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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00000079 |
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Date of registration:
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13/03/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Focal psychodynamic psychotherapy, cognitive-behavioural therapy and treatment as usual in outpatients with anorexia nervosa
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Scientific title:
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Focal psychodynamic psychotherapy, cognitive-behavioural therapy and treatment as usual in outpatients with anorexia nervosa - ANTOP (Anorexia Nervosa Treatment of OutPatients) |
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Date of first enrolment:
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14/05/2007 |
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Target sample size:
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237 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00000079 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Gaby
Groß |
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Address:
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Osianderstr. 5
72076
Tübingen
Germany |
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Telephone:
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+49 7071/29-86719 |
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Email:
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gaby.gross@med.uni-tuebingen.de |
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Affiliation:
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Abteilung für Psychosomatische Medizin und Psychotherapie
Innere Medizin VI
Universitätsklinikum Tübingen |
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Name:
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Gaby
Groß |
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Address:
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Osianderstr. 5
72076
Tübingen
Germany |
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Telephone:
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+49 7071/29-86719 |
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Email:
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gaby.gross@med.uni-tuebingen.de |
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Affiliation:
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Abteilung für Psychosomatische Medizin und Psychotherapie
Innere Medizin VI
Universitätsklinikum Tübingen |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Anorexia nervosa (AN) and subsyndromal AN (lacking 1 diagnostic criterion according to Diagnostic and Statistical Manual of Mental Disorders [DSM] IV such as amenorrhea or body image disturbance)
2. Female
3. Aged 18 years or older
4. Body mass index (BMI) between 15.0 and 18.5 kg/m2
5. Signed consent form
Exclusion criteria: 1. Current substance abuse
2. Current neuroleptic medication
3. Current suicidal ideation
4. Psychotic disorder
5. Bipolar disorder
6. Serious unstable medical problems
7. Primary somatic illness
8. Pregnancy or lactation
9. Ongoing psychotherapy
10. Participation in other psychotherapy trials
Age minimum:
18 Years
Age maximum:
None
Gender:
Female
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Health Condition(s) or Problem(s) studied
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F50.0
F50.1
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F50.1
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Anorexia nervosa
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Atypical anorexia nervosa
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F50.0
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Intervention(s)
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Group 1: Focal psychodynamic psychotherapy, 40 individual outpatient session over 10 months
Group 2: Cognitive-behavioural therapy, 40 individual outpatient sessions over 10 months
Group 3: Treatment as usual
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Primary Outcome(s)
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Body mass index (BMI) at the end of treatment (10 months after randomisation; T2). In the statistical analysis the BMI at T2 will be adjusted for the baseline BMI at T0.
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Secondary Outcome(s)
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1. Morgan-Russell criteria
2. General psychopathology
3. Eating disorder psychopathology
4. Depression
5. Quality of life
6. Process measure: therapeutic alliance
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Secondary ID(s)
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01GV0624
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ISRCTN72809357
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Source(s) of Monetary Support
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BMBF: Bundesministerium für Bildung und Forschung
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Ethics review
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Status: Approved
Approval date: 21/02/2007
Contact:
Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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