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Mental DisordersSGE-PsyScanNCT01971307

Supporting Primary Care in Diagnosis and Choice of Treatment for Patients With Psychosocial Symptoms: SGEPsyScan.

A study testing SGE-PsyScan in people with Mental Disorders, run by Maastricht University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Although effective treatments for psychosocial symptoms and disorders are available, patients frequently do not receive the most appropriate and effective treatment for their symptoms because of inappropriate and unstructured diagnostics of psychosocial symptoms in general practice. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mental Disorders
What is being tested?
SGE-PsyScan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
336 participants
Where
1 siteNetherlands
Study dates
Dec 2013to Sep 2015
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with (suspected) psychosocial symptoms
  • Aged 18 years or older and capacitated
  • Adequate understanding of Dutch language
  • Able to perform SGE-PsyScan at home, individually

Who cannot join

  • Clear and treatable somatic causes of symptoms
  • Acute distress/danger
  • No written informed consent

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Stichting Gezondheidscentra Eindhoven

    Eindhoven, 5605 LS

Other trials in Netherlands

About this study

Although effective treatments for psychosocial symptoms and disorders are available, patients frequently do not receive the most appropriate and effective treatment for their symptoms because of inappropriate and unstructured diagnostics of psychosocial symptoms in general practice. The hypothesis is that by using the intervention SGE-PsyScan the clinical symptoms of patients can be assessed more uniformly and earlier as opposed to the GPs' assessment in usual care. As a result, patients are supposed to start earlier with a treatment that fits the type and severity of their symptoms better.

The patients will be randomly assigned to either receive the SGE-PsyScan or usual care.

Being tested
SGE-PsyScan
Medical subject headings
Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SGE-PsyScanOther

Study groups in NCT01971307
Study groupRoleWhat they receive
SGE-PsyScanExperimentalThe SGE-PsyScan is an internet application to which the General Practitioner (GP) refers the patient, which includes the distress screener, the 4-Dimensional Symptom Questionnaire (4DSQ) and a series of additional questions for differentiating between stress, depressive, anxious and somatization symptoms. Based on the 4DSQ patients and GPs receive advices for possible treatments.
Receives: Other: SGE-PsyScan
Usual careNo interventionUsual care for persons with psychosocial symptoms and disorders in Dutch primary care includes all usual care procedures; preventive, screening, diagnostic, (non-)pharmacological or therapeutic procedures which are routinely used in everyday care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The rate of patients who achieve a successful decrease in the level of psychosocial symptoms as measured with the Symptom Checklist 90 (SCL-90) after 12 months. A successful treatment result is defined as a decrease in the SCL-90 patient score of 50%.

    Measured: 12 months

Secondary outcomes (13)

  1. The level of psychosocial symptoms of patients as measured with the SCL-90

    Measured: 3 months

  2. The level of psychosocial symptoms of patients as measured with the SCL-90

    Measured: 6 months

  3. Health technology assessment

    We will measure direct and indirect costs in both groups with the Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P) and Electronic Medical Records (EMR) parameters indicating relevant expenditures including treatments, consultations and referrals

    Measured: 3 months

  4. Health technology assessment

    We will measure direct and indirect costs in both groups with the Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P) and Electronic Medical Records (EMR) parameters indicating relevant expenditures including treatments, consultations and referrals

    Measured: 6 months

  5. Health technology assessment

    We will measure direct and indirect costs in both groups with the Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P) and Electronic Medical Records (EMR) parameters indicating relevant expenditures including treatments, consultations and referrals

    Measured: 9 months

  6. Health technology assessment

    We will measure direct and indirect costs in both groups with the Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P) and Electronic Medical Records (EMR) parameters indicating relevant expenditures including treatments, consultations and referrals

    Measured: 12 months

  7. Quality of life will be measured using the EuroQol-5Dimensions-5Levels (EQ-5D-5L) questionnaire

    Measured: 3 months

  8. Quality of life will be measured using the EuroQol-5Dimensions-5Levels (EQ-5D-5L) questionnaire

    Measured: 6 months

  9. Quality of life will be measured using the EuroQol-5Dimensions-5Levels (EQ-5D-5L) questionnaire

    Measured: 12 months

  10. The extent of patient satisfaction with the care they receive, will be measured using the Patient Assessment of Chronic Illness Care (PACIC)

    Measured: 3 months

  11. The extent of patient satisfaction with the care they receive, will be measured using the Patient Assessment of Chronic Illness Care (PACIC)

    Measured: 6 months

  12. The extent of patient satisfaction with the care they receive, will be measured using the Patient Assessment of Chronic Illness Care (PACIC)

    Measured: 12 months

  13. Electronic medical records parameters

    Relevant psychosocial care parameters will be extracted from the EMR to monitor changes in care patterns including previous psychosocial episodes, numbers and types of psychosocial diagnoses, use of screening/diagnostic instruments, comorbidity, treatments, medication prescriptions, referrals and health care consumption.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
336 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01971307
Sponsor's protocol ID
NL44597.068.13/ METC 13-3-034
Acronym
SGE-PsyScan
Status last verified
Dec 2015
First submitted
11 Oct 2013
Last updated
22 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Gidding LG, Spigt M, Winkens B, Herijgers O, Dinant GJ. PsyScan e-tool to support diagnosis and management of psychological problems in general practice: a randomised controlled trial. Br J Gen Pract. 2018 Jan;68(666):e18-e27. doi: 10.3399/bjgp17X694109. Epub 2017 Dec 18.

    PubMed 29255109

Questions about this trial

What is this clinical trial studying?

A study testing SGE-PsyScan in people with Mental Disorders, run by Maastricht University Medical Center at 1 site in Netherlands.

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 4 inclusion and 3 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 22 Dec 2015. 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 Netherlands. 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?

The rate of patients who achieve a successful decrease in the level of psychosocial symptoms as measured with the Symptom Checklist 90 (SCL-90) after 12 months. A successful treatment result is defined as a decrease in the SCL-90 patient score of 50%. (time frame: 12 months). 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 NCT01971307, 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 22 Dec 2015.

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