Primary Objective: a) piloting the intervention- to identify whether DBI is feasible and acceptable (tolerability, appropriateness, usefulness) being studied from both the perspective of study participants, the research team and clinicians, and…
ID
Source
Brief title
Condition
- Eating disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Qualitative and quantitative assessment of acceptability, satisfaction, and
feasibility collected from participants, clinicians and the research team,
focusing on the intervention and on the conduct of the trial.
Secondary outcome
Changes in self-objectification, thin-ideal internalization, body
dissatisfaction, eating disorder pathology, and depressive and anxiety
symptomatology.
Background summary
Eating disorders are difficult to treat; even after successful treatment
relapse is a significant problem with rates ranging from 22% to 51% across
outcome studies of anorexia and bulimia nervosa (Eckert, 1995; Herzog, 1999;
Keel, 2005). As a result, efforts have been devoted to development of
interventions that can prevent the onset of eating disorders. Dissonance based
(prevention) intervention has received the greatest amount of empirical support
(DBI; Stice, Shaw, Becker, & Rohde, 2008). DBI identifies body dissatisfaction
as one of the leading risk and maintenance factors of eating disorders. Indeed,
body dissatisfaction is a key diagnostic feature of anorexia nervosa and
bulimia nervosa, and continued body dissatisfaction is found to be a major
predictor of relapse in patients treated for anorexia nervosa and bulimia
nervosa (Keel, 2005). Thus, to improve outcomes in the treatment of eating
disorders, adjunctive strategies are needed that target body dissatisfaction.
DBI makes use of cognitive dissonance to address thin-ideal internalization,
body dissatisfaction, and eating disorder symptoms. The theory of cognitive
dissonance proposes that when there is an inconsistency between an individual*s
beliefs and behaviours, the resulting discomfort will motivate them to change
their attitude or behaviours to reduce this inconsistency (Festinger, 1957).
More specifically, in DBI women with body image concerns voluntarily and
actively engage in verbal, written and behavioural exercises in which they
challenge beliefs about the thin-ideal.
A great deal of evidence supports DBI as an effective preventive treatment
(Becker, Smith, & Ciao, 2005; Green, Scott, Diyankova, Gassner, & Pederson,
2005; Matusek, Wendt & Wiseman, 2004; Mitchell, Mazzeo, Rausch, & Cooke, 2007;
Roehrig, Thompson, Brannick, & van den Berg, 2006; Stice, Chase, Stormer, &
Appel, 2001). Moreover, Stice, Rohde, Butryn, Menke, and Marti (2015) found
preliminary support for the use of modified DBI as a stand-alone group
treatment for people already diagnosed with an eating disorder.
Evidence for DBI for full-blown eating disorders is still preliminary and has
not focused on a treatment-seeking population with more severe and therefore
also possibly a different type of eating disorder pathology. Given the
heterogeneity of the patient group and the complexity of the typically
comprehensive treatment and infrastructure within and across eating disorders
centers, the goal of the currently proposed study is not only to investigate
preliminary effectiveness of the intervention, but also to test the feasibility
and acceptability of DBI.
The two primary objectives of the proposed study are therefore to identify
whether DBI is feasible and acceptable (tolerability, appropriateness,
usefulness) being studied from both the perspective of study participants, the
research team, and clinicians, to determine any necessary modifications, and to
test procedures for a future RCT. Additionally, patients will complete
standardized questionnaires to preliminary investigate effectiveness of DBI,
which comprises the secondary objective of the currently proposed study.
Study objective
Primary Objective: a) piloting the intervention- to identify whether DBI is
feasible and acceptable (tolerability, appropriateness, usefulness) being
studied from both the perspective of study participants, the research team and
clinicians, and determine any necessary modifications; b) piloting the trial
processes- to test procedures for a future pilot/ definitive RCT, especially in
relation to eligibility criteria, recruitment and retention rates.
Secondary Objective(s): preliminary testing the effectiveness of DB I- to
systematically assess changes in all variables that appear in the models of
self-objectification theory and the dual pathway model - self-objectification,
thin-ideal internalization, body dissatisfaction, negative affect and eating
disorder pathology. Analyses regarding effectiveness will be exploratory.
Study design
Randomized pilot controlled study comparing dissonance based intervention to
psycho-education, both in addition to TAU.
Intervention
Patients are randomized to either receive dissonance based intervention or
psycho-education, both in addition to TAU.
Study burden and risks
There are no evident risks involved for participants.
Molierelaan 1
Eindhoven 5629 PG
NL
Molierelaan 1
Eindhoven 5629 PG
NL
Listed location countries
Age
Inclusion criteria
Patients diagnosed with Anorexia Nervosa, Bulimia Nervosa and EDNOS (BED excluded)
Exclusion criteria
Male, BED, schizophrenia or other psychotic disorders, substance abuse
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL60165.091.17 |