Mild DepressionNCT03659630
MyCompass in a Swedish Context - an Automated Self-help Intervention Targeting Mental Health Problems
A study testing MyCompass and Comparison group in people with Mild Depression and Anxiety State, run by Karolinska Institutet.
Trial summary
The study present findings from the implementation of myCompass, a fully automated self-help intervention of Australian origin for mild to moderate anxiety and depression, in a Swedish context. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Depression, Anxiety State, Sleep Disturbance
- What is being tested?
- MyCompass and Comparison group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 837 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Jan 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Swedish resident
- Valid e-mail address
- 18 years old or older
- PHQ-9 score of 5-20
- GAD-7 score of 5-15
Who cannot join
- suicidal thoughts
About this study
Official title: MyCompass in a Swedish Context - Lessons Learned From the Transfer of an Automated Self-help Intervention Targeting Mental Health Problems
The study present findings from the implementation of myCompass, a fully automated self-help intervention of Australian origin for mild to moderate anxiety and depression, in a Swedish context. The study also investigates the usage of a specially designed research platform aimed at handling informed consent and online surveys.
- Being tested
- MyCompass, Comparison group
- Medical subject headings
- Anxiety Disorders, Parasomnias, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyCompassBehavioural
Self-help tools to change behaviours in various different domains including sleep deprivation, anxiety and depression.
Comparison groupBehavioural
An email containing a brief text on general tips regarding mental health was sent out once a week.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group receives the MyCompass intervention, an automated self-help intervention for mild to moderate mental ill-health. Receives: Behavioral: MyCompass |
| Comparison group | Placebo comparator | The control group receives a brief email each week, describing the most common mental health issues. Receives: Behavioral: Comparison group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
Self-report measure on depressive symptoms. Nine items, each of which is scored 0 to 3, providing a 0 to 27 severity score, where a higher score indicates more severe depression. Scores of 5, 10, 15, and 20 are taken as the cut-off points for mild, moderate, moderate to severe and severe depression, respectively. For the purpose of this study, participants with a score between 5-20 were included.
Measured: 2 weeks
Generalised Anxiety Disorder 7-item scale (GAD-7)
Self-report measure on anxiety symptoms. Seven items with score 0-21, a higher score indicating more severe anxiety. Cutoffs: Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. For the purpose of this study, participants with a score between 5-15 were included.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study startDec 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild DepressionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 837 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clara Hellner Gumpert, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659630
- Sponsor's protocol ID
- 2015/1268-31/2 + 2016/88
- Status last verified
- Sep 2021
- First submitted
- 3 Sep 2018
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nilsson A, Sorman K, Klingvall J, Ovelius E, Lundberg J, Hellner C. MyCompass in a Swedish context - lessons learned from the transfer of a self-guided intervention targeting mental health problems. BMC Psychiatry. 2019 Jan 31;19(1):51. doi: 10.1186/s12888-019-2039-1.
PubMed 30704424
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyCompass in a Swedish Context - Lessons Learned From the Transfer of an Automated Self-help Intervention Targeting Mental Health Problems
- ClinicalTrials.gov ID
- NCT03659630
- Acronym / sponsor ID
- 2015/1268-31/2 + 2016/88
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 837 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 6 Sep 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.
The study present findings from the implementation of myCompass, a fully automated self-help intervention of Australian origin for mild to moderate anxiety and depression, in a Swedish context. The study also investigates the usage of a specially designed research platform aimed at handling informed consent and online surveys.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: MyCompassThe intervention group receives the MyCompass intervention, an automated self-help intervention for mild to moderate mental ill-health. |
| Comparison group | Placebo comparator | Behavioral: Comparison groupThe control group receives a brief email each week, describing the most common mental health issues. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Swedish resident
- Valid e-mail address
- 18 years old or older
- PHQ-9 score of 5-20
- GAD-7 score of 5-15
Key exclusion criteria (1 listed)
- suicidal thoughts
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 |
|---|---|---|
| MyCompassSelf-help tools to change behaviours in various different domains including sleep deprivation, anxiety and depression. | Behavioural | Intervention group |
| Comparison groupAn email containing a brief text on general tips regarding mental health was sent out once a week. | Behavioural | Comparison group |
Primary outcome
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 2 weeks
Self-report measure on depressive symptoms. Nine items, each of which is scored 0 to 3, providing a 0 to 27 severity score, where a higher score indicates more severe depression. Scores of 5, 10, 15, and 20 are taken as the cut-off points for mild, moderate, moderate to severe and severe depression, respectively. For the purpose of this study, participants with a score between 5-20 were included.
Generalised Anxiety Disorder 7-item scale (GAD-7)
Time frame: 2 weeks
Self-report measure on anxiety symptoms. Seven items with score 0-21, a higher score indicating more severe anxiety. Cutoffs: Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. For the purpose of this study, participants with a score between 5-15 were included.
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 9 Sep 2021.
- Derived from this study: PubMed 30704424Nilsson A, Sorman K, Klingvall J, Ovelius E, Lundberg J, Hellner C. MyCompass in a Swedish context - lessons learned from the transfer of a self-guided intervention targeting mental health problems. BMC Psychiatry. 2019 Jan 31;19(1):51. doi: 10.1186/s12888-019-2039-1.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MyCompass and Comparison group in people with Mild Depression and Anxiety State, run by Karolinska Institutet.
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 5 inclusion and 1 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 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Patient Health Questionnaire-9 (PHQ-9) (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 NCT03659630, which also lists 1 linked publication.
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 9 Sep 2021.