multicenter blinded randomised study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

See additional files (in German)

Condition

Depression

Intervention

Participants are randomised to the one of three study arms by specific software.

Study arm 1: Intervention Group (Combined boulder and psychotherpay)
Participants receive therapy in groups of ten that is lead by two psychotherapists/boulder leaders. This programme combines methods of psychotherapy and action-oriented methods of boulder therapy. It consists of classical approaches such as mindfulness-based techniques, relaxation methods and cognitive-behavioral therapy as well as specific boulder exercises. Bouldering is climbing without rope on climbing walls at an altitude which permits the climber to jump off. Participants are asked to do this for two hours a week for ten weeks and are followed up for 12 months (at three, six and 12 months after the end of treatment).

Study arm 2: Intervention Group cognitive-behavioral therapy:
Participants receive therapy in groups of ten that is lead by two psychotherapists. The intervention is manualized and follows the treatment plan of a classical cognitive-behavioral therapy and integrates mindfulness-based techniques and relaxation methods. Participants are asked to do this for two hours a week for ten weeks and followed up for 12 months (at three, six and 12 months after the end of treatment.

Study arm 3: Active control Group:
This consists of a physical training programme which addresses the same muscles as bouldering or climbing. The participants receive instructions for the programme per training manual and DVD as well as information about the link between exercising and mood. They are regularly reminded to exercise with letters and emails. Participants are asked to do this for two hours a week for ten weeks and followed up for 12 months (at three, six and 12 months after the end of treatment. After ten weeks, participants are offered to participating in the boulder group.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Depression is measured using the score of an observer-rating-scale (Montgomery Asberg Rating Scale, MADRS) by computer-assisted telephone interviews (CATI) at baseline, ten weeks, three, six and 12 months

Secondary outcome measures

1. Attitude towards the own body/body image is measured using scale "Vitale Körperdynamik" of the Fragebogen zum Körperbild (FKB-20) at baseline, ten weeks, three, six and 12 months
2. Anxiety is measured using Generalizied Anxiety Disorder Scale-7 (GAD-7) at baseline, ten weeks, three, six and 12 months
3. Social Phobia is measured using scale interpersonal sesitivity of the Symptom-Checklist (SCL-90-R) at baseline, ten weeks, three, six and 12 months
4. Avoidance Behavior is measured using the Items of the scale Mobility Inventory (MI) of the "Fragebogen zu körperbezogenen Ängsten, Kognitionen und Vermeidung (AKV)" at baseline, ten weeks, three, six and 12 months
5. Self-esteem is measured using the Rosenberg self-esteem scale (RSE) at baseline, ten weeks, three, six and 12 months
6. Self-efficacy is measured using the Skala zur Allgemeinen Selbstwirksamkeit (SWE) at baseline, ten weeks, three, six and 12 months
7. Coping is measured using the Coping-scale of the "Fragebogen zur Erfassung von Ressourcen und Selbstmanagementfähigkeiten (FERUS) at baseline, ten weeks, three, six and 12 months

Overall trial start date

01/10/2016

Overall trial end date

01/10/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Depression, measured by the score of the PHQ-9 (Cut-off ≥ 10)
2. Informed Consent to participate in the study (especially regarding randomised allocation and data aquisition)
3. Possibility to come to the therapy locations

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

183, with 61 patients per study arm at t1

Participant exclusion criteria

1. Acute suicidality
2. Severe psychiatric disorder (psychosis, mania, substance-abuse)
3. Physical contraindication (physical disorders or pregnancy)
4. BMI <18,5 or >35
5. Age < 18 years
6. Actual participation in group psychotherapy
8. Start of psychiatric medication within the last 8 weeks
9. Planned in-Patient stay during therapy

Recruitment start date

27/03/2017

Recruitment end date

01/04/2018

Locations

Countries of recruitment

Germany

Trial participating centre

University Hospital Erlangen (Universitätsklinikum Erlangen, Psychiatrische und Psychotherapeutische Klinik)
Bereich Medizinische Psychologie und Medizinische Soziologie Schwabachanlage 6
Erlangen
91054
Germany

Sponsor information

Organisation

OH-DO-KWAN Stiftung Ludmilla Pankofer und Carl Wiedmeier

Sponsor details

c/o BONJUR Rechtsanwälte
RA Dr. M. Bonefeld
Neuhauser Str. 3
München
80331
Germany

Sponsor type

Charity

Website

http://oh-do-kwan-stiftung.org/index.html

Funders

Funder type

Charity

Funder name

OH-DO-KWAN Stiftung Ludmilla Pankofer und Carl Wiedmeier

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a publically available repository Friedrich-Alexander-Universität Erlangen server and is available upon personal request.

Intention to publish date

01/09/2020

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes