Clinical trial NCT04701827: Affective Disorders: Eliminate WArning Signs And REstore Functioning: AWARE
Official title: Affective Disorders: Eliminate WArning Signs And REstore Functioning: AWARE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood Disorders
Activities of Daily Living
Quality of Life
Keywords: Bipolar disorder
Mental disorder
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 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

Primary outcomes:
measure: ADL ability
timeFrame: 6 month
Secondary outcomes:
measure: Patient quality of Life
timeFrame: 6 month
measure: Daily functioning
timeFrame: 6 month
Other outcomes:
measure: Cognitive scores using a composite score from baseline to endpoint and physical health
timeFrame: 6 month
Locations:
city: Hillerød
country: Denmark
facility: Psychiatric Centre North Zealand, Copenhagen University Hospital
Study officials:
affiliation: Psychiatric Centre North Zealand, Copenhagen University Hospital
name: Maj Vinberg, Prof, MD, DMSc
role: STUDY_DIRECTOR
References:
citation: Schwarz R, Decker L, Seeberg I, Miskowiak KW, Kessing LV, Vinberg M. Affective disorders: eliminate WArning signs and REstore functioning-AWARE-a randomised controlled multimodule intervention study, presentation of design and intervention. BMJ Open. 2022 May 26;12(5):e058839. doi: 10.1136/bmjopen-2021-058839.