Schizophrenia, Schizotypal and Delusional DisordersNCT03554655
The Efficacy of Using a Smartphone App to Support Shared Decision Making in People With a Diagnosis of Schizophrenia
A study testing Momentum app in people with Schizophrenia, Schizotypal and Delusional Disorders, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 7 sites in Denmark.
Trial summary
This study investigates the effects of using a smartphone app to support shared decision making (SDM) for people with schizophrenia-spectrum disorders in an outpatient treatment setting. Patients are randomized to specialized early intervention treatment with the Momentum app or without the app. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Schizophrenia, Schizotypal and Delusional Disorders
- What is being tested?
- Momentum app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 7 sitesDenmark
- Study dates
- 7 Jan 2019to 30 Jan 2022
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults of both sexes aged 18+
- A diagnosis of schizophrenia, schizotypal or delusional disorder (ICD-10 codes: F20-F29)
- The patient have received treatment for a maximum of 18 months at the start of the intervention from one of five participating OPUS centre in the Mental Health Services of the Capital Region of Denmark
Who cannot join
- Do not understand or speak Danish
- Unable to give written informed consent to participate in the trial at the described terms
- Are participating in other research studies involving OPUS treatment and an app
- Do not have daily access to a smartphone
- Are suffering of mental retardation or dementia (F. 70-F.79, F.00-F.03)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Denmark7 sites
OPUS Amager
Amager, 2300
OPUS Ballerup
Ballerup Municipality, 2750
OPUS Glostrup
Brøndby, 2605
OPUS Hvidovre
Brøndby, 2605
OPUS Valby
Brøndby, 2605
OPUS Hillerød
Hillerød, 3400
OPUS Østerbro
København Ø, 2100
About this study
Official title: The Momentum Trial: The Efficacy of Using a Smartphone Application to Support Shared Decision Making Through Patient Activation in People With a Diagnosis of Schizophrenia in Outpatient Treatment Settings
This study investigates the effects of using a smartphone app to support shared decision making (SDM) for people with schizophrenia-spectrum disorders in an outpatient treatment setting. Patients are randomized to specialized early intervention treatment with the Momentum app or without the app. The primary objective is to investigate the effect of the app on patient activation 6 months after baseline. Secondary outcomes are positive and negative symptoms, level of functioning; working alliance; self-efficacy; treatment satisfaction; hope; level of SDM; and perceived efficacy in patient-provider interaction. Explorative outcomes are self-perceived usefulness of the Momentum app.
Read the detailed description
Background:
Shared decision making (SDM) may be associated with positive health outcomes for the patient. While practitioners provide a professional expertise with information on the diagnosis, course of the illness, treatment options and potential side effects, patients are experts on their own needs, treatment preferences and goals. In mental healthcare, SDM have been assessed as a promising treatment intervention to promote patient involvement and clinical guidelines advocate the use of SDM as a patient-centered mental health care and a mean to increase patient empowerment. Although SDM today seems to be a preferred model for clinical decision-making for both patients and providers in mental health, patients indicate that they are not involved as much as they want to be in their treatment. Studies on SDM interventions for people with mental health issues are somewhat sparse and due to a small number of RCT studies, the evidence on SDM in mental health has been concluded as encouraging but inconclusive.
Based on recent research, a digital healthcare solution which links patients and providers together could assist in providing support and potentially promote SDM. Findings from existing randomized controlled trials suggest that electronic aids to support SDM are a promising mean to engage patients in their mental health treatment. Recent systematic reviews do, however, highlight a need for more evidence-based research on the efficacy and effectiveness of mental health apps.
Intervention:
Momentum is a smartphone app, developed to support people with schizophrenia-spectrum disorders to prepare for treatment consultations while becoming more involved in treatment decisions. The app was developed in the period of 2013-2014 to support SDM in the Mental Health Services of the Capital Region of Denmark in a process of co-creation. Afterwards, the app was tested by 116 mental health professionals and 78 patients from three different mental health treatment sites: community of mental health, inpatient- and outpatient treatment sites. The app has since then been optimized based on the feedback received from the study participants.
Aim:
The purpose of this trial is to investigate the effects of the smartphone app Momentum for people with a diagnosis of schizophrenia, schizotypal or delusional disorders within outpatient treatment settings in a randomized design. Our main hypothesis is that patients using the Momentum app in combination with receiving specialized early intervention treatment (i.e. treatment as usual (TAU)), compared to patients only receiving TAU, will show greater improvements in patient activation, 6 months after baseline (primary outcome). Our secondary hypothesis is that patients using the Momentum app in combination with receiving TAU, compared to patients only receiving TAU, will show greater improvements regarding self-perceived level of SDM; self-efficacy; the therapeutic alliance; hope and optimism; satisfaction with treatment; patient's confidence in communicating preferences and concerns to their provider; severity of symptoms and; level of functioning (secondary outcomes). Lastly, the investigators hypothesize that there is a correlation between the effects of using the Momentum app and self-reported usefulness of the Momentum app and/or app usage (user sessions per day, screen views per day, screens per session, session duration and session instances, user retention) (explorative outcomes).
- Being tested
- Momentum app
- Keywords
- Shared decision making, Patient activation, Schizophrenia, First-episode psychosis, mHealth, Randomized clinical trial
- Medical subject headings
- Schizophrenia, Schizophrenia, Paranoid, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Momentum appDevice
The Momentum system consists of a smartphone app (for the patient) and a web portal (for the provider). Information entered in the app by the patient will automatically be transferred to the web portal for the provider to see. While one goal of the system is to support SDM, the Momentum app is not a classic decision aid focusing on finding a choice to a one-off treatment decision. Instead, the Momentum app is an aid to support some of the underlying elements behind SDM such as collaboration with one's provider, awareness and eliciting of one's needs, preferences and values.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Momentum app | Experimental | Intervention Group will receive treatment as usual together with the Momentum app. Receives: Device: Momentum app |
| Control | No intervention | Control Group will receive treatment as usual without the Momentum app. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient activation measured with the Consumer Health Activation Index - Mental Health (CHAI-MH)
Completed by patients. The 10-item instrument was developed based on 5 key domains: knowledge, self-efficacy, motivation and beliefs, actions, and internal locus of control. The questionnaire is rated on a 6-point Likert scale ranging from "Strongly disagree" to "Strongly agree". Afterwards, the scores are transformed into a theoretical value from 0 to 100, with higher scores signifying a stronger involvement in the treatment and confidence in the ability to take care of one's own health and health treatment.
Measured: baseline, 3 months and end of intervention (6 months)
Secondary outcomes (15)
Change in self-efficacy measured with the General Self-Efficacy scale (GSE)
Completed by patients. The questions consists of 10 items rated on a 4-point Likert scale ranging from "not at all true" (1) to "exactly true" (4) with higher scores indicating higher self-efficacy.
Measured: baseline, 3 months and end of intervention (6 months)
Change in preparedness for decision making measured with the scale Preparation for Decision Making (PrepDM)
Completed by patients. The 10-item instrument measures the patient's perception of how useful a decision aid or other decision support intervention is. The questionnaire is rated on a 5-point Likert scale from "Not at all" (1) to "A great deal" (5) with higher scores indicating a higher level of preparedness to communicate with one's care provider regarding health decisions.
Measured: baseline and 6 months
Change in hope measured with the Adult State Hope Scale (ASH)
Completed by patients. The 6-item instrument is rated on a Likert-scale from 1-8, with higher scores indicating higher levels of hope.
Measured: baseline, 3 months and end of intervention (6 months)
Change in the efficacy of interactions measured with the scale Perceived Efficacy in Patient-Provider Interactions (PEPPI)
Completed by patients. The 5-item instrument measures the assessment of patient's confidence in communicating with their physician. The questionnaire is rated on a 10-point Likert scale, with higher scores indicating higher perceived efficacy in the interactions
Measured: baseline, 3 months and end of intervention (6 months)
Change in treatment satisfaction measured with the Client Satisfaction Questionnaire (CSQ)
Completed by patients. The 8-item instrument measures a patient's satisfaction with treatment. Each item is scored on a 4-point Likert scale, with higher scores indicating higher satisfaction.
Measured: baseline and 6 months
App Rating Questionnaire (ARQ) and usage of the Momentum app will be combined to report patients self-perceived usefulness of the app
Completed by patients in the intervention Group. ARQ is used to measure the users experience with the app. Higher scores indicating higher perceived usefulness of the app.
Measured: 6 months
Change in treatment alliance measured with the Working Alliance Inventory - short version (WAI-S). Patient version.
Completed by patients. The questionnaire consists of 12 items rated on a 7-point Likert scale, with higher scores indicating better self-perceived working alliance with ones provider.
Measured: baseline and 6 months
Change in treatment alliance measured with the Working Alliance Inventory - short version (WAI-S). Clinician version.
Completed by providers.The questionnaire consists of 12 items rated on a 7-point Likert scale, with higher scores indicating better self-perceived working alliance with ones patient.
Measured: baseline and 6 months
Clinical Decision Making Style - Service user (CDMS-P)
Completed by patients. The 21-item measures preferences in clinical decision making. The questionnaire is rated on a 5-point Likert scale with higher scores indicating a higher desire to be an active participant in decision making and to be provided with information.
Measured: baseline
Clinical Decision Making Style - Staff questionnaire (CDMS-S).
Completed by providers. The questionnaire is rated on a 5-point Likert scale with higher scores indicating a higher desire by the clinician for active service user participation in decision making and to provide information to the service user.
Measured: baseline
Service Engagement Scale - Collaboration sub-domain only (SES)
Completed by providers. The scale is a 14-item measurement for the provider to rate their patient's engagement level on the subscale Collaboration. Each item is scored on a 4 point Likert scale, with higher scores indicating poorer engagement.
Measured: baseline and 6 months
Change in positive symptoms measured by the Scale for the Assessment of Positive Symptoms (SAPS)
Each dimension within SAPS is scored between 0-5 with higher scores indicating higher symptom severity
Measured: baseline and 6 months
Change in negative symptoms measured by the Scale for the Assessment of Negative Symptoms (SANS)
Each dimension within SANS is scored between 0-5 with higher scores indicating higher symptom severity
Measured: baseline and 6 months
Change in level of functioning measured with the Global Assessment of Functioning (GAF)
GAF assesses a person's psychosocial functioning (scores 1-100), with higher scores indicating a higher functioning level.
Measured: baseline and 6 months
Change in level of functioning measured with the Personal and Social Performance Scale (PSP)
PSP assesses a person's functioning level within four domains; socially useful activities; Personal and social relationships; Self-care; Disturbing and aggressive behaviors. PSP is scored 1-100, with higher scores indicating a higher functioning level.
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start7 Jan 2019
- Primary completion30 Sep 2021
- Study completion30 Jan 2022
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 Schizophrenia, Schizotypal and Delusional 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-arm, observer-blinded, parallel group randomised controlled superiority trial will be used for this intervention. Participants will be placed in one of two groups: Intervention group: treatment as usual (TAU) together with the Momentum app or (2) Control group: TAU without the Momentum app.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark, Odense Patient Data Explorative Network
- Responsible party
- Sponsor
- Investigators
- Lisa Korsbek, ph.d., Principal investigator, Mental Health Services in the Region of Southern Denmark, Odense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554655
- Sponsor's protocol ID
- 115441
- Other IDs
- H-17025550
- Status last verified
- Apr 2022
- First submitted
- 30 Apr 2018
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vitger T, Hjorthoj C, Austin SF, Petersen L, Tonder ES, Nordentoft M, Korsbek L. A Smartphone App to Promote Patient Activation and Support Shared Decision-making in People With a Diagnosis of Schizophrenia in Outpatient Treatment Settings (Momentum Trial): Randomized Controlled Assessor-Blinded Trial. J Med Internet Res. 2022 Oct 26;24(10):e40292. doi: 10.2196/40292.
PubMed 36287604Vitger T, Austin SF, Petersen L, Tonder ES, Nordentoft M, Korsbek L. The Momentum trial: the efficacy of using a smartphone application to promote patient activation and support shared decision making in people with a diagnosis of schizophrenia in outpatient treatment settings: a randomized controlled single-blind trial. BMC Psychiatry. 2019 Jun 17;19(1):185. doi: 10.1186/s12888-019-2143-2.
PubMed 31208376
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Momentum Trial: The Efficacy of Using a Smartphone Application to Support Shared Decision Making Through Patient Activation in People With a Diagnosis of Schizophrenia in Outpatient Treatment Settings
- ClinicalTrials.gov ID
- NCT03554655
- Acronym / sponsor ID
- 115441
- Keywords
- Shared decision making, Patient activation, Schizophrenia, First-episode psychosis, mHealth, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark, Odense Patient Data Explorative Network
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 13 Jun 2018 (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.
This study investigates the effects of using a smartphone app to support shared decision making (SDM) for people with schizophrenia-spectrum disorders in an outpatient treatment setting. Patients are randomized to specialized early intervention treatment with the Momentum app or without the app. The primary objective is to investigate the effect of the app on patient activation 6 months after baseline. Secondary outcomes are positive and negative symptoms, level of functioning; working alliance; self-efficacy; treatment satisfaction; hope; level of SDM; and perceived efficacy in patient-provider interaction. Explorative outcomes are self-perceived usefulness of the Momentum app.
Detailed description
Background:
Shared decision making (SDM) may be associated with positive health outcomes for the patient. While practitioners provide a professional expertise with information on the diagnosis, course of the illness, treatment options and potential side effects, patients are experts on their own needs, treatment preferences and goals. In mental healthcare, SDM have been assessed as a promising treatment intervention to promote patient involvement and clinical guidelines advocate the use of SDM as a patient-centered mental health care and a mean to increase patient empowerment. Although SDM today seems to be a preferred model for clinical decision-making for both patients and providers in mental health, patients indicate that they are not involved as much as they want to be in their treatment. Studies on SDM interventions for people with mental health issues are somewhat sparse and due to a small number of RCT studies, the evidence on SDM in mental health has been concluded as encouraging but inconclusive.
Based on recent research, a digital healthcare solution which links patients and providers together could assist in providing support and potentially promote SDM. Findings from existing randomized controlled trials suggest that electronic aids to support SDM are a promising mean to engage patients in their mental health treatment. Recent systematic reviews do, however, highlight a need for more evidence-based research on the efficacy and effectiveness of mental health apps.
Intervention:
Momentum is a smartphone app, developed to support people with schizophrenia-spectrum disorders to prepare for treatment consultations while becoming more involved in treatment decisions. The app was developed in the period of 2013-2014 to support SDM in the Mental Health Services of the Capital Region of Denmark in a process of co-creation. Afterwards, the app was tested by 116 mental health professionals and 78 patients from three different mental health treatment sites: community of mental health, inpatient- and outpatient treatment sites. The app has since then been optimized based on the feedback received from the study participants.
Aim:
The purpose of this trial is to investigate the effects of the smartphone app Momentum for people with a diagnosis of schizophrenia, schizotypal or delusional disorders within outpatient treatment settings in a randomized design. Our main hypothesis is that patients using the Momentum app in combination with receiving specialized early intervention treatment (i.e. treatment as usual (TAU)), compared to patients only receiving TAU, will show greater improvements in patient activation, 6 months after baseline (primary outcome). Our secondary hypothesis is that patients using the Momentum app in combination with receiving TAU, compared to patients only receiving TAU, will show greater improvements regarding self-perceived level of SDM; self-efficacy; the therapeutic alliance; hope and optimism; satisfaction with treatment; patient's confidence in communicating preferences and concerns to their provider; severity of symptoms and; level of functioning (secondary outcomes). Lastly, the investigators hypothesize that there is a correlation between the effects of using the Momentum app and self-reported usefulness of the Momentum app and/or app usage (user sessions per day, screen views per day, screens per session, session duration and session instances, user retention) (explorative outcomes).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A two-arm, observer-blinded, parallel group randomised controlled superiority trial will be used for this intervention. Participants will be placed in one of two groups: Intervention group: treatment as usual (TAU) together with the Momentum app or (2) Control group: TAU without the Momentum app.
| Arm | Type | Receives |
|---|---|---|
| Intervention: Momentum app | Experimental | Device: Momentum appIntervention Group will receive treatment as usual together with the Momentum app. |
| Control | No intervention | –Control Group will receive treatment as usual without the Momentum app. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults of both sexes aged 18+
- A diagnosis of schizophrenia, schizotypal or delusional disorder (ICD-10 codes: F20-F29)
- The patient have received treatment for a maximum of 18 months at the start of the intervention from one of five participating OPUS centre in the Mental Health Services of the Capital Region of Denmark
Key exclusion criteria (5 listed)
- Do not understand or speak Danish
- Unable to give written informed consent to participate in the trial at the described terms
- Are participating in other research studies involving OPUS treatment and an app
- Do not have daily access to a smartphone
- Are suffering of mental retardation or dementia (F. 70-F.79, F.00-F.03)
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 |
|---|---|---|
| Momentum appThe Momentum system consists of a smartphone app (for the patient) and a web portal (for the provider). Information entered in the app by the patient will automatically be transferred to the web portal for the provider to see. While one goal of the system is to support SDM, the Momentum app is not a classic decision aid focusing on finding a choice to a one-off treatment decision. Instead, the Momentum app is an aid to support some of the underlying elements behind SDM such as collaboration with one's provider, awareness and eliciting of one's needs, preferences and values. | Device | Intervention: Momentum app |
Primary outcome
Change in patient activation measured with the Consumer Health Activation Index - Mental Health (CHAI-MH)
Time frame: baseline, 3 months and end of intervention (6 months)
Completed by patients. The 10-item instrument was developed based on 5 key domains: knowledge, self-efficacy, motivation and beliefs, actions, and internal locus of control. The questionnaire is rated on a 6-point Likert scale ranging from "Strongly disagree" to "Strongly agree". Afterwards, the scores are transformed into a theoretical value from 0 to 100, with higher scores signifying a stronger involvement in the treatment and confidence in the ability to take care of one's own health and health treatment.
15 secondary outcomes
Change in self-efficacy measured with the General Self-Efficacy scale (GSE)
Time frame: baseline, 3 months and end of intervention (6 months)
Change in preparedness for decision making measured with the scale Preparation for Decision Making (PrepDM)
Time frame: baseline and 6 months
Change in hope measured with the Adult State Hope Scale (ASH)
Time frame: baseline, 3 months and end of intervention (6 months)
Change in the efficacy of interactions measured with the scale Perceived Efficacy in Patient-Provider Interactions (PEPPI)
Time frame: baseline, 3 months and end of intervention (6 months)
Change in treatment satisfaction measured with the Client Satisfaction Questionnaire (CSQ)
Time frame: baseline and 6 months
App Rating Questionnaire (ARQ) and usage of the Momentum app will be combined to report patients self-perceived usefulness of the app
Time frame: 6 months
Change in treatment alliance measured with the Working Alliance Inventory - short version (WAI-S). Patient version.
Time frame: baseline and 6 months
Change in treatment alliance measured with the Working Alliance Inventory - short version (WAI-S). Clinician version.
Time frame: baseline and 6 months
Clinical Decision Making Style - Service user (CDMS-P)
Time frame: baseline
Clinical Decision Making Style - Staff questionnaire (CDMS-S).
Time frame: baseline
Service Engagement Scale - Collaboration sub-domain only (SES)
Time frame: baseline and 6 months
Change in positive symptoms measured by the Scale for the Assessment of Positive Symptoms (SAPS)
Time frame: baseline and 6 months
Change in negative symptoms measured by the Scale for the Assessment of Negative Symptoms (SANS)
Time frame: baseline and 6 months
Change in level of functioning measured with the Global Assessment of Functioning (GAF)
Time frame: baseline and 6 months
Change in level of functioning measured with the Personal and Social Performance Scale (PSP)
Time frame: baseline and 6 months
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 8 Apr 2022.
- Derived from this study: PubMed 36287604Vitger T, Hjorthoj C, Austin SF, Petersen L, Tonder ES, Nordentoft M, Korsbek L. A Smartphone App to Promote Patient Activation and Support Shared Decision-making in People With a Diagnosis of Schizophrenia in Outpatient Treatment Settings (Momentum Trial): Randomized Controlled Assessor-Blinded Trial. J Med Internet Res. 2022 Oct 26;24(10):e40292. doi: 10.2196/40292.
- Derived from this study: PubMed 31208376Vitger T, Austin SF, Petersen L, Tonder ES, Nordentoft M, Korsbek L. The Momentum trial: the efficacy of using a smartphone application to promote patient activation and support shared decision making in people with a diagnosis of schizophrenia in outpatient treatment settings: a randomized controlled single-blind trial. BMC Psychiatry. 2019 Jun 17;19(1):185. doi: 10.1186/s12888-019-2143-2.
- Individual participant dataSharing planned: No
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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.
Lisa Korsbek, ph.d. principal investigator
Mental Health Services in the Region of Southern Denmark, Odense
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Momentum app in people with Schizophrenia, Schizotypal and Delusional Disorders, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 7 sites 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 5 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 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Change in patient activation measured with the Consumer Health Activation Index - Mental Health (CHAI-MH) (time frame: baseline, 3 months and end of intervention (6 months)). 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 NCT03554655, 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 8 Apr 2022.