Abstract
BackgroundContinuous feedback on patient improvement and the therapeutic alliance may reduce the number of dropouts and increase patient outcome. There are, however, only three published randomized trials on the effect of feedback on the treatment of eating disorders, showing inconclusive results, and there are no randomized trials on the effect of feedback in group therapy. Accordingly the current randomized clinical trial, initiated in September 2012 at the outpatient clinic for eating disorders at Stolpegaard Psychotherapy Centre, aims to investigate the impact of continuous feedback on attendance and outcome in group psychotherapy.Methods/designThe hypothesis is that continuous feedback to both patient and therapist on treatment progress and alliance will increase attendance and treatment outcome. The trial is set up using a randomized design with a minimum of 128 patients allocated to either an experimental or control group at a ratio of 1:1. The experimental group will receive standard treatment (systemic and narrative group psychotherapy) with feedback intervention, whereas the control group will receive standard treatment only. The participants are diagnosed with bulimia nervosa, binge eating disorder, or an eating disorder not otherwise specified, according to the DSM-IV. In the experimental group feedback to the participants, based on the Outcome Rating Scale (ORS) and the Group Session Rating Scale (GSRS), is actively added to standard treatment. The ORS assesses areas of life functioning known to change as a result of therapeutic intervention. The GSRS assesses key dimensions of effective therapeutic relationships. In the control group, the patients fill out the Outcome Rating Scale only, and feedback is not provided.The primary outcome is the rate of attendance to treatment sessions. The secondary outcome is the severity of eating disorder symptoms. Exploratory outcomes are the level of psychological and social functioning, and suicide or self-harm. This is measured with the ORS, Symptom Check List, WHO-Five Wellbeing Index, Sheehan Disability Scale and a modified version of the Self-Harm Inventory.DiscussionIf the results will confirm the hypothesis, this trial will support feedback as a way to improve group treatment attendance for outpatients with eating disorders.Trial registrationClinicalTrials.gov identifier: NCT01693237
Highlights
Continuous feedback on patient improvement and the therapeutic alliance may reduce the number of dropouts and increase patient outcome
To obtain the range of plausible bias that may result if the MAR condition is not fulfilled, we will do the following two analyses using single imputations of the outcome performed as a sensitivity analysis: 1) missing values in group A are imputed by the minimum value observed in the material, while missing values in group B are imputed by the maximum value observed, and the two groups are compared; and 2) vice versa
Attendance to psychotherapy is a prerequisite for the therapy to have an effect
Summary
A large proportion of patients end treatment prematurely, which has been associated with poorer treatment outcomes [5,6] In this trial, we hypothesize that integrating patient feedback in the psychotherapy process will increase attendance and patient outcome. The alternative would be to collaborate with a less experienced trainer and/or have less training This solution could imply that the therapists failed to comply with the method or refused to use it, and would pose a greater risk to the trial overall since it would compromise data collection. These two different versions of the ORS might differ in psychometric properties and influence the results [62] This difference is an important premise of the trial design because we hypothesize that the available feedback (from the management system on the tablet computer) will improve attendance and outcome in the experimental groups when compared to the control groups.
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