Multimodal Study of the Outcomes of Psychoanalyses of Patients Suffering from Chronic Depression with Early Trauma in Lausanne (MODE-L).

Germany, Switzerland, United States (ICTRP)

ID di studio ICTRP
DRKS00016872 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
Practicability Study for the Multimodal Outcome Study of Psychoanalyses of Chronically Depressed Patients with Early Trauma in Lausanne (MODE-L) (BASEC)

Titolo accademico
Multimodal Outcome Study of Psychoanalyses of Chronically Depressed Patients with Early Trauma - MODE (ICTRP)

Titolo pubblico
Multimodal Outcome Study of Psychoanalyses of Chronically Depressed Patients with Early Trauma (ICTRP)

Malattie studiate

F33Recurrent depressive disorder (ICTRP)

Intervento studiato
Group 1: Psychoanalytical longterm treatment with 1 weekly session
Group 2: Psychoanalytical longterm treatment with 3-4 weekly session
Group 3: Healthy control group (ICTRP)

Tipo di studio
interventional (ICTRP)

Disegno dello studio
Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: treatment (ICTRP)

Criteri di inclusione/esclusione
Inclusion criteria: Diagnosis of major depression or dysthymia (based on Structural Clinical Interview-SCID) for at least 12 months
QIDS-C score > 9, BDI 2 > 17
Age: 21-60 years
CTQ: at least trauma at one of the subscales (selfratings of the patients, ratings of SCID interviewer)
Sufficient knowledge of local language
Informed consent to study protocol
Willing to be treated without antidepressand medication for one year (except in emergency situations) (ICTRP)

Exclusion criteria: Current or past psychotic symptomatology, schizoaffective, schizophrenic, or bipolar affective disorder
Substance dependence current or during the last three years
Dementia
Borderline, schizotypal and antisocial personality disorder
Acute suicidality
Restriction of intellectual capacity
Serious physical illness that strongly affects the depression or is causal for the depression
Concurrent psychotherapeutic treatment
Technical exclusion criteria for MRI (metallic tattoos, pacemakers, or other metal parts in the body etc., according to special guidelines of the local MRI teams

Endpoint primari e secondari
Primary Outcomes: MRI Brain Measures
Assessment will comprise the following MRI brain measures. Anatomical MRI: measures of cortical thickness at all points across the cerebrum. Resting State Functional MRI (rsfMRI): measures of functional connectivity throughout the brain. Cyberball Task-Related Functional MRI (fMRI): measures of brain activation throughout the brain in response to trust, mistrust (social exclusion), and rebuilding of trust (social re-inclusion). Diffusion Tensor Imaging (DTI): measures of fractional anisotropy and average diffusion coefficient.
What these outcomes tell us about the brain MRI is an entirely safe way of imaging the brain at any age. It is routinely performed in unsedated people at multiple time points, including multiple time points within an RCT, and without the need for exposure to any radioactivity. MRI scanning can be performed in different modes, with each modality providing unique information probing different aspects of the brain�s structural and functional organization. Anatomical MRI provides information about brain structure, most commonly the volumes and shapes of particular brain regions. Diffusion Tensor Imaging (DTI) provides information about tissue organization within the brain, especially white matter fibers that connect one brain region to another. At each voxel, Fractional Anisotropy (FA) measures the directional diffusion of water, Mean Diffusivity (MD) measures the overall diffusion of water, Axial Diffusivity (AD) measures diffusion along the long axis of diffusion, which is presumed to be along the long axis of the fiber bundle, and Radial Diffusivity (RD) measures diffusion perpendicular to the long axis of diffusion or fiber bundle. Functional MRI (fMRI) provides measures of time-dependent changes in the relative concentration of deoxyhemoglobin within each voxel, which itself is driven largely by changes in oxygen use and the underlying changes in neuronal activity within the voxel. Measures of resting state connectivity (rsfMRI) are in essence measures of cross-correlation for the fMRI series of two different voxels (i.e., two different points in the brain), which assesses how strongly those two regions communicate with one another over time.

(ICTRP)

Secondary outcome measures
MODE will investigate whether and how brain changes are associated with common measures of change for patients with chronic depression and early trauma after one year of treatment. To achieve this aim and as recommended in meta-analytic reviews, various broad areas of patient�s functioning are assessed including (1) psychopathology, (2) personality, social and work functioning, and (3) dynamic functioning which may underlie impaired functioning and contribute to vulnerability to psychiatric disorders. Due to their depressive symptomatology, patients may face some difficulties with self-report questionnaires. Therefore, we have restricted the total number of items included in the assessment battery.
Measuring instruments:
T0 (before the start of the intervention):
Interviews:
- SCID by independent interviewer
- Initial psychoanalytic interview by clinician
- Global Assessment Scale (GAS)
Questionnaires:
- BDI (Beck Depression Inventory)
- QIDS (Quick Inventory of Depressive Symptoms; self and independent assessment)
- DEQ (Depressive Experience Questionnaire)
- CTQ (Child Trauma Questionnaire)
- OPD SF
- IIP (Inventory Interpersonal Problems)
- SCL-90-R (Symptom Checklist)
- WAI (Work Ability Index)
- Trauma diary
- Trauma memory narrative
fMRI
- Resting state
- different modalities to measure neuroplasticity by perfusion imaging (cortical thickness, diffusion)
T1 (1 year after start of intervention) Interviews:
- LIFE by independent interviewer
- Global Assessment Scale (GAS)
Questionnaires:
- BDI (Beck Depression Inventory)
- QIDS (Quick Inventory of Depressive Symptoms; self and independent assessment)
- DEQ (Depressive Experience Questionnaire)
- CTQ (Child Trauma Questionnaire)
- OPD SF
- IIP (Inventory Interpersonal Problems)
- SCL-90-R (Symptom Checklist)
- WAI (Work Ability Index)
- Trauma diary
- Trauma memory narrative
fMRI
- Resting state
- different modalities to measure neuroplasticity by perfusion imaging (cortical thickness, diffusion) (ICTRP)

Data di registrazione
12.03.2019 (ICTRP)

Inclusione del primo partecipante
01.10.2019 (ICTRP)

Sponsor secondari
non disponibile

Contatti aggiuntivi
Andju;Tamara Labuhn;Fischmann, andjusara@labuhn.eu; tamara.fischmann@ipu-berlin.de, 0049 69 174629;+49 1723060145, Frankfurter Psychoanalytisches Institut (FPI),International Psychoanalytic University (ICTRP)

ID secondari
U1111-1229-2321, 20-581 (ICTRP)

Risultati-Dati individuali dei partecipanti
No (ICTRP)

Ulteriori informazioni sullo studio
http://drks.de/search/en/trial/DRKS00016872 (ICTRP)