F32 F33
Conditions
Interventions
Group 1: JITAI group: The JITAI arm is the experimental arm. Participants will complete a baseline assessment before starting a three-day calibration period, during which treatment expectations will b
Sponsors
Philipps-Universität Marburg
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: i. Intake of second-generation antidepressant medication (i.e., SSRIs, SNRIs, atypical antidepressants) prescribed for a primary diagnosis of Major Depressive Disorder ii. New intake of, recent switch to, or change in dose regarding the current antidepressant medication with a duration of intake of a minimum of 2 and a maximum of 12 weeks iii. Self-reported depression diagnosis (F32.X or F33.X) iv. Treatment with antidepressants is associated with dysfunctional treatment expectations as evaluated with the Generic Rating Scale for Previous Treatment Experiences, Treatment Expectations, and Treatment Effects (G-EEE) subscale relating to treatment expectations and one item from the Treatment Expectation Questionnaire (TEX-Q14); cut-offs = 4 or = 3 or = 3 or = 4, respectively v. Ability to use digital health interventions through a smartphone application
Exclusion criteria
Exclusion criteria: i. Antidepressant medication was prescribed for a primary diagnosis other than Major Depressive Disorder ii. Current diagnosis or history of psychotic disorder, bipolar disorder, substance abuse disorder iii. Acute suicidality iv. Use of lithium or antipsychotics, with the exception of the augmentation strategies recommended by the National Treatment Guideline (2022) with aripiprazole, olanzapine, quetiapine, and risperidone. v. Treatments that may affect a depressive disorder, as well as antidepressants or the proposed study; simultaneous treatments such as psychotherapy are allowed, provided they are kept constant (inclusion only if the subsequent therapy begins after the intervention [i.e., after post assessment (T6)]), newly started (online) psychotherapy during the intervention phase leads to exclusion if more than 3 sessions have taken place before the post assessment (T6). vi. No ability or access to use digital health interventions through a smartphone application vii. No informed consent viii. Insufficient proficiency of the German language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trajectory of current treatment effects regarding the antidepressant medication over the course of the trial from baseline T0 to post assessment T6 – 'Generic Rating Scale for Previous Treatment Experiences, Treatment Expectations, and Treatment Effects' (G-EEE) subscale for current treatment effects (G-EEE_ACT). The Generic Rating Scale for Previous Treatment Experiences, Treatment Expectations, and Treatment Effects is a self-report questionnaire assessing treatment expectations and experiences with positive and negative treatment effects, as well as potential treatment side effects. The current treatment effects subscale is answered on three items with intensity ratings ranging from 0 (no improvement/worsening/complaints) to 10 (greatest improvement/worsening/complaints imaginable). Measured at baseline (T0), one weekly time point during the intervention phase (t1-t5), one week after completion of the intervention phase (T6). | — |
Secondary
| Measure | Time frame |
|---|---|
| Trajectory of perceived disability over the course of the trial from baseline T0 to post assessment T6 – 'Pain Disability Index' (PDI). The Pain Disability Index is a self-report questionnaire assessing disability and impairment due to chronic pain and is answered on seven items with intensity ratings ranging from 0 (no impairment) to 10 (greatest imaginable impairment). It has been adapted for rating impairment due to antidepressant treatment for the current study. An additional single item assessing overall impairment across various areas of life was adapted from the full length questionnaire. Measured at baseline (T0), at one weekly time point during the intervention phase over the course of 28 days (t1-t5; single item only), one week after completion of the intervention phase (T6). Trajectory of depressive symptoms over the course of the trial from baseline T0 to post assessment T6 – 'Patient Health Questionnaire' (PHQ-2). The Patient Health Questionnaire is a self-report questionnaire assessing the frequency of depressed mood. This version of the questionnaire is answered on two items with four-point frequency ratings ranging from 'not at all' to 'nearly every day'. Measured at baseline (T0), at one weekly time point during the intervention phase over the course of 28 days (t1-t5), one week after completion of the intervention phase (T6). Trajectory of self-reported depressive symptoms over the course of the trial from baseline T0 to one week after completion of the intervention phase (T6) – 'Beck's Depression Inventory' (BDI-II). The Beck's Depression Inventory is a self-report questionnaire assessing the severity and characteristics of depressive symptoms. The range of depressive physical, and cognitive symptoms is assessed on 21 items with severity ratings ranging from 0 (not severe) to 3 (very severe). Measured at baseline (T0), in the middle of the intervention phase (T3), and one week after completion of the intervention phase (T6). Trajectory of e | — |
Countries
Germany
Contacts
Public ContactYvonne Nestoriuc
Helmut-Schmidt-Universität / Universität der Bundeswehr Hamburg
Outcome results
None listed