MyCompass in a Swedish Context - an Automated Self-help Intervention Targeting Mental Health Problems

September 1, 2021 updated by: Clara Hellner Gumpert, Karolinska Institutet

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

837

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention group
The intervention group receives the MyCompass intervention, an automated self-help intervention for mild to moderate mental ill-health.
Behavioral: MyCompass
Self-help tools to change behaviours in various different domains including sleep deprivation, anxiety and depression.
PLACEBO_COMPARATOR: Comparison group
The control group receives a brief email each week, describing the most common mental health issues.
Behavioral: Comparison group
An email containing a brief text on general tips regarding mental health was sent out once a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks
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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2015

Primary Completion (ACTUAL)

January 1, 2017

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

September 3, 2018

First Submitted That Met QC Criteria

September 3, 2018

First Posted (ACTUAL)

September 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2021

Last Update Submitted That Met QC Criteria

September 1, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/1268-31/2 + 2016/88

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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