Binge Eating DisorderNCT04876183
Evaluation of a Web-Based Intervention for Binge Eating Disorder
A study testing Selfapy for Binge Eating Disorder in people with Binge Eating Disorder, run by Heidelberg University at 1 site in Germany.
Trial summary
This study evaluates the effectiveness of a web-based intervention specifically designed for patients with Binge Eating Disorder (BED) in a blinded randomized controlled trial. After a sign-up process, a diagnostic interview, and a baseline assessment, eligible participants will be randomly allocated either to (1) an… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- Selfapy for Binge Eating Disorder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteGermany
- Study dates
- 12 Jan 2021to 3 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sufficient German language skills (C1)
- permanent internet access during the study period
- meeting the diagnostic criteria for Binge Eating Disorder according to the Diagnostic- and Statistical Manual of Mental Disorders (DSM-5)
Who cannot join
- current severe depressive episode
- acute suicidality
- comorbid bipolar disorder or psychotic disorders
- acute substance dependence
- current psychotherapy or pharmacotherapy for eating disorders
- Body Mass Index (BMI) below 18.5
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a 12-Week Web-Based Intervention for Binge Eating Disorder: A Randomized Controlled Trial
This study evaluates the effectiveness of a web-based intervention specifically designed for patients with Binge Eating Disorder (BED) in a blinded randomized controlled trial.
After a sign-up process, a diagnostic interview, and a baseline assessment, eligible participants will be randomly allocated either to (1) an intervention group including the online web-based intervention for BED or (2) a waitlist control group with delayed access to the intervention (12 weeks). The program comprises six mandatory weekly sessions and six modular specialization areas resulting in a treatment period of 12 weeks. Minimal guidance is provided via a chat function.
Read more
Assessments will be conducted at pretreatment (study entrance), six weeks after baseline (mid-treatment), and 12 weeks after baseline (post-treatment).
The investigators expect that the intervention group will show lower frequencies of binge eating episodes as the primary outcome variable after the 12 weeks of treatment compared to a waitlist control condition. Moreover, the investigators assume that there will be a higher reduction in global eating disorder symptoms, comorbid psychopathology, and a higher increase in well-being and self-esteem over 12 weeks in the intervention group compared to the waitlist control group.
Finally, the investigators expect that the intervention group will demonstrate a significantly higher reduction in functional impairment, substantially better restoration of work capacity, and an improved ability to regulate emotions after the 12 weeks of treatment.
Read the detailed description
Background: Binge Eating Disorder (BED) is characterized by persistent episodes of uncontrolled eating, associated with marked impairments in physical and mental health, social integration, professional performance, and overall quality of life. Although cognitive-behavioral therapies are effective for Binge Eating Disorder, access to specialized treatment in Germany is limited due to patient-related barriers and insufficient healthcare resources. Internet-based interventions can overcome this treatment gap and reduce the burden of BED for both patients and the healthcare system by making evidence-based interventions more accessible.
Goal: This study evaluates the effectiveness of a web-based intervention specifically designed for patients with BED in a blinded randomized controlled trial.
Method: After a sign-up process, a structured diagnostic interview, and a baseline assessment, eligible participants will be randomly allocated either to (1) an intervention group including the online web-based intervention for BED or (2) a waitlist control group with delayed access to the intervention (12 weeks). The program comprises six mandatory weekly sessions covering topics related to eating behaviors, emotion regulation, and stress management, followed by an optional set of up to six modular specialization areas based on individual therapy goals. Moreover, minimal guidance is included, consisting of technical support and answering questions via a chat function. Assessments will be conducted at pretreatment (study entrance), six weeks after baseline (mid-treatment), and 12 weeks after baseline (post-treatment). The primary outcome will be the number of binge eating episodes. Secondary measures include global eating pathology, comorbid psychopathology, quality of life, self-esteem, emotion regulation, work capacity, and functional impairments.
Statistical Analyses: An intention-to-treat analysis will be performed to examine differences between the intervention and the control group in the change of eating disorder symptoms and secondary outcomes from pre- to post-treatment.
Hypotheses: The investigators expect that the intervention group will show lower frequencies of binge eating episodes as the primary outcome variable after the 12 weeks of treatment compared to a waitlist control condition. The investigators assume that there will be a higher reduction in global eating disorder symptoms, comorbid psychopathology, and a higher increase in well-being and self-esteem over 12 weeks in the intervention group compared to the waitlist control group. Moreover, the investigators expect that the intervention group will demonstrate a significantly higher reduction in functional impairment, substantially better restoration of work capacity, and an improved ability to regulate negative emotions after the 12 weeks of treatment.
- Conditions
- Binge Eating Disorder
- Being tested
- Selfapy for Binge Eating Disorder
- Keywords
- Ecological Momentary Assessment, Internet-based Intervention, Randomized Controlled Trial
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selfapy for Binge Eating DisorderOther
Web-based intervention for Binge Eating Disorder with six mandatory weekly sessions covering topics related to eating behaviors, emotion regulation, and stress management, followed by an optional set of up to six modular specialization areas based on individual therapy goals. During the intervention, participants can access an online chat providing crisis management, answering questions concerning the exercises, and technical support. The chat does not include the opportunity to discuss individual topics and concerns about treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | Web-based intervention (Selfapy for Binge Eating Disorder) Receives: Other: Selfapy for Binge Eating Disorder |
| Waitlist Control Group | No intervention | 12-week waiting period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the frequency of binge eating episodes within the last 28 days
The Eating Disorders Examination Questionnaire (EDE-Q; Berg et al., 2012) captures the frequency of binge eating episodes within the last 28 days using 3 items. Higher values indicate a higher frequency of binge eating episodes.
Measured: 0 weeks, 6 weeks, 12 weeks
Secondary outcomes (12)
Changes in global eating psychopathology
The Eating Disorders Examination Questionnaire (EDE-Q; Berg et al., 2012) allows assessing global eating psychopathology based on 22 items. Mean scores range from 0 to 6, with higher values indicating a higher global eating psychopathology.
Measured: 0 weeks, 6 weeks, 12 weeks
Changes in the weekly frequency of binge eating episodes and regular eating
The Weekly Binges Questionnaire (WBQ; Munsch et al., 2007) assesses the frequency of binge eating episodes, compensatory behavior, and regular eating by asking participants to count the number of binge eating episodes, the number of compensatory behaviors, and the number of days with regular eating habits. While a higher number of binges and compensatory behaviors indicates a higher symptomatology, a higher number of regular eating days indicates a lower symptomatology.
Measured: 0 weeks, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks
Changes in everyday eating disorder symptoms
Ecological momentary assessment (EMA) of eating disorder symptoms (shape concerns, weight concerns, binge eating episodes, urges to eat) for five days (five signal-contingent measurements and additional event-contingent assessments)
Measured: 0 weeks, 12 weeks
Changes in eating-disorder-related daily difficulties
The Clinical Impairment Assessment Questionnaire (CIA; Bohn et al., 2008) consists of 16 items answered on a 4-point Likert scale. The overall score ranges from 0 to 48. Higher values indicate a higher level of clinical impairment.
Measured: 0 weeks, 6 weeks, 12 weeks
Changes in comorbid depressive symptoms
The Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001) consists of 9 items answered on a 4-point scale. The overall score ranges from 0 to 27. Higher values indicate a higher level of depressive symptomology.
Measured: 0 weeks, 6 weeks, 12 weeks
Changes in comorbid anxiety symptoms
The General Anxiety Disorder Scale (GAD-7; Spitzer et al., 2006) consists of 7 items answered on a 4-point scale. The overall score ranges from 0 to 21. Higher values indicate a higher level of anxiety symptoms.
Measured: 0 weeks, 6 weeks, 12 weeks
Changes in well-being
The World Health Organization Well-Being Index (WHO-5; Topp et al., 2015) consists of 5 items answered on a 6-point scale. The overall score ranges from 0 to 100. Higher values indicate a higher level of well-being.
Measured: 0 weeks, 6 weeks, 12 weeks
Changes in self-esteem
The Rosenberg Self-Esteem Scale (RSES; Roth et al., 2008) consists of 10 items answered on a 4-point scale. The overall score ranges from 0 to 30. Higher values indicate a higher level of self-esteem.
Measured: 0 weeks, 6 weeks, 12 weeks
Changes in work capacity
The iMTA Productivity Cost Questionnaire (iPCQ; Bouwmans et al., 2015) consists of 12 items grouped in general questions about paid work and questions about productivity losses in paid and unpaid work. The questionnaire captures the missed work time (paid and unpaid) in hours for short-term absence and calendar days for long-time absence and the hours of lost productivity due to presenteeism.
Measured: 0 weeks, 6 weeks, 12 weeks
Changes in emotion regulation frequencies
The Heidelberg Form for Emotion Regulation Strategies (HFERST; Izadpanah et al., 2019) consists of 28 items answered on a 5-point scale. For each of the eight emotion regulation strategies (rumination, reappraisal, acceptance, problem solving, suppression of emotional expression, suppression of emotional experience, avoidance, social support), a score ranging from 1 to 5 can be calculated. Higher values indicate a higher frequency of emotion regulation strategy endorsement.
Measured: 0 weeks, 6 weeks, 12 weeks
Changes in emotion regulation difficulties
The Difficulties in Emotion Regulation Scale (DERS; Gratz \& Roemer, 2004) consists of 36 items answered on a 5-point scale. The overall score ranges from 36 to 180. Higher values indicate a higher level of emotion regulation difficulties.
Measured: 0 weeks, 6 weeks, 12 weeks
Changes in everyday emotion regulation
Ecological momentary assessment (EMA) of affect, emotion regulation strategies and difficulties for five days (five signal-contingent measurements, and additional event-contingent assessments)
Measured: 0 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start12 Jan 2021
- Primary completion3 Aug 2022
- Study completion3 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with an intervention group and a waiting list control group
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Selfapy GmbH
- Responsible party
- Principal investigator, Christina Timm, Heidelberg University
- Investigators
- Luise Pruessner, Principal investigator, Department of Psychology, Heidelberg UniversityChristina Timm, PhD, Principal investigator, Department of Psychology, Heidelberg UniversitySteffen Hartmann, Principal investigator, Department of Psychology, Heidelberg UniversitySven Barnow, Prof., Principal investigator, Department of Psychology, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876183
- Sponsor's protocol ID
- Selfapy-BED
- Status last verified
- Mar 2025
- First submitted
- 2 May 2021
- Last updated
- 17 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be uploaded after publication of the results.
Publications
Berg KC, Peterson CB, Frazier P, Crow SJ. Psychometric evaluation of the eating disorder examination and eating disorder examination-questionnaire: a systematic review of the literature. Int J Eat Disord. 2012 Apr;45(3):428-38. doi: 10.1002/eat.20931. Epub 2011 Jul 8.
PubMed 21744375Bohn K, Doll HA, Cooper Z, O'Connor M, Palmer RL, Fairburn CG. The measurement of impairment due to eating disorder psychopathology. Behav Res Ther. 2008 Oct;46(10):1105-10. doi: 10.1016/j.brat.2008.06.012. Epub 2008 Jul 2.
PubMed 18710699Bouwmans C, Krol M, Severens H, Koopmanschap M, Brouwer W, Hakkaart-van Roijen L. The iMTA Productivity Cost Questionnaire: A Standardized Instrument for Measuring and Valuing Health-Related Productivity Losses. Value Health. 2015 Sep;18(6):753-8. doi: 10.1016/j.jval.2015.05.009. Epub 2015 Aug 20.
PubMed 26409601Chisholm D, Knapp MR, Knudsen HC, Amaddeo F, Gaite L, van Wijngaarden B. Client Socio-Demographic and Service Receipt Inventory--European Version: development of an instrument for international research. EPSILON Study 5. European Psychiatric Services: Inputs Linked to Outcome Domains and Needs. Br J Psychiatry Suppl. 2000;(39):s28-33. doi: 10.1192/bjp.177.39.s28.
PubMed 10945075Gratz, K. L., & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of psychopathology and behavioral assessment, 26(1), 41-54.
Izadpanah S, Barnow S, Neubauer AB, Holl J. Development and Validation of the Heidelberg Form for Emotion Regulation Strategies (HFERST): Factor Structure, Reliability, and Validity. Assessment. 2019 Jul;26(5):880-906. doi: 10.1177/1073191117720283. Epub 2017 Jul 21.
PubMed 28730850Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Munsch S, Biedert E, Meyer A, Michael T, Schlup B, Tuch A, Margraf J. A randomized comparison of cognitive behavioral therapy and behavioral weight loss treatment for overweight individuals with binge eating disorder. Int J Eat Disord. 2007 Mar;40(2):102-13. doi: 10.1002/eat.20350.
PubMed 17089420Roth, M., Decker, O., Herzberg, P. Y., & Brähler, E. (2008). Dimensionality and norms of the Rosenberg Self-Esteem Scale in a German general population sample. European Journal of Psychological Assessment, 24(3), 190-197.
Rozental A, Kottorp A, Forsstrom D, Mansson K, Boettcher J, Andersson G, Furmark T, Carlbring P. The Negative Effects Questionnaire: psychometric properties of an instrument for assessing negative effects in psychological treatments. Behav Cogn Psychother. 2019 Sep;47(5):559-572. doi: 10.1017/S1352465819000018. Epub 2019 Mar 15.
PubMed 30871650Schroder J, Sautier L, Kriston L, Berger T, Meyer B, Spath C, Kother U, Nestoriuc Y, Klein JP, Moritz S. Development of a questionnaire measuring Attitudes towards Psychological Online Interventions-the APOI. J Affect Disord. 2015 Nov 15;187:136-41. doi: 10.1016/j.jad.2015.08.044. Epub 2015 Aug 28.
PubMed 26331687Schulte D. Patients' outcome expectancies and their impression of suitability as predictors of treatment outcome. Psychother Res. 2008 Jul;18(4):481-94. doi: 10.1080/10503300801932505.
PubMed 18815999Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
PubMed 25831962Pruessner L, Timm C, Barnow S, Rubel JA, Lalk C, Hartmann S. Effectiveness of a Web-Based Cognitive Behavioral Self-Help Intervention for Binge Eating Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e2411127. doi: 10.1001/jamanetworkopen.2024.11127.
PubMed 38753330
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a 12-Week Web-Based Intervention for Binge Eating Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04876183
- Acronym / sponsor ID
- Selfapy-BED
- Conditions
- Binge Eating Disorder
- Keywords
- Ecological Momentary Assessment, Internet-based Intervention, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Selfapy GmbH
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effectiveness of a web-based intervention specifically designed for patients with Binge Eating Disorder (BED) in a blinded randomized controlled trial.
After a sign-up process, a diagnostic interview, and a baseline assessment, eligible participants will be randomly allocated either to (1) an intervention group including the online web-based intervention for BED or (2) a waitlist control group with delayed access to the intervention (12 weeks). The program comprises six mandatory weekly sessions and six modular specialization areas resulting in a treatment period of 12 weeks. Minimal guidance is provided via a chat function.
Assessments will be conducted at pretreatment (study entrance), six weeks after baseline (mid-treatment), and 12 weeks after baseline (post-treatment).
The investigators expect that the intervention group will show lower frequencies of binge eating episodes as the primary outcome variable after the 12 weeks of treatment compared to a waitlist control condition. Moreover, the investigators assume that there will be a higher reduction in global eating disorder symptoms, comorbid psychopathology, and a higher increase in well-being and self-esteem over 12 weeks in the intervention group compared to the waitlist control group.
Finally, the investigators expect that the intervention group will demonstrate a significantly higher reduction in functional impairment, substantially better restoration of work capacity, and an improved ability to regulate emotions after the 12 weeks of treatment.
Detailed description
Background: Binge Eating Disorder (BED) is characterized by persistent episodes of uncontrolled eating, associated with marked impairments in physical and mental health, social integration, professional performance, and overall quality of life. Although cognitive-behavioral therapies are effective for Binge Eating Disorder, access to specialized treatment in Germany is limited due to patient-related barriers and insufficient healthcare resources. Internet-based interventions can overcome this treatment gap and reduce the burden of BED for both patients and the healthcare system by making evidence-based interventions more accessible.
Goal: This study evaluates the effectiveness of a web-based intervention specifically designed for patients with BED in a blinded randomized controlled trial.
Method: After a sign-up process, a structured diagnostic interview, and a baseline assessment, eligible participants will be randomly allocated either to (1) an intervention group including the online web-based intervention for BED or (2) a waitlist control group with delayed access to the intervention (12 weeks). The program comprises six mandatory weekly sessions covering topics related to eating behaviors, emotion regulation, and stress management, followed by an optional set of up to six modular specialization areas based on individual therapy goals. Moreover, minimal guidance is included, consisting of technical support and answering questions via a chat function. Assessments will be conducted at pretreatment (study entrance), six weeks after baseline (mid-treatment), and 12 weeks after baseline (post-treatment). The primary outcome will be the number of binge eating episodes. Secondary measures include global eating pathology, comorbid psychopathology, quality of life, self-esteem, emotion regulation, work capacity, and functional impairments.
Statistical Analyses: An intention-to-treat analysis will be performed to examine differences between the intervention and the control group in the change of eating disorder symptoms and secondary outcomes from pre- to post-treatment.
Hypotheses: The investigators expect that the intervention group will show lower frequencies of binge eating episodes as the primary outcome variable after the 12 weeks of treatment compared to a waitlist control condition. The investigators assume that there will be a higher reduction in global eating disorder symptoms, comorbid psychopathology, and a higher increase in well-being and self-esteem over 12 weeks in the intervention group compared to the waitlist control group. Moreover, the investigators expect that the intervention group will demonstrate a significantly higher reduction in functional impairment, substantially better restoration of work capacity, and an improved ability to regulate negative emotions after the 12 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial with an intervention group and a waiting list control group
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Other: Selfapy for Binge Eating DisorderWeb-based intervention (Selfapy for Binge Eating Disorder) |
| Waitlist Control Group | No intervention | –12-week waiting period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- sufficient German language skills (C1)
- permanent internet access during the study period
- meeting the diagnostic criteria for Binge Eating Disorder according to the Diagnostic- and Statistical Manual of Mental Disorders (DSM-5)
Key exclusion criteria (6 listed)
- current severe depressive episode
- acute suicidality
- comorbid bipolar disorder or psychotic disorders
- acute substance dependence
- current psychotherapy or pharmacotherapy for eating disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selfapy for Binge Eating DisorderWeb-based intervention for Binge Eating Disorder with six mandatory weekly sessions covering topics related to eating behaviors, emotion regulation, and stress management, followed by an optional set of up to six modular specialization areas based on individual therapy goals. During the intervention, participants can access an online chat providing crisis management, answering questions concerning the exercises, and technical support. The chat does not include the opportunity to discuss individual topics and concerns about treatment. | Other | Intervention Group |
Primary outcome
Changes in the frequency of binge eating episodes within the last 28 days
Time frame: 0 weeks, 6 weeks, 12 weeks
The Eating Disorders Examination Questionnaire (EDE-Q; Berg et al., 2012) captures the frequency of binge eating episodes within the last 28 days using 3 items. Higher values indicate a higher frequency of binge eating episodes.
12 secondary outcomes
Changes in global eating psychopathology
Time frame: 0 weeks, 6 weeks, 12 weeks
Changes in the weekly frequency of binge eating episodes and regular eating
Time frame: 0 weeks, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks
Changes in everyday eating disorder symptoms
Time frame: 0 weeks, 12 weeks
Changes in eating-disorder-related daily difficulties
Time frame: 0 weeks, 6 weeks, 12 weeks
Changes in comorbid depressive symptoms
Time frame: 0 weeks, 6 weeks, 12 weeks
Changes in comorbid anxiety symptoms
Time frame: 0 weeks, 6 weeks, 12 weeks
Changes in well-being
Time frame: 0 weeks, 6 weeks, 12 weeks
Changes in self-esteem
Time frame: 0 weeks, 6 weeks, 12 weeks
Changes in work capacity
Time frame: 0 weeks, 6 weeks, 12 weeks
Changes in emotion regulation frequencies
Time frame: 0 weeks, 6 weeks, 12 weeks
Changes in emotion regulation difficulties
Time frame: 0 weeks, 6 weeks, 12 weeks
Changes in everyday emotion regulation
Time frame: 0 weeks, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Background: PubMed 21744375Berg KC, Peterson CB, Frazier P, Crow SJ. Psychometric evaluation of the eating disorder examination and eating disorder examination-questionnaire: a systematic review of the literature. Int J Eat Disord. 2012 Apr;45(3):428-38. doi: 10.1002/eat.20931. Epub 2011 Jul 8.
- Background: PubMed 18710699Bohn K, Doll HA, Cooper Z, O'Connor M, Palmer RL, Fairburn CG. The measurement of impairment due to eating disorder psychopathology. Behav Res Ther. 2008 Oct;46(10):1105-10. doi: 10.1016/j.brat.2008.06.012. Epub 2008 Jul 2.
- Background: PubMed 26409601Bouwmans C, Krol M, Severens H, Koopmanschap M, Brouwer W, Hakkaart-van Roijen L. The iMTA Productivity Cost Questionnaire: A Standardized Instrument for Measuring and Valuing Health-Related Productivity Losses. Value Health. 2015 Sep;18(6):753-8. doi: 10.1016/j.jval.2015.05.009. Epub 2015 Aug 20.
- Background: PubMed 10945075Chisholm D, Knapp MR, Knudsen HC, Amaddeo F, Gaite L, van Wijngaarden B. Client Socio-Demographic and Service Receipt Inventory--European Version: development of an instrument for international research. EPSILON Study 5. European Psychiatric Services: Inputs Linked to Outcome Domains and Needs. Br J Psychiatry Suppl. 2000;(39):s28-33. doi: 10.1192/bjp.177.39.s28.
- BackgroundGratz, K. L., & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of psychopathology and behavioral assessment, 26(1), 41-54.
- Background: PubMed 28730850Izadpanah S, Barnow S, Neubauer AB, Holl J. Development and Validation of the Heidelberg Form for Emotion Regulation Strategies (HFERST): Factor Structure, Reliability, and Validity. Assessment. 2019 Jul;26(5):880-906. doi: 10.1177/1073191117720283. Epub 2017 Jul 21.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 17089420Munsch S, Biedert E, Meyer A, Michael T, Schlup B, Tuch A, Margraf J. A randomized comparison of cognitive behavioral therapy and behavioral weight loss treatment for overweight individuals with binge eating disorder. Int J Eat Disord. 2007 Mar;40(2):102-13. doi: 10.1002/eat.20350.
- BackgroundRoth, M., Decker, O., Herzberg, P. Y., & Brähler, E. (2008). Dimensionality and norms of the Rosenberg Self-Esteem Scale in a German general population sample. European Journal of Psychological Assessment, 24(3), 190-197.
- Background: PubMed 30871650Rozental A, Kottorp A, Forsstrom D, Mansson K, Boettcher J, Andersson G, Furmark T, Carlbring P. The Negative Effects Questionnaire: psychometric properties of an instrument for assessing negative effects in psychological treatments. Behav Cogn Psychother. 2019 Sep;47(5):559-572. doi: 10.1017/S1352465819000018. Epub 2019 Mar 15.
- Background: PubMed 26331687Schroder J, Sautier L, Kriston L, Berger T, Meyer B, Spath C, Kother U, Nestoriuc Y, Klein JP, Moritz S. Development of a questionnaire measuring Attitudes towards Psychological Online Interventions-the APOI. J Affect Disord. 2015 Nov 15;187:136-41. doi: 10.1016/j.jad.2015.08.044. Epub 2015 Aug 28.
- Background: PubMed 18815999Schulte D. Patients' outcome expectancies and their impression of suitability as predictors of treatment outcome. Psychother Res. 2008 Jul;18(4):481-94. doi: 10.1080/10503300801932505.
- Individual participant dataSharing planned: Yes. De-identified data will be uploaded after publication of the results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luise Pruessner principal investigator
Department of Psychology, Heidelberg University
Christina Timm, PhD principal investigator
Department of Psychology, Heidelberg University
Steffen Hartmann principal investigator
Department of Psychology, Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selfapy for Binge Eating Disorder in people with Binge Eating Disorder, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the frequency of binge eating episodes within the last 28 days (time frame: 0 weeks, 6 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04876183, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.