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Affective Disorders: Eliminate WArning Signs And REstore Functioning: AWARE

NCT04701827 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2023-10-23

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Mental Health Services in the Capital Region, Denmark

    lead OTHER

Principal Investigators

  • Maj Vinberg, Prof, MD, DMSc · Psychiatric Centre North Zealand, Copenhagen University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-15
Primary Completion
2023-02-01
Completion
2023-09-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04701827 on ClinicalTrials.gov