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This clinical trial employs a two-fold approach, utilizing a single-arm feasibility design within a larger multiple baseline experimental case series study framework over 32 weeks. The study aims to investigate both the feasibility and efficacy of Radically Open Dialectical Behaviour Therapy (RO-DBT) in patients with anorexia nervosa (AN). Feasibility will be assessed through treatment retention, data collection engagement, patient satisfaction, and the occurrence of adverse events. Efficacy outcomes will focus on RO-DBT's impact on ED psychopathology, obsessive-compulsive personality traits, EDR, and BMI.
Anorexia nervosa (AN) is characterized by high chronicity and mortality rates. Despite its relatively high prevalence, effective treatments remain elusive, often resulting in extended treatment durations and high dropout rates. Emotional dysregulation (EDR) and obsessive-compulsive personality traits are central to the psychopathology of AN, directly contributing to the disorder's severity and persistence. Radically Open Dialectical Behaviour Therapy (RO-DBT) targets the psychopathology mentioned above and has shown promise in pilot studies with AN patients.
Given the urgent need for effective AN treatments and the potential of RO-DBT, this study aims to investigate both the feasibility and efficacy of this therapy in a clinical setting. The study will employ a single-arm feasibility design within a multiple baseline experimental case series framework over 32 weeks, involving 31 patients aged 16 years and older diagnosed with typical or atypical AN. All assessments will utilize validated psychometric instruments, and trained psychotherapists will administer RO-DBT.
Feasibility will be assessed through:
The primary efficacy outcome this trial aims to investigate is:
* Does RO-DBT reduce eating disorder psychopathology in AN as measured by the Eating Disorder Examination Questionnaire (EDE-Q)?
The secondary efficacy outcomes this trial aims to investigate are:
We hypothesize that RO-DBT will be a feasible treatment option for individuals with AN. Furthermore, we anticipate observing reductions in ED psychopathology and expressive suppression, alongside an increase in BMI, between pre- and post-treatment assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radically Open Dialectical Behaviour Therapy (RO-DBT) | Experimental | RO-DBT consists of a 1 hour weekly individual session and a 2,5 hour weekly group skill training during 32 weeks in accordance with the published treatment manual and session guides for RO-DBT. For skills training, the 31 patients will be divided into four equal groups in terms on number. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radically Open Dialectical Behaviour Therapy (RO-DBT) | Behavioral | RO-DBT is a trans diagnostic intervention specifically designed to treat a spectrum of disorders characterized by excessive overcontrol such as anorexia nervosa, autism spectrum disorder, refractory depression, cluster c personality disorders, and mood disorders. |
| Measure | Description | Time Frame |
|---|---|---|
| The Eating Disorder Examination Questionnaire (EDE-Q) | A 36-item self-report questionnaire designed to measure eating disorder symptoms. The range of scores is 0-132. Higher scores mean more eating disorder symptoms | 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Five Factor Obsessive Compulsive Inventory - Short Form (FFOCI-SF) | A 48-item self-report questionnaire designed to measure obsessive-compulsive personality traits. The range of scores is 48-240. Higher scores mean more obsessive-compulsive personality traits. | 32 weeks |
| The Emotion Regulation Questionnaire (ERQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magnus Sjögren, PhD | Umea University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sundsvalls sjukhus, Lasarettsvagen 21 | Sundsvall | Västernorrland County | 856 43 | Sweden |
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| Label | URL |
|---|---|
| Related link | View source |
| Related link | View source |
| Related link |
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A 10-item self-report questionnaire designed to measure adaptive and maladaptive strategies for emotion regulation. The adaptive subscale contains 6 questions and range between 6-42. Higher scores on this subscale mean more adaptive regulation strategies. The maladaptive subscale contains 4 questions and range between 4-28. Higher scores on this subscale mean more maladaptive regulation strategies. |
| 32 weeks |
| Body mass index (BMI) | A statistical index using a person's weight and height to provide an estimate of body fat in people. A BMI of <18.5 indicates medically underweight. A BMI of 18.5 - 25 indicates normal weight. A BMI of >25 indicates overweight. | 32 weeks |
| Client Satisfaction Questionnaire (CSQ-8) | An 8-item self-report questionnaire to measure patient satisfaction with treatment | 32 weeks |
| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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