Back to resultsMyCompass in a Swedish Context - an Automated Self-help Intervention Targeting Mental Health Problems
Primary Purpose
Mild Depression, Anxiety State, Sleep Disturbance
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MyCompass
Comparison group
Sponsored by
About this trial
This is an interventional treatment trial for Mild Depression
Eligibility Criteria
Inclusion Criteria:
- Swedish resident
- Valid e-mail address
- 18 years old or older
- PHQ-9 score of 5-20
- GAD-7 score of 5-15
Exclusion Criteria:
- suicidal thoughts
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention group
Comparison group
Arm Description
The intervention group receives the MyCompass intervention, an automated self-help intervention for mild to moderate mental ill-health.
The control group receives a brief email each week, describing the most common mental health issues.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03659630
First Posted
September 3, 2018
Last Updated
September 1, 2021
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT03659630
Brief Title
MyCompass in a Swedish Context - an Automated Self-help Intervention Targeting Mental Health Problems
Official Title
MyCompass in a Swedish Context - Lessons Learned From the Transfer of an Automated Self-help Intervention Targeting Mental Health Problems
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. The study also investigates the usage of a specially designed research platform aimed at handling informed consent and online surveys.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Depression, Anxiety State, Sleep Disturbance, Stress, Psychological
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
837 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The intervention group receives the MyCompass intervention, an automated self-help intervention for mild to moderate mental ill-health.
Arm Title
Comparison group
Arm Type
Placebo Comparator
Arm Description
The control group receives a brief email each week, describing the most common mental health issues.
Intervention Type
Behavioral
Intervention Name(s)
MyCompass
Intervention Description
Self-help tools to change behaviours in various different domains including sleep deprivation, anxiety and depression.
Intervention Type
Behavioral
Intervention Name(s)
Comparison group
Intervention Description
An email containing a brief text on general tips regarding mental health was sent out once a week.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
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.
Time Frame
2 weeks
Title
Generalised Anxiety Disorder 7-item scale (GAD-7)
Description
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.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Swedish resident
Valid e-mail address
18 years old or older
PHQ-9 score of 5-20
GAD-7 score of 5-15
Exclusion Criteria:
suicidal thoughts
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30704424
Citation
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.
Results Reference
derived
Learn more about this trial
MyCompass in a Swedish Context - an Automated Self-help Intervention Targeting Mental Health Problems
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