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

Official title

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

Overview

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.

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.

Interventions

• Behavioral CBT-T
  cognitive behavioral therapy-ten :

Primary outcome measures

• 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]

Secondary outcome measures (2)

• 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]
• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Netherlands · 1 center

• Altrecht Eatings Disorders Rintveld — Zeist

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 27862611

Identifiers

NCT: NCT06790030 · CWO-nr2227

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗