Evaluation of a male-specific psychotherapeutic program for depression

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

This study is testing a new therapy program designed specifically for men with depression to see if it works better than standard therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 244 (estimated)
• Ages: 25 Years to 50 Years
• Sex: Male
• Sponsor: University of Zurich (Academic / other)
• Locations: 1 site (Zurich, Canton of Zurich)
• Trial ID: NCT05435222 on ClinicalTrials.gov

What this trial studies

This project evaluates a male-specific psychotherapeutic program (MSPP) designed for men suffering from major depressive disorder (MDD). The study involves 144 depressed men aged 25 to 50, who will be randomized into three groups: those receiving the MSPP, standard cognitive behavioral therapy (CBT), or placed on a waitlist. The program consists of 18 weekly sessions, and participants will undergo clinical assessments and biosampling at various intervals. The aim is to determine if the MSPP is more effective than standard CBT in treating MDD in men, particularly considering their unique psychological needs.

Who should consider this trial

Good fit: Ideal candidates are German-speaking men aged 25 to 50 currently experiencing major depression.

Not a fit: Patients with prior hormonal treatment, severe physical disorders, or other significant psychological disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could provide a tailored therapeutic approach that encourages more men to seek and engage in effective treatment for depression.

How similar studies have performed: While traditional CBT has been widely studied, the male-specific approach of this program is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Male sex
2. Age between 25 - 50 years
3. German speaking
4. Current major depression (assessed by SCID-5)
5. Informed consent as documented by signature

Exclusion Criteria:

1. Inability to give informed consent
2. Prior hormonal (testosterone) treatment
3. Prior mental health disorder
4. Current or previous psychopharmacological treatment
5. 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)
6. Comorbidities of major depression with any other psychological disorder
7. Severe physical disorder that requires priority treatment
8. 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
9. 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
10. Genetic / hormonal disorders:

    * Klinefelter's syndrome
    * Cushing's disease
    * Addison's disease
    * Hashimoto Thyroiditis

Where this trial is running

Zurich, Canton of Zurich

• Ambulatory for Cognitive Behavioral Therapy and Behavioral Medicine of the University of Zurich — Zurich, Canton of Zurich, Switzerland (Recruiting)

Study contacts

• Principal investigator: Andreas Walther, PhD — University of Zurich
• Study coordinator: Andreas Walther, PhD

Conditions Major Depressive Disorder