NCT06790030

Brief Summary

The goal of this clinical trial is to contribute to the improvement of treatment for eating disorders, by identifying factors that might positively affect treatment outcome. The main questions it aims to answer are:

  1. 1.Do higher levels of self-efficacy positively predict a more positive treatment outcome?
  2. 2.Does self-efficacy in itself improve during treatment?
  3. 3.Do autonomous motivation, self-esteem and self-efficacy correlate?
  4. 4.Receive their treatment as usual.
  5. 5.fill in questionnaires at the start of treatment, session 4 and end of treatment.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 23, 2025

Status Verified

January 1, 2025

Enrollment Period

2.1 years

First QC Date

November 27, 2024

Last Update Submit

January 22, 2025

Conditions

Keywords

treatmentself-efficacy

Outcome Measures

Primary Outcomes (1)

  • treatment outcome

    Eating Disorder-15 (ED-15) is a self-report questionnaire used to measure session-by-session change in eating pathology as part of the CBT-T protocol. All items are positively scored from 0-6, with higher scores reflecting higher levels of eating disorder pathology.

    CBT-T is a weekly, ten-session treatment. The ED-15 will be adminstered at the start of the first treatment session, at session 4 and at the end of treatment (session 10).: * week 1 * week 4 * week 10

Secondary Outcomes (2)

  • General Self-efficacy

    CBT-T is a weekly, ten-session treatment. The GSES will be adminstered at at the start of the first treatment session , at session 4 and at the end of treatment (session 10): * week 1 * week 4 * week 10

  • Coping Self-efficacy

    CBT-T is a weekly, ten-session treatment. The CSES will be adminstered at the start of the first treatment session , at session 4 and at the end of treatment (session 10): * week 1 * week 4 * week 10

Other Outcomes (3)

  • Autonomous motivation

    CBT-T is a weekly, ten-session treatment. The ACMTQ will be adminstered at the start of the first treatment session: *week 1

  • Self-esteem

    CBT-T is a weekly, ten-session treatment. The RSES will be adminstered at the start of the first treatment session: *week 1

  • Motivation

    CBT-T is a weekly, ten-session treatment. The Motivational Ruler will be adminstered at the start of the first treatment session: * week 1.

Interventions

CBT-TBEHAVIORAL

cognitive behavioral therapy-ten :

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

(adult) Patients treated for eatingdisorders with CBT-T at Altrecht Eating Disorders Rintveld or at Co-eur.

You may qualify if:

  • Participants must be 18 years or older
  • Having an eating disorder diagnosed according to the Diagnostic Statistical Manual (DSM-5)
  • Starting CBT-T treatment

You may not qualify if:

  • Intellectual disability according to the Diagnostic Statistical Manual (DSM-5) or an IQ below 80
  • Inability to speak or read Dutch
  • Patients treated under a legal act

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altrecht Eatings Disorders Rintveld

Zeist, Utrecht, 3705WE, Netherlands

RECRUITING

Related Publications (17)

  • Denison-Day J, Appleton KM, Newell C, Muir S. Improving motivation to change amongst individuals with eating disorders: A systematic review. Int J Eat Disord. 2018 Sep;51(9):1033-1050. doi: 10.1002/eat.22945. Epub 2018 Sep 6.

    PMID: 30189116BACKGROUND
  • Waller G, Tatham M, Turner H, Mountford VA, Bennetts A, Bramwell K, Dodd J, Ingram L. A 10-session cognitive-behavioral therapy (CBT-T) for eating disorders: Outcomes from a case series of nonunderweight adult patients. Int J Eat Disord. 2018 Mar;51(3):262-269. doi: 10.1002/eat.22837. Epub 2018 Feb 8.

    PMID: 29417603BACKGROUND
  • Tatham M, Turner H, Mountford VA, Tritt A, Dyas R, Waller G. Development, psychometric properties and preliminary clinical validation of a brief, session-by-session measure of eating disorder cognitions and behaviors: The ED-15. Int J Eat Disord. 2015 Nov;48(7):1005-15. doi: 10.1002/eat.22430. Epub 2015 May 26.

    PMID: 26011054BACKGROUND
  • Steiger H, Sansfacon J, Thaler L, Leonard N, Cottier D, Kahan E, Fletcher E, Rossi E, Israel M, Gauvin L. Autonomy support and autonomous motivation in the outpatient treatment of adults with an eating disorder. Int J Eat Disord. 2017 Sep;50(9):1058-1066. doi: 10.1002/eat.22734. Epub 2017 Jun 14.

    PMID: 28842966BACKGROUND
  • Steele AL, Bergin J, Wade TD. Self-efficacy as a robust predictor of outcome in guided self-help treatment for broadly defined bulimia nervosa. Int J Eat Disord. 2011 Jul;44(5):389-96. doi: 10.1002/eat.20830. Epub 2010 Aug 18.

    PMID: 20721895BACKGROUND
  • Sansfacon J, Fletcher E, Zuroff DC, Schmitz N, Miller A, Israel M, Steiger H. Psychometric properties of the "Autonomous and Controlled Motivation for Treatment Questionnaire" in women with eating disorders. Eur Eat Disord Rev. 2019 May;27(3):306-314. doi: 10.1002/erv.2656. Epub 2018 Nov 12.

    PMID: 30417472BACKGROUND
  • Mansour S, Bruce KR, Steiger H, Zuroff DC, Horowitz S, Anestin AS, Sycz L. Autonomous motivation: a predictor of treatment outcome in bulimia-spectrum eating disorders. Eur Eat Disord Rev. 2012 May;20(3):e116-22. doi: 10.1002/erv.2154. Epub 2012 Feb 7.

    PMID: 22311824BACKGROUND
  • Linardon J, de la Piedad Garcia X, Brennan L. Predictors, Moderators, and Mediators of Treatment Outcome Following Manualised Cognitive-Behavioural Therapy for Eating Disorders: A Systematic Review. Eur Eat Disord Rev. 2017 Jan;25(1):3-12. doi: 10.1002/erv.2492. Epub 2016 Nov 16.

    PMID: 27862611BACKGROUND
  • Hasking P, Boyes M, Greves S. Self-efficacy and emotionally dysregulated behaviour: An exploratory test of the role of emotion regulatory and behaviour-specific beliefs. Psychiatry Res. 2018 Dec;270:335-340. doi: 10.1016/j.psychres.2018.09.045. Epub 2018 Sep 20.

    PMID: 30292086BACKGROUND
  • Hamadi L, Holliday J. Moderators and mediators of outcome in treatments for anorexia nervosa and bulimia nervosa in adolescents: A systematic review of randomized controlled trials. Int J Eat Disord. 2020 Jan;53(1):3-19. doi: 10.1002/eat.23159. Epub 2019 Sep 11.

    PMID: 31506978BACKGROUND
  • Eisenberg MH, Lipsky LM, Dempster KW, Liu A, Nansel TR. I Should but I Can't: Controlled Motivation and Self-Efficacy Are Related to Disordered Eating Behaviors in Adolescents With Type 1 Diabetes. J Adolesc Health. 2016 Nov;59(5):537-542. doi: 10.1016/j.jadohealth.2016.06.008. Epub 2016 Aug 23.

    PMID: 27567063BACKGROUND
  • Clarke J, Proudfoot J, Birch MR, Whitton AE, Parker G, Manicavasagar V, Harrison V, Christensen H, Hadzi-Pavlovic D. Effects of mental health self-efficacy on outcomes of a mobile phone and web intervention for mild-to-moderate depression, anxiety and stress: secondary analysis of a randomised controlled trial. BMC Psychiatry. 2014 Sep 26;14:272. doi: 10.1186/s12888-014-0272-1.

    PMID: 25252853BACKGROUND
  • Chesney MA, Neilands TB, Chambers DB, Taylor JM, Folkman S. A validity and reliability study of the coping self-efficacy scale. Br J Health Psychol. 2006 Sep;11(Pt 3):421-37. doi: 10.1348/135910705X53155.

    PMID: 16870053BACKGROUND
  • Chang PGRY, Delgadillo J, Waller G. Early response to psychological treatment for eating disorders: A systematic review and meta-analysis. Clin Psychol Rev. 2021 Jun;86:102032. doi: 10.1016/j.cpr.2021.102032. Epub 2021 Apr 18.

    PMID: 33915335BACKGROUND
  • Bruijniks SJ, Bosmans J, Peeters FP, Hollon SD, van Oppen P, van den Boogaard M, Dingemanse P, Cuijpers P, Arntz A, Franx G, Huibers MJ. Frequency and change mechanisms of psychotherapy among depressed patients: study protocol for a multicenter randomized trial comparing twice-weekly versus once-weekly sessions of CBT and IPT. BMC Psychiatry. 2015 Jun 30;15:137. doi: 10.1186/s12888-015-0532-8.

    PMID: 26122891BACKGROUND
  • Bosscher RJ, Smit JH. Confirmatory factor analysis of the General Self-Efficacy Scale. Behav Res Ther. 1998 Mar;36(3):339-43. doi: 10.1016/s0005-7967(98)00025-4.

    PMID: 9642852BACKGROUND
  • Bardone-Cone AM, Thompson KA, Miller AJ. The self and eating disorders. J Pers. 2020 Feb;88(1):59-75. doi: 10.1111/jopy.12448. Epub 2018 Dec 30.

    PMID: 30506587BACKGROUND

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Alberte Jansingh, MSc

CONTACT

Unna Danner, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical psychologist; Lead Expert Eatingdisorders Altrecht

Study Record Dates

First Submitted

November 27, 2024

First Posted

January 23, 2025

Study Start

March 28, 2023

Primary Completion

April 30, 2025

Study Completion

December 1, 2025

Last Updated

January 23, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

data will be profided in case of a specific request. Data will be stored anonymously in a database on a special drive for scientific research at Altrecht. Researchers will act according to the Declaration of Helsinki, version 59th WMA General Assembly, October 2008. All study data will be stored in a coded way and the key-to-the-name information will be stored in a separate file which will only be accessible to researchers directly involved in the study. The data will be handled confidently and anonymously and will be stored for at least 15 years, in line with the article 454 section 3 from "Wet op de Geneeskundige Behandelingsovereenkomst - WGBO". Only the researchers who are directly involved in this project will have access to the data. The data will be described at group level. All data will be handled and described within the Altrecht workspace.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
for the next 15 years
Access Criteria
information can be obtained by contacten the researchers.

Locations