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Completed

NCT Number: NCT04701827

Affective Disorders: Eliminate WArning Signs And REstore Functioning: 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.

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Key information

Conditions

Mood Disorders Activities of Daily Living Bipolar Disorder Bipolar and Related Disorders Mental Disorders Quality of Life

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychiatric Centre North Zealand, Copenhagen University Hospital

Hillerød, 3400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  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 outcomes

  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 outcomes

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

    Time frame: 6 month

    SCIP, DART and Trailmaiking

Sponsors and collaborators

Lead sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Other

Registry information

Acronym: AWARE

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 8, 2021
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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