i-TREAT: An Internet-based Treatment for Eating Disorders

NCT06239428 | Not Yet Recruiting DMC

• 1 other identifier: 18082179
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study aims to compare the efficacy of an internet-based therapist-guided self-help intervention (named i-TREAT) in reducing eating disorder symptoms in Danish adolescents and adults with Other Specified Feeding or Eating Disorders (OSFED). The study is a randomized controlled trial, comparing the intervention group, receiving i-TREAT, with an active waitlist-control group, receiving online mindfulness material. The investigators hypothesize the intervention group to be superior to the waitlist-control group in terms of 1) reducing eating disorder symptoms and 2) increasing quality of life. The internet-based intervention (i-TREAT) consists of 12 online treatment sessions. It is mainly based on Cognitive Behavior Therapy while inspired by Acceptance and Commitment Therapy. Participants are instructed to complete session-related tasks and receive written feedback from their therapist throughout the treatment. Furthermore, the intervention is also supported by text, illustrations, videos, and a chat function, allowing asynchronous text messaging with the therapist. The treatment courses are expected to run for up to 12 weeks. Participants completing the 12-week waitlist are subsequently offered the i-TREAT intervention. The investigators expect to include 63 participants in each group, who will be recruited through 1) self-referral on the project's website and 2) referral from mental health institutions and doctors.

Conditions

Other Specified Feeding or Eating Disorder; Eating Disorder Nos

Keywords

Eating Disorders; Randomized Controlled Trial; Digital intervention; e-Health; Adolescents; Psychiatry

Outcome Measures

Primary Outcomes (1)

• Eating Disorder Examination Questionnaire (EDE-Q)

  The Eating Disorder Examination Questionnaire (EDE-Q) is a self-report questionnaire assessing the severity and type of eating disorder symptoms and psychopathology during the preceding 28 days. The current version is designed to generate Diagnostic and Statistical Manual of Mental Disorders (DSM-5) compatible eating disorder diagnoses. Finally, the EDE-Q has an excellent internal consistency reliability (Cronbach's α = .95) and is considered the gold standard for measuring eating disorder psychopathology.

  Baseline (Day 0), mid-treatment (up to six weeks), post-treatment (up to 12 weeks), and follow-up (three months)

Secondary Outcomes (3)

• SCOFF Questionnaire

  Baseline (Day 0), mid-treatment (up to six weeks), post-treatment (up to 12 weeks), and follow-up (three months)

• Major Depression Inventory (MDI)

  Baseline (Day 0), mid-treatment (up to six weeks), post-treatment (up to 12 weeks), and follow-up (three months)

• EuroQol - 5 Dimension - 5 Level (EQ-5D-5L)

  Baseline (Day 0), mid-treatment (up to six weeks), post-treatment (up to 12 weeks), and follow-up (three months)

Other Outcomes (7)

• Patient Health Questionnaire (PHQ-9)

  Baseline (Day 0), session 1, session 2, session 3, session 4, session 5, mid-treatment (up to six weeks), session 7, session 8, session 9, session 10, session 11, post-treatment (up to 12 weeks), and follow-up (three months)

• Credibility/Expectancy Questionnaire

  Baseline (Day 0), session 1, session 3, mid-treatment (up to six weeks), session 9

• Compliance

  Session 1, session 2, session 3, session 4, session 5, mid-treatment (up to six weeks), session 7, session 8, session 9, session 10, session 11, post-treatment (up to 12 weeks)

Study Arms (2)

i-TREAT

EXPERIMENTAL

The intervention in the experimental group is an internet-based therapist-guided self-help program, called i-TREAT. The program consists of 12 online treatment sessions. It is mainly based on Cognitive Behavior Therapy while inspired by Acceptance and Commitment Therapy. Participants are instructed to complete session-related tasks and receive written feedback from their therapist throughout the treatment. Furthermore, the intervention is also supported by text, illustrations, videos, and a chat function, allowing asynchronous text messaging with the therapist. The treatment courses are expected to run for 12 weeks.

Behavioral: i-TREAT

Waitlist-control

ACTIVE COMPARATOR

Participants randomized to the active waitlist-control group gains access to online mindfulness material for 12 weeks, however, using the material is non-mandatory. After completing the waitlist, participants are offered the i-TREAT intervention. The active waitlist was implemented to prevent potential adverse effects of being on a passive waitlist (which currently comes closest to treatment as usual since no other treatment modalities exist for the target group in the Danish psychiatry).

Other: Waitlist

Interventions

i-TREAT BEHAVIORAL

A 12-session internet-based cognitive behavioral intervention for Danish adolescents and adults with Other Specified Feeding or Eating Disorders.

i-TREAT

Waitlist OTHER

A 12-week waitlist with access to online mindfulness material.

Waitlist-control

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 15 to 17 years, or age ≥ 18 years.
• Fulfilment of the diagnostic criteria for Other Specified Feeding or Eating Disorders according to DSM-V and ICD-11.
• Comprehension of the Danish language.
• Consent from at least one parent for participants between 15 to 17 years.
• Access to the Danish secure mail system E-boks.

You may not qualify if:

• Body Mass Index (BMI) ≤ 17,5.
• Lack of access to technological device (computer and tablet/iphone/android).
• Concurrent participation in other psychotherapeutic treatment.
• Concurrent diagnosis of severe depression, severe anxiety, or substance dependence disorder.
• Previously diagnosed with psychosis or Autism Spectrum Disorder.
• If on medication, medication must be stable for six months prior to, as well as during, the study participation (i.e., no changes in type of medication or dosage).

Sponsors & Collaborators

• Region of Southern Denmark: lead
• JaschaFonden: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Centre for Digital Psychiatry

Odense, Region Syddanmark, 5000, Denmark

Location

Related Publications (21)

• Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.

  PMID: 7866415 BACKGROUND

• Fairburn, C. G. (2008). Cognitive Behavior Therapy and Eating Disorders. Guilford Press.

  BACKGROUND

• World Health Organization (1992). The ICD-10 Classification of Mental and Behavioural Disorders. Clinical descriptions and diagnostic guidelines. World Health Organization.

  BACKGROUND

• Aardoom JJ, Dingemans AE, Slof Op't Landt MC, Van Furth EF. Norms and discriminative validity of the Eating Disorder Examination Questionnaire (EDE-Q). Eat Behav. 2012 Dec;13(4):305-9. doi: 10.1016/j.eatbeh.2012.09.002. Epub 2012 Sep 19.

  PMID: 23121779 BACKGROUND

• Botella J, Sepulveda AR, Huang H, Gambara H. A meta-analysis of the diagnostic accuracy of the SCOFF. Span J Psychol. 2013;16:E92. doi: 10.1017/sjp.2013.92.

  PMID: 24230955 BACKGROUND

• Lichtenstein MB, Hemmingsen SD, Stoving RK. Identification of eating disorder symptoms in Danish adolescents with the SCOFF questionnaire. Nord J Psychiatry. 2017 Jul;71(5):340-347. doi: 10.1080/08039488.2017.1300322. Epub 2017 Mar 14.

  PMID: 28290749 BACKGROUND

• Bech, P. (2012). Clinical Psychometrics. John Wiley & Sons, Ltd.

  BACKGROUND

• Feng YS, Kohlmann T, Janssen MF, Buchholz I. Psychometric properties of the EQ-5D-5L: a systematic review of the literature. Qual Life Res. 2021 Mar;30(3):647-673. doi: 10.1007/s11136-020-02688-y. Epub 2020 Dec 7.

  PMID: 33284428 BACKGROUND

• Kroenke 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.

  PMID: 11556941 BACKGROUND

• Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.

  PMID: 11132119 BACKGROUND

• Nielsen, M. D., Andreasen, C., & Thastum, M. (2016). A Danish study of One-session Treatment for Specific Phobias in Children and Adolescents. Scandinavian Journal of Child and Adolescent Psychiatry and Psychology, 4, 65-76. https://doi.org/10.21307/sjcapp-2016-011

  BACKGROUND

• Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.

  PMID: 10245370 BACKGROUND

• Schmidt NB, Woolaway-Bickel K. The effects of treatment compliance on outcome in cognitive-behavioral therapy for panic disorder: quality versus quantity. J Consult Clin Psychol. 2000 Feb;68(1):13-8. doi: 10.1037//0022-006x.68.1.13.

  PMID: 10710836 BACKGROUND

• 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.

  PMID: 30871650 BACKGROUND

• Brooke, J. (1996). SUS: A

  BACKGROUND

• Atwood ME, Friedman A. A systematic review of enhanced cognitive behavioral therapy (CBT-E) for eating disorders. Int J Eat Disord. 2020 Mar;53(3):311-330. doi: 10.1002/eat.23206. Epub 2019 Dec 16.

  PMID: 31840285 BACKGROUND

• ter Huurne ED, Postel MG, de Haan HA, DeJong CA. Effectiveness of a web-based treatment program using intensive therapeutic support for female patients with bulimia nervosa, binge eating disorder and eating disorders not otherwise specified: study protocol of a randomized controlled trial. BMC Psychiatry. 2013 Nov 16;13:310. doi: 10.1186/1471-244X-13-310.

  PMID: 24238630 BACKGROUND

• Andersson G. Internet-Delivered Psychological Treatments. Annu Rev Clin Psychol. 2016;12:157-79. doi: 10.1146/annurev-clinpsy-021815-093006. Epub 2015 Dec 11.

  PMID: 26652054 BACKGROUND

• Ter Huurne ED, de Haan HA, Postel MG, DeJong CAJ, VanDerNagel JEL, van der Palen J. Long-term effectiveness of web-based cognitive behavioral therapy for patients with eating disorders. Eat Weight Disord. 2021 Apr;26(3):911-919. doi: 10.1007/s40519-020-00929-0. Epub 2020 May 24.

  PMID: 32449152 BACKGROUND

• Strandskov SW, Ghaderi A, Andersson H, Parmskog N, Hjort E, Warn AS, Jannert M, Andersson G. Effects of Tailored and ACT-Influenced Internet-Based CBT for Eating Disorders and the Relation Between Knowledge Acquisition and Outcome: A Randomized Controlled Trial. Behav Ther. 2017 Sep;48(5):624-637. doi: 10.1016/j.beth.2017.02.002. Epub 2017 Mar 2.

  PMID: 28711113 BACKGROUND

• Ruwaard J, Lange A, Broeksteeg J, Renteria-Agirre A, Schrieken B, Dolan CV, Emmelkamp P. Online cognitive-behavioural treatment of bulimic symptoms: a randomized controlled trial. Clin Psychol Psychother. 2013 Jul-Aug;20(4):308-18. doi: 10.1002/cpp.1767. Epub 2012 Feb 1.

  PMID: 22298417 BACKGROUND

MeSH Terms

Conditions

Feeding and Eating Disorders

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Marie P Folker, Cand.scient.

  Centre for Digital Psychiatry

  STUDY CHAIR

Central Study Contacts

Eik Runge, Cand.psych.

CONTACT

+45 2180 9853; Eik.Runge@rsyd.dk

Mia B Lichtenstein, Cand.psych.

CONTACT

+45 9944 8681; mlichtenstein@health.sdu.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 2, 2024
• Study Start: September 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available once the study ends ultimo 2026.
• Access Criteria: The data can be accessed through open access supplementary material or upon request from the corresponding author(s).

Locations

DK (1)