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

• ClinicalTrials.gov Identifier: NCT03659630
• Recruitment Status: Completed
• First Posted: September 6, 2018
• Last Update Posted: September 9, 2021
• Sponsor: Karolinska Institutet
• Information provided by (Responsible Party): Clara Hellner Gumpert, Karolinska Institutet

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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: December 2015
• Actual Primary Completion Date: January 2017
• Actual Study Completion Date: January 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) [ 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. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nilsson A, Sörman 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.

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

Individual Participant Data (IPD) Sharing Statement:

• 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; Behavioral Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders