Affective Disorders: Eliminate WArning Signs And REstore Functioning: AWARE

NCT04701827 | Completed DMC

• 1 other identifier: H-20029748
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Mood Disorders; Activities of Daily Living; Quality of Life

Keywords

Bipolar disorder; Mental disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient quality of Life

  6 month

• Daily functioning

  6 month

Other Outcomes (1)

• Cognitive scores using a composite score from baseline to endpoint and physical health

  6 month

Study Arms (2)

Intervention group

EXPERIMENTAL

AWARE intervention

Combination Product: AWARE intervention

Control group

NO INTERVENTION

Treatment as usual (consisting of the standard out-patient mental health service routines in The Capital Region of Denmark)

Interventions

AWARE intervention COMBINATION_PRODUCT

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).

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Participants must be able to participate in 2/3 of the planned visits.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead

Study Sites (1)

Psychiatric Centre North Zealand, Copenhagen University Hospital

Hillerød, 3400, Denmark

Location

Related Publications (2)

• Schwarz R, Miskowiak KW, Christensen MS, Kessing LV, Vinberg M. Affective disorders: eliminate WArning signs And REstore functioning: AWARE. Results from a randomized controlled multimodular intervention study targeting functioning in patients with affective disorders. Psychol Med. 2024 Oct 31;54(14):1-10. doi: 10.1017/S0033291724002526. Online ahead of print.

  PMID: 39479758 DERIVED

• 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.

  PMID: 35618335 DERIVED

MeSH Terms

Conditions

Mood Disorders; Bipolar Disorder; Mental Disorders

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders

Study Officials

• Maj Vinberg, Prof, MD, DMSc

  Psychiatric Centre North Zealand, Copenhagen University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 8, 2021
• Study Start: December 15, 2020
• Primary Completion: February 1, 2023
• Study Completion: September 30, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: No current time frame
• Access Criteria: Reasonable request

Locations

DK (1)