Affective Disorders: Eliminate WArning Signs And REstore Functioning: AWARE

Not Applicable

Completed

• Conditions: Quality of Life; Activities of Daily Living; Mood Disorders
• Interventions: Combination Product: AWARE intervention

• Registration Number: NCT04701827
• Lead Sponsor: Mental Health Services in the Capital Region, Denmark

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.

Study Timeline

• Study Start: 2020-12-15
• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-08
• Primary Completion: 2023-02-01
• Study Completion: 2023-09-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	AWARE intervention	AWARE intervention

Primary Outcome Measures

Name	Time	Method
ADL ability	6 month	Assessment of Motor and Process Skills (AMPS) is a standardized observation-based assessment providing measures of the quality of ADL task performance.

Secondary Outcome Measures

Name	Time	Method
Patient quality of Life	6 month	PSS (Cohen's Perceived Stress Scale) and WHOQoL (World Health Organization, Quality of life)
Daily functioning	6 month	FAST (Functioning Assessment Short Test) and WHODAS (WHO Disability Assessment Schedule 2.0)

Trial Locations

Locations (1)

Psychiatric Centre North Zealand, Copenhagen University Hospital; 🇩🇰 Hillerød, Denmark