Effectiveness Trial of Temperament Based Therapy With Support (TBT-S)
ConditionAnorexia Nervosa
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOslo University Hospital
About this trial
The main aim of this project is to determine the short and long-term effectiveness of an out-patient treatment for patients with anorexia nervosa. Specifically, we will measure whether TBT-S in addition to treatment as usual (TAU) will be more effective than TAU alone in reducing eating disorder psychopathology. Assessments will be conducted at four timepoints; pre and post TBT-S, and at 3 and 12 months follow-up. Primary outcome measure is eating disorder psychopathology, with the hypothesis that patients receiving TBT-S in addition to TAU will show significantly greater reduction in eating disorder psychopathology from TBT-S treatment admission to 3 month follow-up, compared to controls.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18, all genders
A Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosed anorexia nervosa disorder (F50.0, F50.01, F50.02, also including F50.9 - atypical anorexia nervosa)
Willingness to have Support(s) participate in treatment
Medically stable
Disqualifiers
Intellectual developmental disorder or intellectual disability; psychotic disorder or other psychopathology that may affect or prevent participation in the study
diagnosed alcohol or other substance use disorder within 3 months prior to study initiation
ongoing inpatient treatment at the time of study enrollment (participants currently in inpatient care must be discharged and engaged in outpatient treatment before participating in the TBT-S week
Trial design
Design model
Parallel
Treatments tested in this trial
Temperament Based Therapy with Support (TBT-S)
BehavioralParticipants included in the intervention arm will receive TBT-S (5-day treatment) in addition to treatment as usual (TAU)
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Temperament Based Therapy with Support (TBT-S)Experimental treatment 1 intervention
Group B: Treatment as Usual (TAU)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Eating Disorder Psychopathology
Eating Disorders Examination Questionnaire (EDE-Q). Participants report symptomatology on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology.
Time frame
Baseline, after 1 week and at 3 and 12 months follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov