Treatment of compulsive exercise in anorexia nervosa
| ISRCTN | ISRCTN14208852 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14208852 |
| Secondary identifying numbers | Project no. 26-13 at Swiss Anorexia Nervosa Foundation |
- Submission date
- 23/03/2017
- Registration date
- 14/07/2017
- Last edited
- 30/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Schön Klinik Roseneck
Am Roseneck 6
Prien am Chiemsee
83209
Germany
| Phone | +49 (0)8051 68 100102 |
|---|---|
| UVoderholzer@schoen-kliniken.de |
Scientific
Schön Klinik Roseneck
Am Roseneck 6
Prien am Chiemsee
83209
Germany
| Phone | +49 (0)8051 68 120422 |
|---|---|
| NDittmer@schoen-kliniken.de |
Scientific
Klinikum der Universität München (LMU)
Klinik für Psychiatrie und Psychotherapie
AG Verhaltenstherapie
Nußbaumstraße 7
München
80336
Germany
| Phone | +49 (0)89 4400 53369 |
|---|---|
| sandra.schlegl@med.uni-muenchen.de |
Study information
| Study design | Single-center interventional randomized superiority trial with two parallel treatment arms |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Efficacy of a specialized group intervention for compulsive exercise in inpatients with anorexia nervosa: a randomized controlled trial |
| Study objectives | 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(s) | Ethics committee of the Ludwig Maximilian University Munich, Germany, 08/05/2013, project number: 060-13 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/05/2013 |
| Completion date | 08/05/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Female |
| Target number of participants | Minimum of 168 participants |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2013 |
| Date of final enrolment | 30/06/2015 |
Locations
Countries of recruitment
- Germany
Study participating centre
Prien am Chiemsee
83209
Germany
Sponsor information
Hospital/treatment centre
Am Roseneck 6
Prien am Chiemsee
83209
Germany
| Phone | +49 (0)8051 68 0 |
|---|---|
| UVoderholzer@schoen-kliniken.de |
University/education
Klinik für Psychiatrie und Psychotherapie
AG Verhaltenstherapie
Nußbaumstraße 7
München
80336
Germany
| Phone | +49 (0)89 4400 53369 |
|---|---|
| sandra.schlegl@med.uni-muenchen.de |
University/education
Department of Clinical Psychology and Psychotherapy
Chemnitzer Straße 46a
Dresden
01187
Germany
Hospital/treatment centre
-
-
-
Germany
| Website | http://www.schoen-kliniken.de/ptp/kkh/ros/ |
|---|---|
"ROR" |
https://ror.org/007ztdc30 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 01/06/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | feasibility and preliminary outcomes | 11/09/2018 | 30/08/2023 | Yes | No |
Editorial Notes
30/08/2023: Publication reference added.
