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BLENDING: BLENded care for Depressive symptoms IN General practice: a randomised non-inferiority trial

BLENDING: BLENded care for Depressive symptoms IN General practice: a randomised non-inferiority trial - BLENDING

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40697
Enrollment
302
Registered
2015-02-11
Start date
2016-01-15
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depressive disorder depressive symptoms

Interventions

Intervention: E-prescription to an online self-management program (1-2 sessions per week spread over 5-10 weeks), blended with a few telephonic or face-to-face contacts with the GP or POH-GGZ.

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: Adult patients, i.e. aged 18 or over; Patients presenting to the GP with a depressive disorder or depressive symptoms; Patients for whom GP considers prescribing an antidepressant.

Exclusion criteria

Exclusion criteria: Patients will excluded if they: - are unwilling to accept randomization to either a psychological (e-prescription) or care as usual. - have an anxiety disorder or obsessive compulsive disorder as primary diagnosis - have current substance abuse (alcohol, drugs) - receive currently treatment for depression (i.e. medication or e-mental health intervention) - have an insufficient command of the Dutch language - have not given an informed consent - No internet available or grossly insufficient computer skills

Design outcomes

Secondary

MeasureTime frame
Secondary endpoints are the reduction on depressive symptoms using the HRSD-17 at 12 months, percentage response (50% reduction in symptoms on HRSD-17), remission (HRSD-17 score below 7) at three and twelve months of follow-up, antidepressant use, effect on general health status, functional impairment, treatment satisfaction and cost-effectiveness.

Primary

MeasureTime frame
Main study parameters/endpoints: Main endpoint is the reduction in depressive symptoms as assessed by the Hamilton Depression Rating Scale-17 (HRSD-17) from baseline to three months after intervention.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)