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

Mental Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03691116
• Other study ID #: 2016/1013-31/4
• Status: Completed
• Phase: N/A
• Start date: January 23, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: September 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Children under 18 years.

Related Conditions & MeSH terms

• Mental Health
• Primary Health Care
• Risk Reduction Behavior

Intervention

Behavioral:
• Digital Health Profile
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)
• Treatment as usual
Ordinary psychological assessment and counseling.

Locations

Country	Name	City	State
Sweden	Liljeholmens Primary Healthcare Center	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility assessment	Mapping participant lifestyle habits and evaluating whether the model works in ordinary primary care setting.; Assessed via patient and staff interviews.	10 weeks
Primary	Patient Health Questionnaire (PHQ-9)	Self administered depression scores	10 weeks
Primary	Generalized Anxiety Disorder (GAD-7)	Self administered anxiety scores	10 weeks
Secondary	Lifestyle habits	Self administered lifestyle scores,	10 weeks