Mental HealthNCT03691116
Digital Self-help Support for Lifestyle Behavior Changes Among Primary Care Outpatients With Mental Health Problems
A study testing Digital Health Profile and Treatment as usual in people with Mental Health and Risk Reduction Behavior, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Risk Reduction Behavior, Primary Health Care
- What is being tested?
- Digital Health Profile and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 23 Jan 2017to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients that seeks psychological treatment during the time period when the study is ongoing.
Who cannot join
- Children under 18 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Effectiveness of 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.
Read the 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.
- Conditions
- Mental Health, Risk Reduction Behavior, Primary Health Care
- Being tested
- Digital Health Profile, Treatment as usual
- Keywords
- Mental Health, Digital Intervention, Alcohol, Tobacco, Diet, Physical Activity, Primary Health Care
- Medical subject headings
- Psychological Well-Being, Risk Reduction Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Health ProfileBehavioural
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 usualBehavioural
Ordinary psychological assessment and counseling.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: Digital Health Profile; Behavioral: Treatment as usual |
| Treatment as usual | Active comparator | Psychological assessment and treatment as usual. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ-9)
Self administered depression scores
Measured: 10 weeks
Generalized Anxiety Disorder (GAD-7)
Self administered anxiety scores
Measured: 10 weeks
Secondary outcomes (1)
Lifestyle habits
Self administered lifestyle scores,
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start23 Jan 2017
- Primary completion31 Dec 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Responsible party
- Principal investigator, Anne H Berman, Karolinska Institutet
- Investigators
- Anne H Berman, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691116
- Sponsor's protocol ID
- 2016/1013-31/4
- Status last verified
- Sep 2020
- First submitted
- 28 Sep 2018
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37728142
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of Digital Self-help Support for Lifestyle Behavior Changes Among Primary Care Outpatients With Mental Health Problems
- ClinicalTrials.gov ID
- NCT03691116
- Acronym / sponsor ID
- 2016/1013-31/4
- Conditions
- Mental Health, Risk Reduction Behavior, Primary Health Care
- Keywords
- Mental Health, Digital Intervention, Alcohol, Tobacco, Diet, Physical Activity, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Health Profile | Experimental | Behavioral: Digital Health Profile, Behavioral: Treatment as usualA 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) |
| Treatment as usual | Active comparator | Behavioral: Treatment as usualPsychological assessment and treatment as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients that seeks psychological treatment during the time period when the study is ongoing.
Key exclusion criteria (1 listed)
- Children under 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Health ProfileScreening, health check-up and automatic feedback in the areas tobacco, alcohol, exercise and diet, used on a National digital platform (Stöd och Behandlingsplattformen, SoB) | Behavioural | Digital Health Profile |
| Treatment as usualOrdinary psychological assessment and counseling. | Behavioural | Digital Health Profile, Treatment as usual |
Primary outcome
Patient Health Questionnaire (PHQ-9)
Time frame: 10 weeks
Self administered depression scores
Generalized Anxiety Disorder (GAD-7)
Time frame: 10 weeks
Self administered anxiety scores
1 secondary outcome
Lifestyle habits
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Derived from this study: PubMed 37728142Kolaas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne H Berman, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Health Profile and Treatment as usual in people with Mental Health and Risk Reduction Behavior, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (PHQ-9) (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03691116, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.