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

• ClinicalTrials.gov Identifier: NCT04701827
• Recruitment Status: Recruiting
• First Posted: January 8, 2021
• Last Update Posted: March 9, 2022
• Sponsor: Mental Health Services in the Capital Region, Denmark
• Information provided by (Responsible Party): Mental Health Services in the Capital Region, Denmark

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Mood Disorders; Activities of Daily Living; Quality of Life	Combination Product: AWARE intervention	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Affective Disorders: Eliminate WArning Signs And REstore Functioning: AWARE
• Actual Study Start Date: December 15, 2020
• Estimated Primary Completion Date: April 1, 2023
• Estimated Study Completion Date: December 31, 2027

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. ADL ability [ Time Frame: 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 :

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

Other Outcome Measures:

1. Cognitive scores using a composite score from baseline to endpoint and physical health [ Time Frame: 6 month ]
   SCIP, DART and Trailmaiking

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Rasmus EV Schwarz, MD; + 45 21 42 51 75; rasmus.einar.vagn.schwarz@regionh.dk

Contact: Maj Vinberg, Prof, MD, DMSc; + 45 38 64 32 27; maj.vinberg@regionh.dk

Locations

Denmark

Psychiatric Centre North Zealand, Copenhagen University Hospital; Recruiting

Hillerød, Denmark, 3400

Contact: Bettina Boel +45 38 64 30 44 bettina.boel@regionh.dk

Sponsors and Collaborators

Mental Health Services in the Capital Region, Denmark

Investigators

• Study Director: Maj Vinberg, Prof, MD, DMSc; Psychiatric Centre North Zealand, Copenhagen University Hospital

More Information

• Responsible Party: Mental Health Services in the Capital Region, Denmark
• ClinicalTrials.gov Identifier: NCT04701827
• Other Study ID Numbers: H-20029748
• First Posted: January 8, 2021
• Last Update Posted: March 9, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
• Time Frame: No current time frame
• Access Criteria: Reasonable request

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mental Health Services in the Capital Region, Denmark:

Bipolar disorder; Mental disorder

Additional relevant MeSH terms:

Disease; Mood Disorders; Pathologic Processes; Mental Disorders