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

NCT05435222 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2025-03-28

No results posted yet for this study

Summary

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

Interventions

BEHAVIORAL

Male-specific psychotherapeutic program (MSPP)

The MSPP for MDD is designed to be used for the acute treatment of depression in men in 18 sessions over a period of 18 weeks. Therapy is delivered weekly with homework bridging every session. Central CBT elements (e.g. behavioral activation, cognitive restructuring) will be retained in MSPP. During implementation of typical CBT techniques, masculine role norms will be considered. One underlying topic will be the potential of multiple masculinities to coexist, being fluid and relational within one man, emphasizing positive aspects of masculinities compatible with psychotherapy for MDD.

BEHAVIORAL

Cognitive beahvioral therapy (CBT)

This intervention consists of 18 sessions of manualized, standard cognitive behavioral therapy for major depression. Therapy is delivered weekly with homework bridging every session.

Sponsors & Collaborators

  • Andreas Walther

    lead OTHER

Principal Investigators

  • Andreas Walther, PhD · University of Zurich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-15
Primary Completion
2025-10-01
Completion
2025-10-31

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05435222 on ClinicalTrials.gov