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Taking people in SwitzerlandNo phase

Tests a men-focused talk therapy program for depression in men

Compares a men-focused therapy program with standard cognitive behavioral therapy in depressed men.

Plain-language title generated from the registry record
Registry title: Evaluation of a Male-specific Psychotherapeutic Program for Major Depressive Disorders

Key facts

Where
Zurich, SwitzerlandSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 25 and 50 years old?

Source: NCT05435222, who can take part

Where in Switzerland

  • Ambulatory for Cognitive Behavioral Therapy and Behavioral Medicine of the University of ZurichZurich, SwitzerlandTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Andreas Walther
Trial code
NCT05435222
Record updated
28 March 2025
Original description
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.Read full original descriptionShow less

Evaluation of a Male-specific Psychotherapeutic Program for Major Depressive Disorders Compared to Standard Cognitive Behavioral Therapy: a Randomized Controlled Superiority Trial

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.

Inclusion: Male sex; Age between 25 - 50 years; German speaking; Current major depression (assessed by SCID-5); Informed consent as documented by signature.

Exclusion: Prior hormonal (testosterone) treatment; Prior mental health disorder; Current or previous psychopharmacological treatment; Current or previous psychological treatment for any psychological disorder; Exception for persistent depressive disorder (Dysthymia) and alcohol/substance use disorder of mild degree (SCID-5, 1 - 3 criteria met); Comorbidities of major depression with any other psychological disorder; Severe physical disorder that requires priority treatment; Any of the following physical conditions, particularly relevant in regard to testosterone treatment:; Diagnosed prostate cancer; Prostatic intraepithelial neoplasia (PIN); Severe lower urinary tract symptoms; Erythrocytosis Sleep apnea, diagnosed but untreated; Genetic / hormonal disorders:; Klinefelter's syndrome; Cushing's disease; Addison's disease; Hashimoto Thyroiditis; Current treatment with:; Thyroid hormones; Finasteride; Antiepileptic drugs; Anabolic compounds; Hypnotic medication more than 2 nights/week for the treatment of insomnia; Long-acting benzodiazepines; Antipsychotic medication; Drugs that affect serum testosterone; Inability to give informed consent.

ClinicalTrials.gov NCT05435222