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

Not Applicable

Recruiting

• Conditions: Major Depressive Disorder
• Interventions: Behavioral: Male-specific psychotherapeutic program (MSPP); Behavioral: Cognitive beahvioral therapy (CBT)

• Registration Number: NCT05435222
• Lead Sponsor: Andreas Walther

Brief 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.

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.

Study Timeline

• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2022-06-22
• Study First Posted: 2022-06-28
• Study Start: 2023-03-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 244

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
male-specific psychotherapeutic program (MSPP)	Male-specific psychotherapeutic program (MSPP)	In this treatment group, eugonadal depressed men will receive the male-specific adjusted psychotherapy for depressive disorders (MSPP) based on cognitive behavioral principles in a single setting.
cognitive behavioral therapy (CBT)	Cognitive beahvioral therapy (CBT)	In this treatment group, depressed men will receive standard cognitive behavioral psychotherapy for depressive disorders (CBT) in a single setting.
cognitive behavioral therapy (CBT) + testosterone treatment (TT)	Cognitive beahvioral therapy (CBT)	In this treatment group, hypogonadal depressed men (blood testosterone ≤ 12.1 nmol/l) will receive standard cognitive behavioral psychotherapy for depressive disorders (CBT) in a single setting. Further participants receive a standard testosterone replacement therapy consisting of testosterone undecanoate administered via deep intramuscular injection.
male-specific psychotherapeutic program (MSPP) + testosterone treatment (TT)	Male-specific psychotherapeutic program (MSPP)	In this treatment group, hypogonadal depressed men will receive the male-specific adjusted psychotherapy for depressive disorders (MSPP) based on cognitive behavioral principles in a single setting. Further participants receive a standard testosterone replacement therapy consisting of testosterone undecanoate administered via deep intramuscular injection.

Primary Outcome Measures

Name	Time	Method
Changes in the therapeutic alliance quality	week 6 / week 24	Self reported working alliance quality with the therapist
Change from baseline observer assessed depressive symptomatology to post treatment	baseline / 24 weeks	Observer assessed depressive symptomatology measured with the Hamilton Depression Rating Scale (HDRS-21)
Changes in the clinical symptomatology from baseline to post treatment	baseline / 24 weeks	Observer assessed clinical symptomatology measured with the Clinical Global impression Scale (CGI-S/I)
Change from baseline male typical depressive symptomatology to post treatment	baseline / 24 weeks	Self-reported male typical depression symptoms including externalizing behavior such as aggression, risk taking, or alcohol consumption measured with the Male Depression Risk Scale (MDRS-22)
Change from baseline self-reported depressive symptomatology to post treatment	baseline / 24 weeks	self-reported depressive symptomatology measured with the Beck Depression Inventory (BDI-II)
Changes in gender role conflict	baseline / 24 weeks	Self-reported symptoms of gender role conflict measured with the Gender Role Conflict Scale (GRCS-16)
Achieved remission	post treatment week 24	Proportion of participants, that achieved depressive symptom remission (assessed by structured clinical interview \[SCID-5-CV\] for DSM-V disorders)
Drop out	at follow up week 36	Acceptability: Proportion of men who withdraw for any reason (dropout) will be recorded and if dropped out participants consent, a dropout interview will be conducted to examine the reasons for dropout.

Secondary Outcome Measures

Name	Time	Method
Suicide Cognitions Scales (SCS-18)	baseline / week 6 / week 15 / post treatment week 24 / follow up week 36	Self-reported attitudes toward suicide
Alcohol Use Disorder Test 10 (AUDIT-10)	baseline / week 6 / week 15 / post treatment week 24 / follow up week 36	Self-reported alcohol consumption symptomatology
Generalized Anxiety Disorder (GAD-7)	baseline / week 6 / week 15 / post treatment week 24 / follow up week 36	Self-reported general anxiety
Perceived Stress Scale (PSS-10)	baseline / week 6 / week 15 / post treatment week 24 / follow up week 36	Self-reported subjective stress
Conformity Masculine Norms Inventory (CMNI-30)	baseline / week 6 / week 15 / post treatment week 24 / follow up week 36	Self-reported conformity to traditional male role norms
Skala Suizidales Erleben und Verhalten (SSEV-9)	baseline / week 6 / week 15 / post treatment week 24 / follow up week 36	Self-reported suicidal experience and behavior
Problematic Pornography Consumption Scale (PPCS-18)	baseline / week 6 / week 15 / post treatment week 24 / follow up week 36	Self-reported pornography use and problematic consumption
International Index of Erectile Function 15 (IIEF-15)	baseline / week 6 / week 15 / post treatment week 24 / follow up week 36	Self-reported sexual dysfunction and libido symptomatology
Male Role Norms Inventory - Short Form (MRNI-SF-21)	baseline / week 6 / week 15 / post treatment week 24 / follow up week 36	Self-reported socially learned male role norms
Precarious Manhood Beliefs Scale (PMB-4)	baseline / week 6 / week 15 / post treatment week 24 / follow up week 36	Self-reported precarious manhood beliefs
Agression Questionnaire Buss and Perry (AQ-BP)	baseline / week 6 / post treatment week 24 / follow up week 36	Self-reported anger and aggression symptomatology
Self-stigma of seeking psychological help (SSOSH-10)	baseline / week 6 / post treatment week 24 / follow up week 36	Self-reported experienced stigma of seeking help
Arnett Inventory of Sensation Seeking (AISS-20)	baseline / week 6 / post treatment week 24 / follow up week 36	Self-reported seeking of intense experiences including risky behavior
SHAME Questionnaire (SHAME-21)	baseline / week 6 / post treatment week 24 / follow up week 36	Self-reported physical, cognitive and existential shame
Loneliness Scale (LS-20)	baseline / week 6 / week 15 / post treatment week 24 / follow up week 36	Self-reported feeling of loneliness and social isolation
Self-Compassion Scale D (SCS-D 10)	baseline / week 6 / week 15 / post treatment week 24 / follow up week 36	Self-reported Positive attitude towards oneself in difficult life situations
Emotion Regulation Questionnaire (ERQ-10)	baseline / week 6 / week 15 / post treatment week 24 / follow up week 36	Self-reported tendency to re-evaluate / suppress emotions
General Belongingness Scale (GBS)	baseline / week 6 / week 15 / post treatment week 24 / follow up week 36	Self-reported achieved belongingness
CIDI-Traumaliste (CIDI-T-12)	baseline / week 6 / post treatment week 24 / follow up week 36	Assessment of self-reported traumatic experiences over the life span
Body Appreciation Scale 2 (BAS-2-10)	baseline / week 6 / post treatment week 24 / follow up week 36	Self-reported assessment of a positive body image
Stigma questionnaire (STIG-9)	baseline / week 6 / post treatment week 24 / follow up week 36	Self-reported experienced stigma for suffering from a mental illness
Need to Belong Scale (NTBS-10)	baseline / week 6 / post treatment week 24 / follow up week 36	Self-reported motivation to be accepted by others and avoidance of rejection by others
International Trauma Questionnaire (ITQ-18)	baseline / week 6 / post treatment week 24 / follow up week 36	Self-reported core symptoms of post-traumatic stress disorder and complex post-traumatic stress disorder
Male Body Attitudes Scale-Revised (MBAS-R-15)	baseline / week 6 / post treatment week 24 / follow up week 36	Self-reported male-specific body (dis)satisfaction
Fragebogens zum Körperbild (FKB-6)	baseline / week 6 / post treatment week 24 / follow up week 36	Self-reported attitudes towards one's own and an ideal body image
Test of Self-Conscious Affect (TOSCA-16)	baseline / week 6 / post treatment week 24 / follow up week 36	Assessment of susceptibility to guilt, shame, externalization, and unconcern (self-report questionnaire).
Toronto Alexithymia Scale (TAS-20)	baseline / week 6 / post treatment week 24 / follow up week 36	Self-reported difficulty identifying and describing emotions
Multidimensional Self-Concept Scale (MSCS)	baseline / week 6 / post treatment week 24 / follow up week 36	Self-reported self-concept (self-worth)

Trial Locations

Locations (1)

Ambulatory for Cognitive Behavioral Therapy and Behavioral Medicine of the University of Zurich; 🇨🇭 Zürich, Switzerland