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NCT Number: NCT06790030

Does Self-Efficacy at the Start of Treatment Influence 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:

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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:

  • Self-efficacy in itself will improve during treatment.
  • Autonomous motivation, self-esteem and self-efficacy will be positively correlated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients are eligible for participation when they meet the following inclusion criteria:

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

Exclusion criteria

  • 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

Treatment and study plan

CBT-t

Behavioral

cognitive behavioral therapy-ten :

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. General Self-efficacy

    Time frame: 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

    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.

  2. Coping Self-efficacy

    Time frame: 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

    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

Other outcomes

  1. Autonomous motivation

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

    Autonomous and Controlled Motivation for Treatment Questionnaire (ACMTQ) - Dutch Translation, adjusted to ED population by replacing the word depression to eating disorders.

    The seven-point Likert scale ranges from 1 (strongly disagree) to 7 (strongly agree). Two mean scores are derived, one per subscale. Higher scores indicate stronger endorsement of the motivation type.

  2. Self-esteem

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

    Rosenberg Self-Esteem Scale (RSES), 10-item scale, four-point Likert scale format, ranging from strongly agree to strongly disagree. Higher scores indicate higher self-esteem.

  3. Motivation

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

    Motivational Ruler Identifies the ability to change and importance to change; range 0-10). Higher scores reflect a higher motivation to change.

Study contacts

Contact information is provided by the study sponsor or research team.

Alberte Jansingh, MSc

CONTACT

[email protected]

+31306965477

Unna Danner, PhD

CONTACT

[email protected]

+31306965477

Sponsors and collaborators

Lead sponsor

Altrecht

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2025
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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