Major Depressive Disorder / Depression
Conditions
Interventions
The Cognitive Restructuring (CR) and Behavioral Activation (BA) modules come
from the STARr Training. STARr is developed and researched by researchers of
the Trimbos Instituut, Utrecht University an
Weisz et al., 2012). For this
Single Case study the modules have been adapted to an individualized format,
suitable for (severely) depressed adolescents. Each module consists of three
sessions, one
understand the relation between events and their
cognitions, feelings, and behaviors
challenge unhealthy cognitions
create
new, healthier cognitions. Each of the three sessions, adolescents take a step
further in this learning process, according to the following content:
Session 1: psycho-education on (identifyin
basic emotions such as joy and anger, and more complicated
emotions
one*s behavior
how events, cognitions, feelings and behavior are
linked. Then automatic thought processes and the distinction between healthy
(helpful) and unhealthy (unhelpful) thoughts are introduced. Finally,
Sponsors
GGZ Oost Brabant (Rosmalen)
Eligibility
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: * age between 12-18 years old; * sufficient knowledge of the Dutch language; * diagnosed with a major depressive disorder with the K-SADS
Exclusion criteria
Exclusion criteria: * absence of adolescents* or parental permission (for subjects aged younger than 16) * acute and severe suicidal thoughts and/or intentions * recently introduced medication that has not yet stabilized / changes in antidepressant medication during the period of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| i. Primary study parameters Parameters concerning the adolescents. These parameters will be addressed via the daily questionnaires. * The core symptoms of depression will be assessed using the Patient Health Questionnaire-2 (PHQ-2: Löwe, Kroenke, & Gräfe, 2004). The PHQ contains two items, namely *feeling down, depressed or hopeless*, and *little interest or pleasure in doing things*. Both items assess symptomatology on a 4-point scale ranging from *not at all* to *nearly every day*. The PHQ-2 has sufficient to great sensitivity and specificity (Kroenke, Spitzer & Williams, 2003). The PHQ-2 can be used in children of aged 12 and older. Assessment at daily questionnaires * Other EMA items of potential influence on the primary study parameter (PHQ-2). We want to know whether important life events occurred during the course, by asking (*). Furthermore we measured EMA items that have proven useful in previous EMA studies: *I found the activity I was doing pleasurable* (translated from *De activiteit waar ik mee bezig was vond ik plezierig om te doen*), *the activity I was doing cost me a lot of energy* (translated from *De activiteit waar ik mee bezig was kostte energie*), *today was stressful so far* (translated from *Vandaag was tot nu toe stressvol*). Assessment at daily questionnaires * Treatment adherence by monitoring how many times the exercises from the CBT were performed, by asking *how many times did you perform the instructions or exercises from the CBT course today?* (translated from *Hoe vaak heb je vandaag de instructies of oefeningen uit de cursus toegepast?*). Assessment at daily questionnaires | — |
Secondary
| Measure | Time frame |
|---|---|
| ii. Secondary study parameters/endpoints Parameters concerning the adolescents that will be addressed via digital questionnaires (T0-T4). Also included is the parameter Treatment integrity. * Demographic information of the adolescent will be gathered by adding questions about gender, age, ethnicity, education level, family income and/or experience to the self-report questionnaires. Assessment at T0 * Presence of a depression diagnosis will be measured by a semi-structured diagnostic interview using the Kiddie-Schedule for Affective Disorders and Schizophrenia, present and lifetime version (K-SADS-PL; Kaufman et al., 1997; Reichart, Wals, & Hillegers, 2000). In this schedule, the view of the adolescent, the parent and the independent clinician can be taken into account. The schedule can be used to assess 33 different disorders, including anxiety disorders, psychotic disorders, and affective disorders. Previous research supports the concurrent and convergent validity of the K-SADS, and provides excellent interrater agreement (range: 93% to 100%) and test-retest reliability (.77 to 1.00) (Kaufman et al., 1997; Lauth et al., 2010). The K-SADS-PL can be used for children age 6-18. Assessment at T0, T4 * Depression severity will be rated by an independent researcher on the K-SADS-PL. Assessment at T0 and T4 * Comorbidity will be assessed with the Brief Problem Monitor (BPM; Achenbach, McConaughy, Ivanova, & Rescorla, 2011). The BPM is an abbreviated version of the Child Behavior Checklist, and comprises three scales: internalizing, externalizing and attention. In total the BPM contains 19 items, which are rated on a 3-point scale ranging from *not true* to *very true*. Psychometric properties are qualified as good, with a high overall internal consistency (Chronbach*s alpha=0.91), sufficient internal consistency for the subscales (Chronbachs alpha between 0.78 and 0.87), and high sensitivity (Achenbach, McConaughy, Ivanova, & Rescorla, 2011; | — |
Countries
Netherlands
Outcome results
None listed