F31.3-F33.9 (Patients with a diagnosis of unipolar or bipolar depression, either currently experiencing an acute depressive episode or in partial remission, presenting with at least mild depressive symptoms and mild to moderate cognitive impairment)
Conditions
Interventions
Group 1: Participants will undergo three assessment time points. These include interviews regarding psychopathological symptoms, neurocognitive testing, and magnetic resonance imaging (MRI) scans. Bet
Sponsors
Klinik für Psychiatrie, Psychosomatik und Psychotherapie, Universitätsklinikum Frankfurt
Eligibility
Sex/Gender
All
Age
18 Years to 30 Years
Inclusion criteria
Inclusion criteria: • Age between 18 and 30 years (meta-analytic evidence suggests particularly strong effects of cognitive remediation within this age range). • Diagnosis of unipolar or bipolar depressive disorder according to DSM-5 criteria (not necessarily meeting the criteria at study entry) • No changes to the current treatment regimen, particularly psychopharmacological treatment, within the past 4 weeks (to reduce potential confounding by concurrent treatment effects). • At least mild depressive symptom severity, defined as a Patient Health Questionnaire-9 (PHQ-9) score = 10. • At least mild to moderate subjective cognitive impairment, defined as either a Perceived Deficits Questionnaire for Depression (PDQ-D-20) total score = 40 (mean item score = 2.0, corresponding to at least “sometimes” across domains), or a subscale score = 15 in at least two of the four assessed cognitive domains (mean item score = 3.0, corresponding to at least “often”). • Subjectively perceived cognitive deficits must be attributable to the depressive syndrome, operationalized as either (a) the first onset of cognitive difficulties occurring in temporal association with a depressive episode, or (b) a clearly perceived worsening of pre-existing cognitive difficulties during depressive episodes. • Capacity to provide informed consent. • Sufficient proficiency in German (minimum B2 level or equivalent) to understand complex questionnaires, participate in German-language interviews and group sessions, and follow written instructions in German.
Exclusion criteria
Exclusion criteria: • History of neurological disorders (e.g., dementia, acquired brain injury). • Mental disorders attributable to a medical or neurological condition. • Psychiatric exclusion criteria - Current substance use in individuals with a substance use disorder. Participation is only permitted following at least 6 months of abstinence, as ongoing substance use may adversely affect both cognitive functioning and adherence to the cognitive remediation program. - Current or lifetime diagnosis of a schizophrenia spectrum disorder according to DSM-5 criteria. Cognitive deficits associated with schizophrenia spectrum disorders differ substantially from depression-related cognitive dysfunction with regard to their profile, severity, and underlying neurobiological mechanisms. - Current diagnosis of post-traumatic stress disorder (PTSD) without ongoing or completed trauma-focused treatment. Trauma-related dissociation as well as persistent impairments in attention and memory may interfere with both the effectiveness and the assessment of cognitive remediation. - Current diagnosis of attention-deficit/hyperactivity disorder (ADHD). Cognitive deficits associated with ADHD are based on distinct etiological and neurobiological mechanisms, limiting comparability with depression-related cognitive dysfunction, particularly within a small pilot sample. - Other comorbid mental disorders do not constitute exclusion criteria per se. • Additional exclusion criteria for MRI participation - Pregnancy. - Implanted electronic medical devices (e.g., cardiac pacemakers, medication pumps). - Non-removable ferromagnetic objects. - Tattoos located in the head, neck, or genital region, or tattoos exceeding 20 cm in length. - Severe claustrophobia. - Note: Individuals with fixed orthodontic retainers and tattoos outside sensitive body regions (= 20 cm in length) may be included following an individual risk assessment, comprehensive study information, and written informed consent. - Note: Exclusion from MRI participation does not constitute exclusion from the study as a whole. Participants who are ineligible for MRI assessment may still take part in all non-MRI study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence to the intervention program: The primary feasibility outcome of the pilot study is a participant-level composite adherence score, calculated for each participant as the mean of the following three indicators: (1) the proportion of completed daily smartphone-based assessments (m-Path), (2) the proportion of completed CogniFit training sessions, and (3) the proportion of attended cognitive remediation sessions. A second primary feasibility outcome is the study dropout rate, defined as the proportion of participants who discontinue participation before study completion. In addition, each of the three adherence indicators will be reported descriptively and analyzed separately to identify potential areas for optimization of the study procedures. These outcomes will be calculated following completion of the third assessment time point. | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility-related outcomes: • Participant feedback: Structured qualitative and quantitative evaluation of the acceptability, burden, and satisfaction associated with the study procedures, assessed via a semi-structured feedback interview at T2 (approximately 60 minutes, conducted by telephone). The interview will combine closed-ended Likert-scale items with open-ended questions addressing participants’ subjective experiences. Findings will inform optimization of the study procedures for the subsequent main trial. • Recruitment feasibility: Number of screened and enrolled participants, as well as recruitment duration. Changes in individual symptom networks: • Network parameters reflecting the centrality of cognitive dysfunction within individual symptom networks. • Changes in edge weights between cognitive deficits and depressive and anxiety symptoms from the baseline phase to the cognitive remediation phase. Cognitive functioning: • Performance on neuropsychological test batteries at T0, T1, and T2. • Weekly cognitive assessment scores obtained through CogniFit. • Daily self-reported cognitive deficits. Depressive and anxiety symptomatology: • Interview-based assessment of psychopathological symptoms at T0, T1, and T2. • Daily self-reported depressive and anxiety symptoms. Neurobiological measures: • Structural brain network characteristics, including white matter tract integrity, assessed at T0, T1, and T2. • Functional brain network characteristics, including resting-state functional connectivity, assessed at T0, T1, and T2. • Associations between neurobiological measures and treatment response. | — |
Countries
Germany
Contacts
Public ContactMarius Gruber
Klinik für Psychiatrie, Psychosomatik und Psychotherapie, Arbeitsgruppe Predictive Psychiatry, Universitätsklinikum Frankfurt
Outcome results
None listed