Digital Self-help Support for Lifestyle Behavior Changes Among Primary Care Outpatients With Mental Health Problems

Not Applicable

Completed

• Conditions: Risk Reduction Behavior; Mental Health; Primary Health Care
• Interventions: Behavioral: Digital Health Profile; Behavioral: Treatment as usual

• Registration Number: NCT03691116
• Lead Sponsor: Karolinska Institutet

Brief Summary

All patients, who have booked a first appointment with a psychologist or counselor at two primary care clinics, are asked to fill out a lifestyle screening questionnaire within the Electronic Medical Record (EMR) system. Up to 150 patients will be screened. The patients who have filled out the first screening and given informed consent are randomized to either Group A: A digital health check-up, with more questions and brief feedback; or Group B: Treatment as usual.

The digital health check-up is based on "Hälsoprofilen", a material that successfully has been used with thousands of patients in Western Sweden. This material generates brief feedback to the patients about the status of their lifestyle behavior and indicates the need for change when necessary for better health. After 10 weeks, the patients fill in the first short screening again. Outcome analyses will compare the two groups.

Detailed Description

The study will be carried out at two primary care clinics in Stockholm. All patients, who have booked a first appointment with a psychologist or counselor at two primary care clinics, are asked to fill out a lifestyle screening questionnaire within the Electronic Medical Record (EMR) system. Up to 150 patients will be screened. The patients who have filled out the first screening and given informed consent are randomized to either Group A: A digital health check-up, with more questions and brief feedback; or Group B: Treatment as usual.

The digital health check-up is based on "Hälsoprofilen", a material that successfully has been used with thousands of patients in Western Sweden. This material generates brief feedback to the patients about the status of their lifestyle behavior and indicates the need for change when necessary for better health. After 10 weeks, the patients fill in the first short screening again. Outcome analyses will compare the two groups.

Study Timeline

• Study Start: 2017-01-23
• Study First Submitted: 2018-09-28
• Study First Submitted QC: 2018-09-28
• Study First Posted: 2018-10-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-03-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-07
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients that seeks psychological treatment during the time period when the study is ongoing.

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Exclusion Criteria

• Children under 18 years.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital Health Profile	Digital Health Profile	A digital health check-up, with questions, brief feedback and information about alcohol, tobacco, diet and exercise, as a complement to treatment as usual. (Psychological assessment and treatment)
Digital Health Profile	Treatment as usual	A digital health check-up, with questions, brief feedback and information about alcohol, tobacco, diet and exercise, as a complement to treatment as usual. (Psychological assessment and treatment)
Treatment as usual	Treatment as usual	Psychological assessment and treatment as usual.

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-9)	10 weeks	Self administered depression scores
Generalized Anxiety Disorder (GAD-7)	10 weeks	Self administered anxiety scores

Secondary Outcome Measures

Name	Time	Method
Lifestyle habits	10 weeks	Self administered lifestyle scores,

Trial Locations

Locations (1)

Liljeholmens Primary Healthcare Center; 🇸🇪 Stockholm, Sweden