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

Recruiting

Conditions: depression
major depressive disorder
10027946

Registration Number: NL-OMON46281

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

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

- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measures to determine efficacy of the intervention will be<br /><br>the change in depressive symptom severity, as measured by the Inventory of<br /><br>Depressive Symptomatology self-report (IDS-SR). </p><br>

Secondary Outcome Measures

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