Affective Disorders: Eliminate WArning Signs And REstore Functioning: AWARE

Quality of Life Clinical Trial

— AWARE  

Official title:

Affective Disorders: Eliminate WArning Signs And REstore Functioning: AWARE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04701827
• Other study ID #: H-20029748
• Status: Completed
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: September 30, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Activities of Daily Living
• Mood Disorders
• Quality of Life

Intervention

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).

Locations

Country	Name	City	State
Denmark	Psychiatric Centre North Zealand, Copenhagen University Hospital	Hillerød

Sponsors (1)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognitive scores using a composite score from baseline to endpoint and physical health	SCIP, DART and Trailmaiking	6 month
Primary	ADL ability	Assessment of Motor and Process Skills (AMPS) is a standardized observation-based assessment providing measures of the quality of ADL task performance.	6 month
Secondary	Patient quality of Life	PSS (Cohen's Perceived Stress Scale) and WHOQoL (World Health Organization, Quality of life)	6 month
Secondary	Daily functioning	FAST (Functioning Assessment Short Test) and WHODAS (WHO Disability Assessment Schedule 2.0)	6 month