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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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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01158430 |
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Date of registration:
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16/02/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Acceptance and Commitment Group Therapy (ACT) for Patients With Health Anxiety
ACT |
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Scientific title:
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Treatment of Patients With Health Anxiety. A Randomized Controlled Trial of Acceptance and Commitment Therapy (ACT) Group Treatment Compared to a Waiting List |
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Date of first enrolment:
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March 2010 |
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Target sample size:
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126 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01158430 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Per Fink, DMSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Whiteley-7 score on 21,4 or more (scale 0-100 score points).
2. Severe health anxiety (diagnosed by SCAN interview).
3. Age 20-60 years
4. Patients of Scandinavian origin who understand, read, write and speak Danish.
5. No lifetime-diagnosis of psychoses, bipolar affective disorder or depression with
psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3)
6. In case of a co morbid functional or other psychiatric disorder health anxiety must
be the dominating problem.
Exclusion criteria:
1. Another severe psychiatric disorder or if the patient is suicidal.
2. Abuse of narcotics or alcohol and (non-prescribed) medicine.
3. Pregnancy.
4. No informed consent.
Age minimum:
20 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Somatization Disorder
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Hypochondriasis
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Intervention(s)
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Behavioral: ACT group therapy
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Primary Outcome(s)
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Health anxiety measured by the Whiteley-7 index
[Time Frame: 9 months (2nd follow-up)]
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Secondary Outcome(s)
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Social level of functioning measured with an alcohol dependency questionnaire (CAGE)
[Time Frame: 9 months (2nd follow-up)]
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Physical symptoms measured with somatisation subscales from Symptom Check List, 90 items (SCL 90)
[Time Frame: 9 months (2nd follow-up)]
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ACT process measures measured with Acceptance and Action Questionnaire - II (AAQ II)
[Time Frame: 9 months (2nd follow-up)]
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Health care use (National Patient Register & National Health Service Register (general practitioner (GP) contacts/consultations, specialists, physiotherapists, dentists, GPs' emergency service), The Danish Medicine Agency (medicine consumption)).
[Time Frame: 9 months (2nd follow-up)]
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Sick days (the DREAM database - the register-based evaluation of the extent of marginalization)
[Time Frame: 9 months (2nd follow-up)]
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Illness perception measured with Illness Perception Questionnaire (IPQ)
[Time Frame: 9 months (2nd follow-up)]
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Social level of functioning, emotional disorders measured with relevant sub-scales from Symptom Check List, 90 items (SCL 90)
[Time Frame: 9 months (2nd follow-up)]
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Social level of functioning measured with Short Form health status questionnaire from the medical outcome status (SF-36)
[Time Frame: 9 months (2nd follow-up)]
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ACT process measures measured with Five Facet Mindfulness Questionnaire (FFMQ)
[Time Frame: 9 months (2nd follow-up)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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