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

NCT ID: NCT03691116

Last Updated: 2020-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-23

Study Completion Date

2020-03-31

Brief Summary

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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

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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.

Conditions

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Mental Health Risk Reduction Behavior Primary Health Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Digital Health Profile

Intervention Type 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

Intervention Type BEHAVIORAL

Ordinary psychological assessment and counseling.

Treatment as usual

Psychological assessment and treatment as usual.

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type BEHAVIORAL

Ordinary psychological assessment and counseling.

Interventions

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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)

Intervention Type BEHAVIORAL

Treatment as usual

Ordinary psychological assessment and counseling.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Children under 18 years.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Anne H Berman

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne H Berman, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Liljeholmens Primary Healthcare Center

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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Kolaas K, Axelsson E, Hedman-Lagerlof E, Berman AH. Healthy lifestyle promotion via digital self-help for mental health patients in primary care: a pilot study including an embedded randomized recruitment trial. Prim Health Care Res Dev. 2023 Sep 20;24:e56. doi: 10.1017/S146342362300049X.

Reference Type DERIVED
PMID: 37728142 (View on PubMed)

Other Identifiers

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2016/1013-31/4

Identifier Type: -

Identifier Source: org_study_id

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