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OpenTrials
Completed

NCT Number: NCT03691116

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.

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Key information

Conditions

Mental Health Behavior Motor Activity Personal Satisfaction Primary Health Care Psychological Well-Being Risk Reduction Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liljeholmens Primary Healthcare Center

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Children under 18 years.

Treatment and study plan

Digital Health Profile

Behavioral

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

Behavioral

Ordinary psychological assessment and counseling.

Primary outcomes

  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 outcomes

  1. Lifestyle habits

    Time frame: 10 weeks

    Self administered lifestyle scores,

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • The Swedish Research Council

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Oct 1, 2018
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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