Status:
COMPLETED
Affective Disorders: Eliminate WArning Signs And REstore Functioning: AWARE
Lead Sponsor:
Mental Health Services in the Capital Region, Denmark
Conditions:
Mood Disorders
Activities of Daily Living
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Affective disorders are associated with impaired functioning and quality of life, as well as comorbid somatic disorders and increased mortality. Despite different medical and psychological treatment o...
Detailed Description
Despite different medical and psychological treatment options, the prognosis for affective disorder remains largely unchanged. Consequently, the field needs new intervention strategies especially targ...
Eligibility Criteria
Inclusion
- Diagnosis of bipolar disorder or unipolar disorder by ICD-10 diagnostic criteria (confirmed with a diagnostic interview), in a current state of remission (defined as HDRS-17 and YMRS scores of ≤ 14)
- At inclusion participants must have objectively rated impaired functioning defined as a score ≥ 11 according to the Functioning Assessment Short Test (FAST).
- Participants must be able to participate in 2/3 of the planned visits.
Exclusion
- Severe somatic disorder interfering with daily living
- Ongoing alcohol or substance abuse
- Dementia or inability to cooperate with the study, including inability to speak and read Danish.
- ECT treatment within last 3 month
Key Trial Info
Start Date :
December 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT04701827
Start Date
December 15 2020
End Date
September 30 2023
Last Update
October 23 2023
Active Locations (1)
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1
Psychiatric Centre North Zealand, Copenhagen University Hospital
Hillerød, Denmark, 3400