NCT03659630

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
837

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

1.1 years

First QC Date

September 3, 2018

Last Update Submit

September 1, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group receives the MyCompass intervention, an automated self-help intervention for mild to moderate mental ill-health.

Behavioral: MyCompass

Comparison group

PLACEBO COMPARATOR

The control group receives a brief email each week, describing the most common mental health issues.

Behavioral: Comparison group

Interventions

MyCompassBEHAVIORAL

Self-help tools to change behaviours in various different domains including sleep deprivation, anxiety and depression.

Intervention group

An email containing a brief text on general tips regarding mental health was sent out once a week.

Comparison group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Swedish resident
  • Valid e-mail address
  • years old or older
  • PHQ-9 score of 5-20
  • GAD-7 score of 5-15

You may not qualify if:

  • suicidal thoughts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Anxiety DisordersParasomniasStress, Psychological

Condition Hierarchy (Ancestors)

Mental DisordersSleep Wake DisordersNervous System DiseasesBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 3, 2018

First Posted

September 6, 2018

Study Start

December 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

September 9, 2021

Record last verified: 2021-09