Cytokine-Induced Transcription in Depressed Inpatients Undergoing Psychotherapy

NCT06388486 | Completed

• 1 other identifier: UMCGoettingen9/9/16
• Study Type: observational
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to measure the levels of cytokine-induced transcription factor activation in a cohort of depressed inpatients undergoing psychotherapy. The study aims to answer the following main questions:

• Do psychological traits (i.e.: social inhibition, negative affectivity, ...) affect the activation of immunomodulatory transcription factors (STAT3, NFkB) in depressed patients?
• Are subjects with these psychological traits affected differently by psychotherapeutic intervention? Study subjects are assessed for their psychological and behavioral traits and receive psychotherapeutic care over several weeks during hospital treatment. Peripheral blood mononuclear cells are isolated from the study subjects, and activation of transcription factors is measured by flow cytometry.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Change in depression

  Hospital Depression and Anxiety Scale (HADS). The HADS instrument is a 14-item scale, with seven items relating to anxiety and seven relating to depression item. Each item on qestionnaire is scored from 0-3 resulting in a score between 0 and 21 for either anxiety or depression with higher scores meaning a worse outcome.

  6 weeks

Interventions

Psychotherapy BEHAVIORAL

Subject receive psychotherapy during hospital treatment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Depressed inpatients, admitted for multimodal treatment, including psychotherapy.

You may qualify if:

• Diagnosis of current depression

You may not qualify if:

• inadequate knowledge of the German language
• unable to give informed consent
• severe psychiatric comorbidities, such as drug abuse and psychotic diseases
• deemed critically unstable by their treating physician

Sponsors & Collaborators

• University Medical Center Goettingen: lead

MeSH Terms

Conditions

Depression

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Head of the Molecular Psychocardiology laboratory

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 29, 2024
• Study Start: January 1, 2017
• Primary Completion: March 9, 2022
• Study Completion: January 1, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share