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

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT03691116
Collaborator
The Swedish Research Council (Other)
150
1
2
38.2
3.9

Study Details

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
  • Behavioral: Digital Health Profile
  • Behavioral: Treatment as usual
N/A

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
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 :
Jan 23, 2017
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Mar 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) [10 weeks]

    Self administered depression scores

  2. Generalized Anxiety Disorder (GAD-7) [10 weeks]

    Self administered anxiety scores

Secondary Outcome Measures

  1. Lifestyle habits [10 weeks]

    Self administered lifestyle scores,

Other Outcome Measures

  1. Feasibility assessment [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Site City State Country Postal Code
1 Liljeholmens Primary Healthcare Center Stockholm Sweden

Sponsors and Collaborators

  • Karolinska Institutet
  • The Swedish Research Council

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anne H Berman, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT03691116
Other Study ID Numbers:
  • 2016/1013-31/4
First Posted:
Oct 1, 2018
Last Update Posted:
Sep 9, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
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, Associate Professor, Karolinska Institutet

Study Results

No Results Posted as of Sep 9, 2020