Affective Disorders: Eliminate WArning Signs And REstore Functioning: AWARE (AWARE)

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.

Study Overview

• Status: Completed
• Conditions: Mood Disorders; Quality of Life; Activities of Daily Living
• Intervention / Treatment: Combination product: AWARE intervention

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 Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rasmus EV Schwarz, MD; Phone Number: + 45 21 42 51 75; Email: rasmus.einar.vagn.schwarz@regionh.dk
• Study Contact Backup: Name: Maj Vinberg, Prof, MD, DMSc; Phone Number: + 45 38 64 32 27; Email: maj.vinberg@regionh.dk

Study Locations

• Denmark
  • Hillerød, Denmark, 3400
    • Psychiatric Centre North Zealand, Copenhagen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; AWARE 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).
No Intervention: Control group; Treatment as usual (consisting of the standard out-patient mental health service routines in The Capital Region of Denmark)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive scores using a composite score from baseline to endpoint and physical health	SCIP, DART and Trailmaiking	6 month

Collaborators and Investigators

• Sponsor: Mental Health Services in the Capital Region, Denmark
• Investigators: Study Director: Maj Vinberg, Prof, MD, DMSc, Psychiatric Centre North Zealand, Copenhagen University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Bipolar disorder; Mental disorder
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders
• Other Study ID Numbers: H-20029748

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
• IPD Sharing Time Frame: No current time frame
• IPD Sharing Access Criteria: Reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No