Mood DisordersAWARENCT04701827
Affective Disorders: Eliminate WArning Signs And REstore Functioning: AWARE
A study testing AWARE intervention in people with Mood Disorders and Activities of Daily Living, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mood Disorders, Activities of Daily Living, Quality of Life
- What is being tested?
- AWARE intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Dec 2020to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Psychiatric Centre North Zealand, Copenhagen University Hospital
Hillerød, 3400
About this study
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).
Read more
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.
Read the 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.
- Conditions
- Mood Disorders, Activities of Daily Living, Quality of Life
- Being tested
- AWARE intervention
- Keywords
- Bipolar disorder, Mental disorder
- Medical subject headings
- Mood Disorders, Bipolar Disorder, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AWARE interventionCombination 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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | AWARE intervention Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADL ability
Assessment of Motor and Process Skills (AMPS) is a standardized observation-based assessment providing measures of the quality of ADL task performance.
Measured: 6 month
Secondary outcomes (2)
Patient quality of Life
PSS (Cohen's Perceived Stress Scale) and WHOQoL (World Health Organization, Quality of life)
Measured: 6 month
Daily functioning
FAST (Functioning Assessment Short Test) and WHODAS (WHO Disability Assessment Schedule 2.0)
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start15 Dec 2020
- Primary completion1 Feb 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maj Vinberg, Prof, MD, DMSc, Study director, Psychiatric Centre North Zealand, Copenhagen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701827
- Sponsor's protocol ID
- H-20029748
- Acronym
- AWARE
- Status last verified
- Oct 2023
- First submitted
- 6 Jan 2021
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Publications
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;54(14):3985-3994. doi: 10.1017/S0033291724002526. Epub 2024 Oct 31.
PubMed 39479758Schwarz 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.
PubMed 35618335
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affective Disorders: Eliminate WArning Signs And REstore Functioning: AWARE
- ClinicalTrials.gov ID
- NCT04701827
- Acronym / sponsor ID
- AWARE / H-20029748
- Conditions
- Mood Disorders, Activities of Daily Living, Quality of Life
- Keywords
- Bipolar disorder, Mental disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Combination Product: AWARE interventionAWARE intervention |
| Control group | No intervention | –Treatment as usual (consisting of the standard out-patient mental health service routines in The Capital Region of Denmark) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AWARE interventionComprehensive 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). | Combination product | Intervention group |
Primary outcome
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.
2 secondary outcomes
Patient quality of Life
Time frame: 6 month
Daily functioning
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 39479758Schwarz 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;54(14):3985-3994. doi: 10.1017/S0033291724002526. Epub 2024 Oct 31.
- Derived from this study: PubMed 35618335Schwarz 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.
- Individual participant dataSharing planned: Yes. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maj Vinberg, Prof, MD, DMSc study director
Psychiatric Centre North Zealand, Copenhagen University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AWARE intervention in people with Mood Disorders and Activities of Daily Living, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADL ability (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04701827, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.