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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03659630
Other study ID # 2015/1268-31/2 + 2016/88
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2015
Est. completion date January 2017

Study information

Verified date September 2021
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The study also investigates the usage of a specially designed research platform aimed at handling informed consent and online surveys.


Recruitment information / eligibility

Status Completed
Enrollment 837
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
MyCompass
Self-help tools to change behaviours in various different domains including sleep deprivation, anxiety and depression.
Comparison group
An email containing a brief text on general tips regarding mental health was sent out once a week.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 weeks
Primary 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. 2 weeks
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