Actively Recruiting
Evaluation of a Male-specific Psychotherapeutic Program for Major Depressive Disorders
Led by Andreas Walther · Updated on 2025-03-28
244
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This project aims to evaluate a male-specific psychotherapeutic program (MSPP) for MDD based on cognitive behavioral therapy (CBT). The primary goal is to test the superiority of the MSPP. This will be conducted in two groups of depressed men, namely eudonadal depressed men and hypogonadal depressed men receiving testosterone treatment (TT). In a randomized study design, the MSPP will be compared to a standard CBT and a waitlist control group, resulting in a total of six study groups. Both standardized psychotherapy programs will encompass 18 sessions delivered in a weekly manner, starting at study week 6 and continuing until study week 24. Aligned with the TT-related medical visits of the hypogonadal men, all participants will be followed up with clinical assessments and biosampling at weeks 0, 6, 15, 24, 36. In addition, a separate healthy control group will be examined, which will undergo only baseline assessments.
CONDITIONS
Official Title
Evaluation of a Male-specific Psychotherapeutic Program for Major Depressive Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male sex
- Age between 25 - 50 years
- German speaking
- Current major depression (assessed by SCID-5)
- Informed consent as documented by signature
You will not qualify if you...
- Inability to give informed consent
- Prior hormonal (testosterone) treatment
- Prior mental health disorder
- Current or previous psychopharmacological treatment
- Current or previous psychological treatment for any psychological disorder (except persistent depressive disorder and mild alcohol/substance use disorder)
- Comorbidities of major depression with any other psychological disorder
- Severe physical disorder requiring priority treatment
- Diagnosed prostate cancer
- Prostatic intraepithelial neoplasia (PIN)
- Severe lower urinary tract symptoms
- Untreated diagnosed sleep apnea
- Current treatment with thyroid hormones, finasteride, antiepileptic drugs, anabolic compounds, hypnotic medication more than 2 nights/week, long-acting benzodiazepines, antipsychotic medication, or drugs affecting serum testosterone
- Genetic or hormonal disorders including Klinefelter's syndrome, Cushing's disease, Addison's disease, or Hashimoto Thyroiditis
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ambulatory for Cognitive Behavioral Therapy and Behavioral Medicine of the University of Zurich
Zurich, Canton of Zurich, Switzerland, 8032
Actively Recruiting
Research Team
A
Andreas Walther, PhD
CONTACT
U
Ulrike Ehlert, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
6
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