Plain English Summary
Background and study aims
Anorexia nervosa is an eating disorder where a person keeps their body weight as low as possible. A frequent and characteristic, yet insufficiently studied symptom that can be observed in 31-81% of patients is compulsive exercise. Compulsive exercise is associated with lower short-term response to treatment and poorer long-term outcome. Despite this, no interventions specifically targeting compulsive exercise behavior have been tested so far. An 8-session, manualized group intervention has been developed to promote healthy exercise behavior by both reducing the compulsive quality and excessive quantity of the patients' exercise behavior. After a small study showed promising results, the aim of this study is to test how well this treatment works as add-on to regular inpatient treatment.
Who can participate?
Female patients aged 14-45 with anorexia nervosa and compulsive exercise
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the control group receive routine inpatient treatment. Participants in the intervention group receive the new group intervention as add-on to regular inpatient treatment. This comprises eight sessions (of 100 minutes) and is delivered by a clinical psychologist and a sports therapist. All participants' compulsive exercise behaviour is assessed at admission, before and after the intervention, at discharge and at 6 months after discharge..
What are the possible benefits and risks of participating?
Possible benefits of participating include a stronger reduction of compulsive exercise behavior. The possible risks are not known.
Where is the study run from?
Schön Klinik Roseneck (Germany)
When is the study starting and how long is it expected to run for?
May 2013 to May 2016
Who is funding the study?
Swiss Anorexia Nervosa Foundation
Who is the main contact:?
1. Prof. Ulrich Voderholzer
UVoderholzer@schoen-kliniken.de
2. Mrs Nina Dittmer
NDittmer@schoen-kliniken.de
3. Dr Sandra Schlegl
sandra.schlegl@med.uni-muenchen.de
Trial website
Contact information
Type
Scientific
Primary contact
Prof Ulrich Voderholzer
ORCID ID
Contact details
Schön Klinik Roseneck
Am Roseneck 6
Prien am Chiemsee
83209
Germany
+49 (0)8051 68 100102
UVoderholzer@schoen-kliniken.de
Type
Scientific
Additional contact
Mrs Nina Dittmer
ORCID ID
Contact details
Schön Klinik Roseneck
Am Roseneck 6
Prien am Chiemsee
83209
Germany
+49 (0)8051 68 120422
NDittmer@schoen-kliniken.de
Type
Scientific
Additional contact
Dr Sandra Schlegl
ORCID ID
Contact details
Klinikum der Universität München (LMU)
Klinik für Psychiatrie und Psychotherapie
AG Verhaltenstherapie
Nußbaumstraße 7
München
80336
Germany
+49 (0)89 4400 53369
sandra.schlegl@med.uni-muenchen.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Project no. 26-13 at Swiss Anorexia Nervosa Foundation
Study information
Scientific title
Efficacy of a specialized group intervention for compulsive exercise in inpatients with anorexia nervosa: a randomized controlled trial
Acronym
Study hypothesis
Compared to routine inpatient treatment (treatment as usual), additional participation in the new manualized group intervention "Healthy exercise behavior" (HEB) will result in significantly lower scores in the Commitment to Exercise Scale (CES) at the end of the group (T2).
Ethics approval
Ethics committee of the Ludwig Maximilian University Munich, Germany, 08/05/2013, project number: 060-13
Study design
Single-center interventional randomized superiority trial with two parallel treatment arms
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Anorexia nervosa
Intervention
Randomisation was conducted using randomizer.org (Urbaniak & Plous, 2013). Participants will be randomized to one of two treatment arms:
1. Inpatient routine treatment (treatment as usual=TAU): The specialized inpatient treatment for patients with AN consists of a multimodal cognitive-behavioral approach and intense psychiatric and internistic treatment. All patients receive individual treatment twice per week, a non-specific problem-solving group treatment three times per week and take part in a manualized, symptom-oriented group intervention for eating disorder patients. Furthermore, all AN patients participate in supervised meals three times per day, meal preparation classes, social skills training and art therapy. Patients can also take part in exercise therapy depending on their weight and physical condition. All underweight patients are required to gain at least 700g per week.
2. TAU + participation in the specific group intervention "Healthy exercise behavior" (HEB): The HEB intervention is manual-based, comprises eight sessions (of 100 minutes) and is delivered by a clinical psychologist and a sports therapist. During each session, cognitive-behavioral as well as exercise-based treatment elements complement each other. Between the sessions, patients are required to complete homework tasks. Group sessions are supplemented by individual graded exposure and response prevention tasks concerning exercise behavior guided by one of the therapists.
Measurements are taken at five timepoints: at admission (T0; baseline), before the start of HEB (T1), after the end of HEB (T2), at discharge (T3) and at 6-months after discharge (T4; follow-up).
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Compulsive exercise behavior, measured using the Commitment to Exercise Scale (CES) at admission (T0; baseline), before the start of HEB (T1), after the end of HEB (T2), at discharge (T3) and at 6-months after discharge (T4; follow-up)
Secondary outcome measures
1. Compulsive exercise behavior, measured using the Compulsive Exercise Test
2. Eating disorder psychopathology, measured using the Eating Disorder Inventory-2 and Eating Disorder Examination-Questionnaire
3. General psychopathology, measured using the Beck Depression Inventory-II; Brief Severity Index-18; Obsessive Compulsive Inventory-Revised
4. Emotion regulation skills, measured using the Difficulties in Emotion Regulation Skills Questionnaire
5. BMI, measured by trained and masked nursing staff as part of routine treatment
All outcomes measured after admission (T0; baseline), before the start of HEB (T1), after the end of HEB (T2), before discharge (T3) and at 6-months after discharge (T4; follow-up)
Overall trial start date
01/05/2013
Overall trial end date
08/05/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Female gender
2. DSM-IV diagnosis of AN (DSM-IV 307.1) or atypical AN /EDNOS (DSM-IV 307.50)
3. Presence of compulsive exercise, which was defined based on modified DSM-IV criteria for OCD
3. Age: 14-45 years
Participant type
Patient
Age group
Mixed
Gender
Female
Target number of participants
Minimum of 168 participants
Participant exclusion criteria
1. Body-mass-index (BMI) < 13 kg/m² at the beginning of the Intervention
2. Drug, alcohol or other substance abuse
3. Presence of additional severe psychiatric or neurological disease and suicidality
4. Concurrent treatment for OCD
5. Severe somatic complications, that would prohibit attending a 100 minute group session and/or light to moderate supervised exercise
6. Marked cognitive impairment due to underweight
Recruitment start date
01/10/2013
Recruitment end date
30/06/2015
Locations
Countries of recruitment
Germany
Trial participating centre
Schön Klinik Roseneck
Am Roseneck 6
Prien am Chiemsee
83209
Germany
Sponsor information
Organisation
Schön Klinik Roseneck
Sponsor details
Am Roseneck 6
Prien am Chiemsee
83209
Germany
+49 (0)8051 68 0
UVoderholzer@schoen-kliniken.de
Sponsor type
Hospital/treatment centre
Website
Organisation
Klinikum der Universität München (LMU)
Sponsor details
Klinik für Psychiatrie und Psychotherapie
AG Verhaltenstherapie
Nußbaumstraße 7
München
80336
Germany
+49 (0)89 4400 53369
sandra.schlegl@med.uni-muenchen.de
Sponsor type
University/education
Website
Organisation
TU Dresden
Sponsor details
Department of Clinical Psychology and Psychotherapy
Chemnitzer Straße 46a
Dresden
01187
Germany
Sponsor type
University/education
Website
Organisation
Schön Klinik
Sponsor details
Sponsor type
Not defined
Website
Funders
Funder type
Charity
Funder name
Swiss Anorexia Nervosa Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The trialists intend to submit the first paper for publication in June 2017
IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Ulrich Voderholzer (UVoderholzer@schoen-kliniken.de)
Intention to publish date
01/06/2017
Participant level data
Available on request
Basic results (scientific)
Publication list