Impulsivity-focused group intervention to reduce binge eating episodes in patients with binge eating disorder
Organizational Data
- DRKS-ID:
- DRKS00007689
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2015-01-14
- Last update in DRKS:
- 2023-11-16
- Registration type:
- Prospective
Acronym/abbreviation of the study
IMPULS
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
Binge Eating Disorder (BED) is characterised by recurring episodes of binge eating with a perceived loss of control. Exprimental studies hint that general as well as food-related impulsivity represent a risk factor for BED (cf. Schag, Schönleber et al., 2013; Schag, Teufel et al., 2013). Accordingly, we propose that a behavioral intervention specifically focusing on impulsivity is able to increase the control about impulsive eating behaviour and thus, reduce binge eating episodes, impulsivity and weight in the longterm. In this project, we investigate the efficacy of a manualised impulsivity-focused behavioural modification programme for patients with BED in a randomised controlled trial.
Health condition or problem studied
- ICD10:
- F50.9 - Eating disorder, unspecified
- Free text:
- DSM-5: Binge Eating Disorder
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- experimental group: patients with Binge Eating Disorder participating on the impulsivitry-focused behavioural modification programme. This is a group intervention with 8 weekly sessions á 90 minutes, i.e. the duration of the intervention is 8 weeks.
- Arm 2:
- control group: patients with Binge Eating Disorder who do not participate on the impulsivitry-focused behavioural modification programme.
Endpoints
- Primary outcome:
- The frequency of binge eating episodes within the last 4 weeks at T0 (at the beginning) and T1 (after 8 weeks (at the end of the training period)), assessed by Item 10 of the Eating Disorder Examaniation Interview (Hilbert & Tuschen-Caffier, 2004)
- Secondary outcome:
- Changes between T0 and T1 as well as T1 and T2 (3 months after end of the training period) concerning a) impulsivity: eyetracking variables assessing fodd-related and general impulsivity in the free exploration and antisaccade paradigms, BIS-15 and BIS/BAS questionnaires, b) psychopathology und impulsive eating behaviour by EDE, EDE-Q, BDI II, BMI (kg/m2), DEBQ, YFAS, FCQ-S and FCQ-T, c) Ratings of the valence of the used stimuli in the eye tracking paradigms. Further, we analyse process questionnaires concerning binge eating episodes and impulsive behaviour, weekly assessed between T0 and T1, i.e. eight times and an evaluation questionnaire concerning the impulsivity-focused behavioral modification programme.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Assessor
- Investigator/therapist
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Innere Medizin VI, Psychosomatische Medizin und Psychotherapie Tübingen
Recruitment period and number of participants
- Planned study start date:
- 2015-02-01
- Actual study start date:
- 2015-03-09
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2017-09-30
- Target Sample Size:
- 78
- Final Sample Size:
- 86
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- diagnosis of Binge Eating Disorder according to DSM-5, age about 18, written and informed consent
Exclusion Criteria
1. current bulimia nervosa, current addictive disorders, psychotic disorders, bipolar I disorder, 2. current suicidality, 3. pregnancy, lactation, 4. somatic disorders influencing eating behaviour or weight with altered medication within the last three weeks, 5. current psychotherapeutic treatment of Binge Eating Disorder
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum Tübingen, Innere Medizin VI, Psychosomatische Medizin und PsychotherapieDr. rer. nat. Kathrin SchagOsianderstraße 572076 TübingenGermany
- Telephone:
- 07071-2989117
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.psychosomatik-tuebingen.de/de/index.php
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Tübingen, Innere Medizin VI, Psychosomatische Medizin und PsychotherapieDr. rer. nat. Kathrin SchagOsianderstraße 572076 TübingenGermany
- Telephone:
- 07071-2989117
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.psychosomatik-tuebingen.de/de/index.php
Contact for Public Queries
- Address:
- Universitätsklinikum Tübingen, Innere Medizin VI, Psychosomatische Medizin und PsychotherapieDr. rer. nat. Kathrin SchagOsianderstraße 572076 TübingenGermany
- Telephone:
- 07071-2989117
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.psychosomatik-tuebingen.de/de/index.php
Principal Investigator
- Address:
- Universitätsklinikum Tübingen, Innere Medizin VI, Psychosomatische Medizin und PsychotherapieDr. rer. nat. Kathrin SchagOsianderstraße 572076 TübingenGermany
- Telephone:
- 07071-2989117
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.psychosomatik-tuebingen.de/de/index.php
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Universitätsklinikum Tübingen, AKF-Programm (Angewandte Klinische Forschung) der Medizinischen FakultätGeissweg 372076 TübingenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medizin.uni-tuebingen.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum TübingenGartenstr. 4772074 TübingenGermany
- Telephone:
- +49-7071-2977661
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medizin.uni-tuebingen.de/de/medizinische-fakultaet/ethikkommission
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2014-08-07
- Ethics committee number:
- 471/2014BO2
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2014-09-01
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Schag, K., Leehr, E.J., Becker, S., Zipfel, S., Giel, K.E. (2016). Impulsivitätsbezogene Verhaltensmodifikation zur Reduktion von Essanfällen bei Patienten mit Binge-Eating-Störung – ein Trainingsprogramm für Gruppen. Psychotherapie, Psychosomatik, Medizinische Psychologie 66(11), 449-454.
- Schag, K., Rennhak, S., Leehr, E. J., Skoda, E.-M., Becker, S., Bethge, W., Martus, P., Zipfel, S., Giel, K.E. (2019). IMPULS: Impulsivity-Focused Group Interventionto Reduce Binge Eating Episodes in Patients withBinge Eating Disorder – A Randomised ControlledTrial. Psychother Psychosom, DOI: 10.1159/000499696.
- Schag K, Leehr EJ, Meneguzzo P, Martus P, Zipfel S, Giel KE. Food-related impulsivity assessed by longitudinal laboratory tasks is reduced in patients with binge eating disorder in a randomized controlled trial. Sci Rep. 2021 Apr 15;11(1):8225. doi: 10.1038/s41598-021-87231-w. PMID: 33859214; PMCID: PMC8050257.
- Giel KE, Schurr M, Zipfel S, Junne F, Schag K. Eating behaviour and symptom trajectories in patients with a history of binge eating disorder during COVID-19 pandemic. Eur Eat Disord Rev. 2021 Jul;29(4):657-662. doi: 10.1002/erv.2837. Epub 2021 May 6. PMID: 33955610; PMCID: PMC8206923.
- Ralf Veit, Kathrin Schag, Eric Schopf, Maike Borutta, Jann Kreutzer, Ann-Christine Ehlis, Stephan Zipfel, Katrin E. Giel, Hubert Preissl, Stephanie Kullmann,Diminished prefrontal cortex activation in patients with binge eating disorder associates with trait impulsivity and improves after impulsivity-focused treatment based on a randomized controlled IMPULS trial,NeuroImage: Clinical,Volume 30,2021,102679,ISSN 2213-1582,https://doi.org/10.1016/j.nicl.2021.102679.
- Schag K, Leehr EJ, Martus P, Bethge W, Becker S, Zipfel S, Giel KE. Impulsivity-focused group intervention to reduce binge eating episodes in patients with binge eating disorder: study protocol of the randomised controlled IMPULS trial. BMJ Open. 2015 Dec 18;5(12):e009445. doi: 10.1136/bmjopen-2015-009445. PMID: 26685032; PMCID: PMC4691789. For
- Rennhak SK, Martus P, Zipfel S, Giel KE, Schag K. Process Analyses of Impulsive Behavior in Binge-Eating Disorder During the Randomized Controlled IMPULS Trial. Behav Ther. 2023 Mar;54(2):260-273. doi: 10.1016/j.beth.2022.08.007. Epub 2022 Sep 17. PMID: 36858758.
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- 2019-05-20
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry