Affective Disorders: Eliminate WArning Signs And REstore Functioning: AWARE

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    140
  • sponsor
    Mental Health Services in the Capital Region, Denmark
Updated on 28 January 2021

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 18-60 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.

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.

Details
Condition mood disorder, Affective Disorders, Mood Disorders, Mood Disorders (Pediatric), ADL, Quality of life, Mood Disorders (Pediatric), Affective Disorders, Mood Disorders, quality-of-life, affective disorder
Treatment AWARE intervention
Clinical Study IdentifierNCT04701827
SponsorMental Health Services in the Capital Region, Denmark
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of bipolar disorder or recurrent depressive 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 7)
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 Criteria

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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