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

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Completed
• CT.gov ID: NCT03659630
• Collaborator: (none)
• Enrollment: 837
• Arms: 2
• Actual Duration (Months): 13

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Depression; Anxiety State; Sleep Disturbance; Stress, Psychological	Behavioral: MyCompass; Behavioral: Comparison group	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 837 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: MyCompass in a Swedish Context - Lessons Learned From the Transfer of an Automated Self-help Intervention Targeting Mental Health Problems
• Actual Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Patient Health Questionnaire-9 (PHQ-9) [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. Generalised Anxiety Disorder 7-item scale (GAD-7) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Karolinska Institutet

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Clara Hellner Gumpert, Professor, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT03659630
• Other Study ID Numbers: 2015/1268-31/2 + 2016/88
• First Posted: Sep 6, 2018
• Last Update Posted: Sep 9, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dyssomnias; Parasomnias; Stress, Psychological

Study Results

No Results Posted as of Sep 9, 2021