Condition category
Mental and Behavioural Disorders
Date applied
23/03/2017
Date assigned
14/07/2017
Last edited
24/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes