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

Official title

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

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.

Detailed 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.

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 o
• 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.

Primary outcome measures

• Change from baseline observer assessed depressive symptomatology to post treatment [Time frame: baseline / 24 weeks]
• Changes in the clinical symptomatology from baseline to post treatment [Time frame: baseline / 24 weeks]
• Change from baseline male typical depressive symptomatology to post treatment [Time frame: baseline / 24 weeks]
• Change from baseline self-reported depressive symptomatology to post treatment [Time frame: baseline / 24 weeks]
• Changes in gender role conflict [Time frame: baseline / 24 weeks]
• Drop out [Time frame: at follow up week 36]
• Achieved remission [Time frame: post treatment week 24]
• Changes in the therapeutic alliance quality [Time frame: week 6 / week 24]

Secondary outcome measures (12)

• Skala Suizidales Erleben und Verhalten (SSEV-9) [Time frame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36]
• Suicide Cognitions Scales (SCS-18) [Time frame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36]
• Problematic Pornography Consumption Scale (PPCS-18) [Time frame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36]
• Alcohol Use Disorder Test 10 (AUDIT-10) [Time frame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36]
• International Index of Erectile Function 15 (IIEF-15) [Time frame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36]
• Perceived Stress Scale (PSS-10) [Time frame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36]
• Generalized Anxiety Disorder (GAD-7) [Time frame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36]
• Conformity Masculine Norms Inventory (CMNI-30) [Time frame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36]
• Male Role Norms Inventory - Short Form (MRNI-SF-21) [Time frame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36]
• Precarious Manhood Beliefs Scale (PMB-4) [Time frame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36]
• Loneliness Scale (LS-20) [Time frame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36]
• Self-Compassion Scale D (SCS-D 10) [Time frame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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

\- 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
• 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
• Genetic / hormonal disorders:

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Double blind

Primary purpose

Treatment

Study locations

Switzerland · 1 center

• Ambulatory for Cognitive Behavioral Therapy and Behavioral Medicine of the University of Z — Zurich

Publications

• Schneeberger M, Ehlert U, Walther A. Traditional masculinity ideologies are associated with psychiatric diagnoses in men. Sci Rep. 2026 Apr 1;16(1):15326. doi: 10.1038/s41598-026-45822-5. PMID 41922435
• Walther A, Ehlert U, Schneeberger M, Eggenberger L, Fluckiger C, Komlenac N, Heald A, Rice T, Palm S, Seidler ZE, Ogrodniczuk JS, Oliffe JL, Rice SM, Kealy D, Weber R, Zimmermann D. Evaluation of a male-specific psychotherapeutic program for major depressive disorder compared to cognitive behavioral therapy and waitlist: study protocol for a six-arm randomized clinical superiority trial examining PMID 37415687

Identifiers

NCT: NCT05435222 · 000-000-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗