Affective Disorders: Eliminate WArning Signs And REstore Functioning: AWARE
Condition: Mood Disorders; Activities of Daily Living; Quality of Life
MeSH terms: Mood Disorders
Study type: Interventional

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 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 18-65 with a diagnosis of bipolar disorder or unipolar
      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.
    

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 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.
    

Intervention name(s): AWARE intervention
Intervention type(s): Combination Product
Intervention description(s): 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar disorder; Mental disorder