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

• ClinicalTrials.gov Identifier: NCT03691116
• Recruitment Status: Completed
• First Posted: October 1, 2018
• Last Update Posted: September 9, 2020
• Sponsor: Karolinska Institutet
• Collaborator: The Swedish Research Council
• Information provided by (Responsible Party): Anne H Berman, Karolinska Institutet

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Mental Health; Risk Reduction Behavior; Primary Health Care	Behavioral: Digital Health Profile; Behavioral: Treatment as usual	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility and Effectiveness of Digital Self-help Support for Lifestyle Behavior Changes Among Primary Care Outpatients With Mental Health Problems
• Actual Study Start Date: January 23, 2017
• Actual Primary Completion Date: December 31, 2019
• Actual Study Completion Date: March 31, 2020

Arms and Interventions

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)	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); Behavioral: Treatment as usual; Ordinary psychological assessment and counseling.
Active Comparator: Treatment as usual; Psychological assessment and treatment as usual.	Behavioral: Treatment as usual; Ordinary psychological assessment and counseling.

Outcome Measures

Primary Outcome Measures :

1. Patient Health Questionnaire (PHQ-9) [ Time Frame: 10 weeks ]
   Self administered depression scores
2. Generalized Anxiety Disorder (GAD-7) [ Time Frame: 10 weeks ]
   Self administered anxiety scores

Secondary Outcome Measures :

1. Lifestyle habits [ Time Frame: 10 weeks ]
   Self administered lifestyle scores,

Other Outcome Measures:

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Children under 18 years.

Contacts and Locations

Locations

Sweden

Liljeholmens Primary Healthcare Center

Stockholm, Sweden

Sponsors and Collaborators

Karolinska Institutet

The Swedish Research Council

Investigators

• Principal Investigator: Anne H Berman, PhD; Karolinska Institutet

More Information

• Responsible Party: Anne H Berman, Associate Professor, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT03691116
• Other Study ID Numbers: 2016/1013-31/4
• First Posted: October 1, 2018
• Last Update Posted: September 9, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anne H Berman, Karolinska Institutet:

Mental Health; Digital Intervention; Alcohol; Tobacco; Diet; Physical Activity; Primary Health Care