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Concurrent Treatment for Patients with Severe Anorexia Nervosa and Post-Traumatic Stress Disorder: A Feasibility Study

Concurrent Treatment for Patients with Severe Anorexia Nervosa and Post-Traumatic Stress Disorder: A Feasibility Study - Cocoon Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56517
Enrollment
11
Registered
2023-12-05
Start date
2023-02-08
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-traumatische stress-stoornis anorexia anorexia nervosa

Interventions

Individual CBT-based trauma-focused treatment (IE) for 8 weeks, twice a week, will be offered by specialized trauma therapists, during a 12-weeks hospitalization period for AN in a specialized eating

Sponsors

Arkin (Amsterdam)
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: The study sample consists of consecutive referrals by general practitioners or general hospitals with adult patients with severe anorexia nervosa (AN) and (subthreshold) posttraumatic stress disorder (PTSD). Patients are eligible if they meet all of the following criteria: •Being over 18 years of age •A DSM-5 diagnosis of AN with a body mass index under 17.5 kg/m2 , as assessed by a psychiatrist or clinical psychologist. These AN patients have been offered and accepted inpatient treatment •Being exposed to childhood maltreatment prior to the onset of the eating disorder, as assessed by the Dutch version of the Childhood Trauma Questionnaire (CTQ; Thombs et al., 2009) •Having a diagnosis of PTSD or sub-threshold PTSD as assessed by the Dutch version of the Clinical-Administered PTSD Scale for DSM-5 (CAPS; Boeschoten et al., 2018) defined as having two or three of the DSM-5 criteria B - E •Agrees to terms and conditions of the study and has provided informed consent •Dutch speaking

Exclusion criteria

Exclusion criteria: Acute suicidal or psychotic decompensation

Design outcomes

Primary

MeasureTime frame
Feasibility will be assessed by examining by assessing attrition rate and by assessing trauma treatment acceptability. The primary outcome measure is attrition rate (percentage of participants who stop out or are withdrawn of the trauma-focused treatment due to negative effect on the course of AN treatment. Negative effects on the AN treatment can be not being able to stick to agreed daily meal plans anymore or for stopping regaining weight. If attrition is attrition is

Secondary

MeasureTime frame
The secondary outcomes in this study are factors that may moderate attrition, including duration of anorexia, AN subtype and AN onset, baseline BMI (kg/m2), somatic disorders and emotion regulation measured using the Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004). It is suspected that these factors may moderate attrition. Other secondary outcomes include treatment effects such as changes in eating disorder pathology measured using the Eating Disorder Examination Interview (Cooper &; Fairburn, 1987) and changes in trauma pathology measured using the PTSD Checklist for DSM-5 (PCL-5). In addition, other measures will assess the acceptability of combined treatment. To measure the acceptability of the AN-PTSD treatment, a qualitative interview will take place in which patients will be asked about their experiences. Practitioners are also interviewed about their experiences before and after treatment. Client satisfaction will be measured using the client satisfaction questionnaire (CSQ-8; de Brey, 1983) at the end of the IE treatment and at the end of the AN treatment. Finally, the Working Alliance Inventory (WAI; Hatcher & Gillaspy, 2016) will be used to examine patients' therapeutic alliance.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)