NCT01971307

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
336

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

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

First Submitted

Initial submission to the registry

October 11, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 29, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

December 22, 2015

Status Verified

December 1, 2015

Enrollment Period

1.8 years

First QC Date

October 11, 2013

Last Update Submit

December 21, 2015

Conditions

Mental Disorders

Outcome Measures

Primary Outcomes (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%.

    12 months

Secondary Outcomes (13)

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

    3 months

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

    6 months

  • Health technology assessment

    3 months

  • Health technology assessment

    6 months

  • Health technology assessment

    9 months

  • +8 more secondary outcomes

Other Outcomes (1)

  • Health care provider satisfaction with the Assessment of Chronic Illness Care (ACIC)

    12 months

Study Arms (2)

SGE-PsyScan

EXPERIMENTAL

The 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.

Other: SGE-PsyScan

Usual care

NO INTERVENTION

Usual 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.

Interventions

SGE-PsyScanOTHER
SGE-PsyScan

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stichting Gezondheidscentra Eindhoven

Eindhoven, 5605 LS, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 29255109DERIVED

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Mark G Spigt, PhD

    Research Institute CAPHRI, Department of Family Medicine, Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2013

First Posted

October 29, 2013

Study Start

December 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

December 22, 2015

Record last verified: 2015-12

Locations

NL(1)