Image

Evaluation of a Male-specific Psychotherapeutic Program for Major Depressive Disorders

Evaluation of a Male-specific Psychotherapeutic Program for Major Depressive Disorders

Recruiting
25-50 years
Male
Phase N/A

Powered by AI

Overview

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.

Description

Background: Although women are twice as likely to suffer from major depressive disorder (MDD) than men, there are still over 100 million men affected by this condition worldwide. Unfortunately, men suffering from MDD seek mental health services about 30% less than women, leaving a large portion of men with unresolved mental health needs. This is reflected in 2-fold higher rates of alcohol use disorder and 4-fold higher rates of completed suicide amongst men, while MDD is considered a prime risk factor for both. A case is made for male-typical MDD phenotypes with differing symptom presentation often unrecognized by clinicians. Although cognitive behavioral therapy (CBT) represents an effective treatment for MDD, conformity to traditional masculinity norms based on stoicism, self-reliance, and restrictive emotionality often hinder men from engaging in psychotherapy. Therefore, a need to address this diagnostic and treatment gap emerges, while recent studies have identified a lack of male-specific psychotherapeutic programs (MSPP) that could persuade more men to take on psychotherapy based on a male-tailored nature, focusing on male-specific topics and being introduced in male-typical environments.

Method and study procedures: In total, 144 depressed men aged between 25 and 50 will be recruited. After Screening procedures, included participants are stratified by testosterone status (hypogoadal vs. eugonadal) and randomized to one of the conditions: MSPP, CBT, Waitlist. This results in six intervention groups (MSPP, CBT, Waitlist, MSPP+TT, CBT+TT, Waitlist+TT). Hypogonadal men will receive testosterone treatment administered at the Andrology-Urology Center (Uroviva). MSPP and CBT intervention groups will receive weekly therapy sessions for MDD over 18 weeks. All participants will be invited to a total of five examination appointments (weeks 0, 6, 15, 24, 36) at the psychological institute of the university of Zurich. In addition, a separate healthy control group will be examined, which will undergo only baseline assessments.

Expected results: Compared to the waitlist control groups, the treatment groups are expected to be more effective and efficacious (depression score reduction of ≥50%) at week 24 and at follow-up week 36. The MSPP, compared to CBT, is expected to show higher effectiveness and efficacy for depression symptoms, higher acceptability and a greater reduction of gender role conflict. In addition, it is expected that the initially hypogonadal men will have increased symptom improvement due to TT as compared to the eugonadal men in the parallel groups and that TT receiving men show an adjunct effect of added psychotherapy as compared to men in the waitlist.

Eligibility

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

Study details
    Major Depressive Disorder

NCT05435222

Andreas Walther

27 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.