NCT03691116

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 23, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

2.9 years

First QC Date

September 28, 2018

Last Update Submit

September 7, 2020

Conditions

Mental HealthRisk Reduction BehaviorPrimary Health Care

Keywords

Mental HealthDigital InterventionAlcoholTobaccoDietPhysical ActivityPrimary Health Care

Outcome Measures

Primary Outcomes (2)

  • Patient Health Questionnaire (PHQ-9)

    Self administered depression scores

    10 weeks

  • Generalized Anxiety Disorder (GAD-7)

    Self administered anxiety scores

    10 weeks

Secondary Outcomes (1)

  • Lifestyle habits

    10 weeks

Other Outcomes (1)

  • Feasibility assessment

    10 weeks

Study Arms (2)

Digital Health Profile

EXPERIMENTAL

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 ProfileBehavioral: Treatment as usual

Treatment as usual

ACTIVE COMPARATOR

Psychological assessment and treatment as usual.

Behavioral: Treatment as usual

Interventions

Digital Health ProfileBEHAVIORAL

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)

Digital Health Profile
Treatment as usualBEHAVIORAL

Ordinary psychological assessment and counseling.

Digital Health ProfileTreatment as usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Children under 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liljeholmens Primary Healthcare Center

Stockholm, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 37728142DERIVED

MeSH Terms

Conditions

Psychological Well-BeingRisk Reduction BehaviorMotor Activity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Anne H Berman, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 28, 2018

First Posted

October 1, 2018

Study Start

January 23, 2017

Primary Completion

December 31, 2019

Study Completion

March 31, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)