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Therap-i: A personalized monitoring and feedback tool as an add-on to support standard treatment for depression.

Therap-i: A personalized monitoring and feedback tool as an add-on to support standard treatment for depression. - Therap-i

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46281
Enrollment
100
Registered
2018-11-15
Start date
2019-06-27
Completion date
Unknown
Last updated
2024-06-18

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

Conditions

depression major depressive disorder

Interventions

In the Therap-i module patients will systematically self-monitor their affect and person specific factors five times a day for two months with an electronic diary. The diary items are based on patie

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Main diagnosis is Major Depressive Disorder (MDD) according to the DSM-V - Age between 18-65 years - Patients have previously received a primary protocolled psychological/psychotherapeutic intervention for depression, consisting of four months of (cognitive) behavioural therapy, interpersonal therapy or brief psychodynamic therapy, which is evaluated as not effective (enough) to repeat or continue by the clinician responsible for the patient. - Patients start or receive policlinic psychological treatment wherein they have weekly one-on-one consults with a therapist for at least 8 weeks

Exclusion criteria

Exclusion criteria: - A current diagnosis of: * MDD with psychotic features * bipolar disorder * substance-related and addictive disorder * schizophrenia spectrum and other psychotic disorder * neurocognitive disorder - Previous treatment with Electroconvulsive Therapy - Visual impairments that cannot be corrected - Insufficient mastery of the Dutch language - Inability or unwillingness to manage a smartphone

Design outcomes

Primary

MeasureTime frame
The primary outcome measures to determine efficacy of the intervention will be the change in depressive symptom severity, as measured by the Inventory of Depressive Symptomatology self-report (IDS-SR).

Secondary

MeasureTime frame
Secondary outcome measures to determine efficacy of the Therap-i module are changes in i) psychological functioning as measured by the Outcome Questionnaire (OQ-45), ii) illness perception as measured by the Illness Perception Questionnaire Mental Health (IPQ-MH), iii) therapeutic alliance as measured by the Work Alliance Inventory (WAI). A descriptive outcome measure to determine efficacy of the Therap-i module are differences between the treatment arms in self-management as measured by the Questionnaire Self-Management in Recovery from Depression (Vragenlijst zelfmanagement bij herstel van depressie; QSRD).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)