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Trial record 12 of 236 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

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

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

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 Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

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.




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.




Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691116


Contacts
Contact: Karoline Kolaas, MSc +46736556991 karoline.kolaas@ki.se
Contact: Anne H Berman, PhD +46704245360 anne.h.berman@ki.se

Locations
Sweden
Liljeholmens Primary Healthcare Center Recruiting
Stockholm, Sweden
Contact: Karoline Kolaas, MSc    +46736556991    karoline.kolaas@ki.se   
Sponsors and Collaborators
Karolinska Institutet
The Swedish Research Council
Investigators
Principal Investigator: Anne H Berman, PhD Karolinska Institutet

Responsible Party: Anne H Berman, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03691116     History of Changes
Other Study ID Numbers: 2016/1013-31/4
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
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