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Eating DisordersNCT06790030

Does Self-Efficacy at the Start of Treatment Influence Treatment Outcome in Patients With EDs?

An observational study of Eating Disorders, run by Altrecht at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Do higher levels of self-efficacy positively predict a more positive treatment outcome? 2. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Eating Disorders
What is being tested?
CBT-T
How many people
50 participants
Where
1 siteNetherlands
Study dates
28 Mar 2023to 1 Dec 2025
How long will I take part?
10 Weeks
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

None listed.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alberte Jansingh, MSc contact

+31306965477

a.jansingh@altrecht.nl

Unna Danner, PhD contact

+31306965477

u.danner@altrecht.nl

Netherlands1 site, 1 recruiting
  • Altrecht Eatings Disorders Rintveld

    Zeist, Utrecht, 3705WE

    Alberte Jansingh, MSc, +31306965477, a.jansingh@altrecht.nl

    Unna Danner, PhD, +31306965477, u.danner@altrecht.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: Does Self-Efficacy at the Start of Treatment Predict Treatment Outcome in Patients With EDs?

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:

Read more
  1. Do higher levels of self-efficacy positively predict a more positive treatment outcome?
  2. Does self-efficacy in itself improve during treatment?
  3. Do autonomous motivation, self-esteem and self-efficacy correlate?

These factors will be measured in patients being treated for their eating disorders with Cognitive Behavior Therapy - Ten (CBT-T).

Researchers will administer questionnaires at start, session four and end of treatment.

Participants will:

  1. Receive their treatment as usual.
  2. fill in questionnaires at the start of treatment, session 4 and end of treatment.
Read the detailed description

Eating disorders (EDs) are severe psychiatric disorders, characterized by a persistent disturbance of eating which impairs health or psychosocial functioning and causes loss of quality of life. There are several evidence-based forms of treatment, but outcomes are mediocre at best. Previous research found better treatment outcomes with several baseline predictors, such as greater motivation to recover. Research on motivation to change has indicated that autonomous motivated (AM) individuals show better response to treatments for EDs. However, being highly motivated for change, but not experiencing the capacity to really eat more and to deal with the emotions evoked by the process of recovery, might lead to difficulty to change key-behaviors, thus leading to less positive treatment outcome. Several researchers emphasized the importance of self-efficacy as a predictor in eating attitudes and behaviors. This study focuses on whether self-efficacy at the start of treatment is predictive of treatment outcome, measured by the ED-15 questionnaire in patients with an ED. Data will be obtained during CBT-T; a brief (10 sessions) version of cognitive behavioral therapy for eating disorders like BN, BED and OSFED. In CBT-T patients are encouraged, from the start of treatment, to challenge their fears, experience the effect of exposure and motivating them to carry through. This aspect might enlarge patients' experience of self-efficacy. Patients with low level of self-efficacy at start, but higher level of self-efficacy after four sessions, might benefit better from treatment, then patients with lower levels of self-efficacy throughout the treatment. To study this potential effect of treatment on self-efficacy, self-efficacy will be measured at start of treatment, at session four and at the end of treatment.

Self-efficacy, self-esteem and autonomous motivation are concepts that are closely linked to each other. To test if they are positively correlated at start of treatment, measurements covering these concepts will be included at T0.

HYPOTHESES

Primary hypotheses:

Higher levels of self-efficacy will positively predict a more positive treatment outcome as determined by lower eating pathology levels with the ED-15.

Secondary hypotheses:

  1. Self-efficacy in itself will improve during treatment.
  2. Autonomous motivation, self-esteem and self-efficacy will be positively correlated.
Being tested
CBT-T
Keywords
treatment, self-efficacy
Medical subject headings
Feeding and Eating Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBT-TBehavioural

    cognitive behavioral therapy-ten :

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. General Self-efficacy

    Dutch General Self-Efficacy Scale (GSES) 10 item self-report to measure self-efficacy. four-point Likert scale, ranging from not at all true (1) to exactly true (4). The total score is calculated by finding the sum of all items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.

    Measured: 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

  2. Coping Self-efficacy

    Coping Self-Efficacy Scale (CSES) The CSES is a 26-item measure of one's confidence in performing coping behavior when facing life challenges. 11-point Likert scale : 0 - "cannot do at all", 5 - "moderately certain can do", and 10 - "certain can do. Item scores are summated to create an overall CSES score (maximum 260). The higher the score, the higher the level of coping self-efficacy

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2025
  2. Study start28 Mar 2023
  3. Primary completion30 Apr 2025 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
Target duration
10 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT06790030
Sponsor's protocol ID
CWO-nr2227
Status last verified
Jan 2025
First submitted
27 Nov 2024
Last updated
23 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 30189116
  • 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.

    PubMed 29417603
  • 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.

    PubMed 26011054
  • 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.

    PubMed 28842966
  • 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.

    PubMed 20721895
  • 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.

    PubMed 30417472
  • 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.

    PubMed 22311824
  • 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.

    PubMed 27862611
  • 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.

    PubMed 30292086
  • 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.

    PubMed 31506978
  • 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.

    PubMed 27567063
  • 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.

    PubMed 25252853
  • 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.

    PubMed 16870053
  • 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.

    PubMed 33915335
  • 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.

    PubMed 26122891

Questions about this trial

What is this clinical trial studying?

An observational study of Eating Disorders, run by Altrecht at 1 site in Netherlands.

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 0 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 23 Jan 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 Netherlands. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alberte Jansingh, MSc (+31306965477, a.jansingh@altrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

treatment outcome (time frame: 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). 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 NCT06790030, which also lists 17 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 23 Jan 2025.

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