Digital Self-help Support for Lifestyle Behavior Changes Among Primary Care Outpatients With Mental Health Problems
Feasibility and Effectiveness of Digital Self-help Support for Lifestyle Behavior Changes Among Primary Care Outpatients With Mental Health Problems
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 Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Stockholm, Sweden
- Liljeholmens Primary Healthcare Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients that seeks psychological treatment during the time period when the study is ongoing.
Exclusion Criteria:
- Children under 18 years.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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)
|
Screening, health check-up and automatic feedback in the areas tobacco, alcohol, exercise and diet, used on a National digital platform (Stöd och Behandlingsplattformen, SoB)
Ordinary psychological assessment and counseling.
|
|
Active Comparator: Treatment as usual
Psychological assessment and treatment as usual.
|
Ordinary psychological assessment and counseling.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire (PHQ-9)
Time Frame: 10 weeks
|
Self administered depression scores
|
10 weeks
|
|
Generalized Anxiety Disorder (GAD-7)
Time Frame: 10 weeks
|
Self administered anxiety scores
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lifestyle habits
Time Frame: 10 weeks
|
Self administered lifestyle scores,
|
10 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility assessment
Time Frame: 10 weeks
|
Mapping participant lifestyle habits and evaluating whether the model works in ordinary primary care setting. Assessed via patient and staff interviews. |
10 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anne H Berman, PhD, Karolinska Institutet
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2016/1013-31/4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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