Affective Disorders: Eliminate WArning Signs And REstore Functioning: AWARE (AWARE)
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|ClinicalTrials.gov Identifier: NCT04701827|
Recruitment Status : Recruiting
First Posted : January 8, 2021
Last Update Posted : January 8, 2021
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 options, the prognosis for affective disorder remains largely unchanged. Consequently, the field needs new intervention strategies especially targeting the patient groups having impaired functioning. The core idea of the AWARE project is to focus on improving functioning and quality of life in patients with affective disorders every-day life using a comprehensive 360 degrees intervention.
The trial has a randomized, controlled, parallel-group design. Study participants will be 140 outpatients, male or female age 18-60 with a diagnosis of bipolar disorder or recurrent depressive disorder, in a current state of remission, with an objectively rated impaired functioning. Participant will be randomized to six month AWARE intervention or treatment as usual (TAU).
Assessments encompassing Activities of Daily Living (ADL), neuropsychological testing, mood ratings, physical health and questionnaires on subjective cognitive complaints, psychosocial functioning, quality of life are, sleep quality and satisfaction with psychiatric treatment are carried out at baseline and after the end of treatment.
Discussion: It is hypothesised that the AWARE arm in comparison with standard care will improve observed ability to perform Activities of Daily Living (ADL) and improve Quality of Life.
|Condition or disease||Intervention/treatment||Phase|
|Mood Disorders Activities of Daily Living Quality of Life||Combination Product: AWARE intervention||Not Applicable|
Despite different medical and psychological treatment options, the prognosis for affective disorder remains largely unchanged. Consequently, the field needs new intervention strategies especially targeting the patient groups having impaired functioning.
The core idea in the AWARE project is to focus on improving functioning and quality of life in patients with affective disorders every-day life using a comprehensive 360 degrees intervention. The present AWARE intervention represent an integrated treatment avenue to improve functioning in patients with affective disorders.
The aim of the study is, in a pragmatically Randomised Controlled Trial (RCT), to investigate the effect of a 360 degrees intervention based on the ICF Brief Core Set for BD and unipolar disorder targeting functioning.
The participants will upon inclusion, be randomised to participate in either 6 months AWARE treatment or standard care. The control group will receive standard care consisting of the standard out-patient mental health service routines in The Capital Region of Denmark.
The AWARE intervention targets multiple aspects of the described enhancers of functioning based on on the ICF Brief Core Set, including ADL ability as a part of carrying out daily routines.
The study carried out in a randomized design. The investigators who assess the patients are blinded to whether the patient has participated in the active or passive treatment arm, so the results will be valid. In addition, validated standardized survey methods according to all the outcomes is applied.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Affective Disorders: Eliminate WArning Signs And REstore Functioning: AWARE|
|Actual Study Start Date :||December 15, 2020|
|Estimated Primary Completion Date :||April 1, 2023|
|Estimated Study Completion Date :||December 31, 2027|
Experimental: Intervention group
Combination Product: AWARE intervention
Comprehensive 360 degrees intervention. The intervention targets multiple aspects of the described enhancers of functioning based on on the ICF Brief Core Set. 1) ADL ability as a part of carrying out daily routines 2) Mood symptoms, medication and side effects 3) Social, relatives and network 4) Physical health, including BMI, biomarkers and exercise5) Cognition, circadian rhythm measured as sleep quality, and coping (stress reduction).
No Intervention: Control group
Treatment as usual (consisting of the standard out-patient mental health service routines in The Capital Region of Denmark)
- ADL ability [ Time Frame: 6 month ]Assessment of Motor and Process Skills (AMPS) is a standardized observation-based assessment providing measures of the quality of ADL task performance.
- Patient quality of Life [ Time Frame: 6 month ]PSS (Cohen's Perceived Stress Scale) and WHOQoL (World Health Organization, Quality of life)
- Daily functioning [ Time Frame: 6 month ]FAST (Functioning Assessment Short Test) and WHODAS (WHO Disability Assessment Schedule 2.0)
- Cognitive scores using a composite score from baseline to endpoint and physical health [ Time Frame: 6 month ]SCIP, DART and Trailmaiking
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04701827
|Contact: Rasmus EV Schwarz, MD||+ 45 21 42 51 email@example.com|
|Contact: Maj Vinberg, Prof, MD, DMSc||+ 45 38 64 32 firstname.lastname@example.org|
|Psychiatric Centre North Zealand, Copenhagen University Hospital||Recruiting|
|Hillerød, Denmark, 3400|
|Contact: Bettina Boel +45 38 64 30 44 email@example.com|
|Study Director:||Maj Vinberg, Prof, MD, DMSc||Psychiatric Centre North Zealand, Copenhagen University Hospital|