Major Depressive DisorderMSPP-MDDNCT05435222
Evaluation of a Male-specific Psychotherapeutic Program for Major Depressive Disorders
A study testing Male-specific psychotherapeutic program (MSPP) and Cognitive beahvioral therapy (CBT) in people with Major Depressive Disorder, run by Andreas Walther at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years, men only
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Male-specific psychotherapeutic program (MSPP) and Cognitive beahvioral therapy (CBT)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Mar 2023to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male sex
- Age between 25 - 50 years
- German speaking
- Current major depression (assessed by SCID-5)
- Informed consent as documented by signature
Who cannot join
- 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)
Show all 27Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Ambulatory for Cognitive Behavioral Therapy and Behavioral Medicine of the University of Zurich
Zurich, Canton of Zurich, 8032
Simona Palm, PhD, +41 44 634 52 76, s.palm@psychologie.uzh.ch
Ulrike Ehlert, Professor, +41 44 635 73 50, u.ehlert@psychologie.uzh.ch
About this study
Official title: Evaluation of a Male-specific Psychotherapeutic Program for Major Depressive Disorders Compared to Standard Cognitive Behavioral Therapy: a Randomized Controlled Superiority Trial
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Male-specific psychotherapeutic program (MSPP), Cognitive beahvioral therapy (CBT)
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Male-specific psychotherapeutic program (MSPP)Behavioural
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.
Cognitive beahvioral therapy (CBT)Behavioural
This intervention consists of 18 sessions of manualized, standard cognitive behavioral therapy for major depression. Therapy is delivered weekly with homework bridging every session.
| Study group | Role | What they receive |
|---|---|---|
| male-specific psychotherapeutic program (MSPP) | Experimental | 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. Receives: Behavioral: Male-specific psychotherapeutic program (MSPP) |
| cognitive behavioral therapy (CBT) | Active comparator | In this treatment group, depressed men will receive standard cognitive behavioral psychotherapy for depressive disorders (CBT) in a single setting. Receives: Behavioral: Cognitive beahvioral therapy (CBT) |
| Waitlist | No intervention | The participants in the Waitlist group are required to complete a waiting period of 36 weeks prior receiving the MSPP. As an additional safety measure, participants will be monitored by means of three appointments at week 6, 10 and 14 with a study psychologist. Subsequently, monthly telephone calls at week 18, 22, 26, and 30 are conducted. During these appointments no intervention will occur, while a treatment relationship is to be established so that the patient can describe his specific life circumstances and report possible symptom exacerbations or suicidality. |
| male-specific psychotherapeutic program (MSPP) + testosterone treatment (TT) | Experimental | 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. Receives: Behavioral: Male-specific psychotherapeutic program (MSPP) |
| cognitive behavioral therapy (CBT) + testosterone treatment (TT) | Active comparator | 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. Receives: Behavioral: Cognitive beahvioral therapy (CBT) |
| Waitlist + testosterone treatment (TT) | No intervention | The participants in the Waitlist group are required to complete a waiting period of 36 weeks prior receiving the MSPP. As an additional safety measure, participants will be monitored by means of three appointments at week 6, 10 and 14 with a study psychologist. Subsequently, monthly telephone calls at week 18, 22, 26, and 30 are conducted. During these appointments no intervention will occur, while a treatment relationship is to be established so that the patient can describe his specific life circumstances and report possible symptom exacerbations or suicidality. Further participants receive a standard testosterone replacement therapy consisting of testosterone undecanoate administered via deep intramuscular injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline observer assessed depressive symptomatology to post treatment
Observer assessed depressive symptomatology measured with the Hamilton Depression Rating Scale (HDRS-21)
Measured: baseline / 24 weeks
Changes in the clinical symptomatology from baseline to post treatment
Observer assessed clinical symptomatology measured with the Clinical Global impression Scale (CGI-S/I)
Measured: baseline / 24 weeks
Change from baseline male typical depressive symptomatology to post treatment
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)
Measured: baseline / 24 weeks
Change from baseline self-reported depressive symptomatology to post treatment
self-reported depressive symptomatology measured with the Beck Depression Inventory (BDI-II)
Measured: baseline / 24 weeks
Changes in gender role conflict
Self-reported symptoms of gender role conflict measured with the Gender Role Conflict Scale (GRCS-16)
Measured: baseline / 24 weeks
Drop out
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.
Measured: at follow up week 36
Achieved remission
Proportion of participants, that achieved depressive symptom remission (assessed by structured clinical interview [SCID-5-CV] for DSM-V disorders)
Measured: post treatment week 24
Changes in the therapeutic alliance quality
Self reported working alliance quality with the therapist
Measured: week 6 / week 24
Secondary outcomes (28)
Skala Suizidales Erleben und Verhalten (SSEV-9)
Self-reported suicidal experience and behavior
Measured: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
Suicide Cognitions Scales (SCS-18)
Self-reported attitudes toward suicide
Measured: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
Problematic Pornography Consumption Scale (PPCS-18)
Self-reported pornography use and problematic consumption
Measured: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
Alcohol Use Disorder Test 10 (AUDIT-10)
Self-reported alcohol consumption symptomatology
Measured: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
International Index of Erectile Function 15 (IIEF-15)
Self-reported sexual dysfunction and libido symptomatology
Measured: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
Perceived Stress Scale (PSS-10)
Self-reported subjective stress
Measured: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
Generalized Anxiety Disorder (GAD-7)
Self-reported general anxiety
Measured: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
Conformity Masculine Norms Inventory (CMNI-30)
Self-reported conformity to traditional male role norms
Measured: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
Male Role Norms Inventory - Short Form (MRNI-SF-21)
Self-reported socially learned male role norms
Measured: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
Precarious Manhood Beliefs Scale (PMB-4)
Self-reported precarious manhood beliefs
Measured: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
Loneliness Scale (LS-20)
Self-reported feeling of loneliness and social isolation
Measured: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
Self-Compassion Scale D (SCS-D 10)
Self-reported Positive attitude towards oneself in difficult life situations
Measured: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
Emotion Regulation Questionnaire (ERQ-10)
Self-reported tendency to re-evaluate / suppress emotions
Measured: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
General Belongingness Scale (GBS)
Self-reported achieved belongingness
Measured: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
CIDI-Traumaliste (CIDI-T-12)
Assessment of self-reported traumatic experiences over the life span
Measured: baseline / week 6 / post treatment week 24 / follow up week 36
International Trauma Questionnaire (ITQ-18)
Self-reported core symptoms of post-traumatic stress disorder and complex post-traumatic stress disorder
Measured: baseline / week 6 / post treatment week 24 / follow up week 36
Agression Questionnaire Buss and Perry (AQ-BP)
Self-reported anger and aggression symptomatology
Measured: baseline / week 6 / post treatment week 24 / follow up week 36
Fragebogens zum Körperbild (FKB-6)
Self-reported attitudes towards one's own and an ideal body image
Measured: baseline / week 6 / post treatment week 24 / follow up week 36
Male Body Attitudes Scale-Revised (MBAS-R-15)
Self-reported male-specific body (dis)satisfaction
Measured: baseline / week 6 / post treatment week 24 / follow up week 36
Body Appreciation Scale 2 (BAS-2-10)
Self-reported assessment of a positive body image
Measured: baseline / week 6 / post treatment week 24 / follow up week 36
Stigma questionnaire (STIG-9)
Self-reported experienced stigma for suffering from a mental illness
Measured: baseline / week 6 / post treatment week 24 / follow up week 36
Self-stigma of seeking psychological help (SSOSH-10)
Self-reported experienced stigma of seeking help
Measured: baseline / week 6 / post treatment week 24 / follow up week 36
SHAME Questionnaire (SHAME-21)
Self-reported physical, cognitive and existential shame
Measured: baseline / week 6 / post treatment week 24 / follow up week 36
Test of Self-Conscious Affect (TOSCA-16)
Assessment of susceptibility to guilt, shame, externalization, and unconcern (self-report questionnaire).
Measured: baseline / week 6 / post treatment week 24 / follow up week 36
Toronto Alexithymia Scale (TAS-20)
Self-reported difficulty identifying and describing emotions
Measured: baseline / week 6 / post treatment week 24 / follow up week 36
Multidimensional Self-Concept Scale (MSCS)
Self-reported self-concept (self-worth)
Measured: baseline / week 6 / post treatment week 24 / follow up week 36
Arnett Inventory of Sensation Seeking (AISS-20)
Self-reported seeking of intense experiences including risky behavior
Measured: baseline / week 6 / post treatment week 24 / follow up week 36
Need to Belong Scale (NTBS-10)
Self-reported motivation to be accepted by others and avoidance of rejection by others
Measured: baseline / week 6 / post treatment week 24 / follow up week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start15 Mar 2023
- Primary completion1 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- six-arm randomized controlled superiority trial 2x3 factorial study design Additionally, a healthy control group will be examined, which will undergo only baseline assessments. The study is a six-arm randomized controlled superiority trial. Participants will be stratified by testosterone status (eugonadal / hypogonadal) and then randomized into one of the three groups (MSPP, CBT or Waitlist). The study presents a 2x3 factorial study design. In addition, a separate healthy control group will be examined, which will undergo only baseline assessments.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andreas Walther
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andreas Walther, University of Zurich
- Investigators
- Andreas Walther, PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435222
- Sponsor's protocol ID
- 000-000-001
- Acronym
- MSPP-MDD
- Status last verified
- Mar 2025
- First submitted
- 14 Sep 2020
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41922435Walther 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 depressed eugonadal and hypogonadal men receiving testosterone. Front Psychiatry. 2023 Jun 21;14:1129386. doi: 10.3389/fpsyt.2023.1129386. eCollection 2023.
PubMed 37415687
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Male-specific Psychotherapeutic Program for Major Depressive Disorders Compared to Standard Cognitive Behavioral Therapy: a Randomized Controlled Superiority Trial
- ClinicalTrials.gov ID
- NCT05435222
- Acronym / sponsor ID
- MSPP-MDD / 000-000-001
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Andreas WaltherUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
- Model description
- six-arm randomized controlled superiority trial 2x3 factorial study design Additionally, a healthy control group will be examined, which will undergo only baseline assessments. The study is a six-arm randomized controlled superiority trial. Participants will be stratified by testosterone status (eugonadal / hypogonadal) and then randomized into one of the three groups (MSPP, CBT or Waitlist). The study presents a 2x3 factorial study design. In addition, a separate healthy control group will be examined, which will undergo only baseline assessments.
| Arm | Type | Receives |
|---|---|---|
| male-specific psychotherapeutic program (MSPP) | Experimental | Behavioral: 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) | Active comparator | Behavioral: Cognitive beahvioral therapy (CBT)In this treatment group, depressed men will receive standard cognitive behavioral psychotherapy for depressive disorders (CBT) in a single setting. |
| Waitlist | No intervention | –The participants in the Waitlist group are required to complete a waiting period of 36 weeks prior receiving the MSPP. As an additional safety measure, participants will be monitored by means of three appointments at week 6, 10 and 14 with a study psychologist. Subsequently, monthly telephone calls at week 18, 22, 26, and 30 are conducted. During these appointments no intervention will occur, while a treatment relationship is to be established so that the patient can describe his specific life circumstances and report possible symptom exacerbations or suicidality. |
| male-specific psychotherapeutic program (MSPP) + testosterone treatment (TT) | Experimental | Behavioral: 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. |
| cognitive behavioral therapy (CBT) + testosterone treatment (TT) | Active comparator | Behavioral: 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. |
| Waitlist + testosterone treatment (TT) | No intervention | –The participants in the Waitlist group are required to complete a waiting period of 36 weeks prior receiving the MSPP. As an additional safety measure, participants will be monitored by means of three appointments at week 6, 10 and 14 with a study psychologist. Subsequently, monthly telephone calls at week 18, 22, 26, and 30 are conducted. During these appointments no intervention will occur, while a treatment relationship is to be established so that the patient can describe his specific life circumstances and report possible symptom exacerbations or suicidality. Further participants receive a standard testosterone replacement therapy consisting of testosterone undecanoate administered via deep intramuscular injection. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male sex
- Age between 25 - 50 years
- German speaking
- Current major depression (assessed by SCID-5)
- Informed consent as documented by signature
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | male-specific psychotherapeutic program (MSPP), male-specific psychotherapeutic program (MSPP) + testosterone treatment (TT) |
| 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. | Behavioural | cognitive behavioral therapy (CBT), cognitive behavioral therapy (CBT) + testosterone treatment (TT) |
Primary outcome
Change from baseline observer assessed depressive symptomatology to post treatment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline / 24 weeks
self-reported depressive symptomatology measured with the Beck Depression Inventory (BDI-II)
Changes in gender role conflict
Time frame: baseline / 24 weeks
Self-reported symptoms of gender role conflict measured with the Gender Role Conflict Scale (GRCS-16)
Drop out
Time frame: 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.
Achieved remission
Time frame: post treatment week 24
Proportion of participants, that achieved depressive symptom remission (assessed by structured clinical interview [SCID-5-CV] for DSM-V disorders)
Changes in the therapeutic alliance quality
Time frame: week 6 / week 24
Self reported working alliance quality with the therapist
28 secondary outcomes
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
Emotion Regulation Questionnaire (ERQ-10)
Time frame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
General Belongingness Scale (GBS)
Time frame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
CIDI-Traumaliste (CIDI-T-12)
Time frame: baseline / week 6 / post treatment week 24 / follow up week 36
International Trauma Questionnaire (ITQ-18)
Time frame: baseline / week 6 / post treatment week 24 / follow up week 36
Agression Questionnaire Buss and Perry (AQ-BP)
Time frame: baseline / week 6 / post treatment week 24 / follow up week 36
Fragebogens zum Körperbild (FKB-6)
Time frame: baseline / week 6 / post treatment week 24 / follow up week 36
Male Body Attitudes Scale-Revised (MBAS-R-15)
Time frame: baseline / week 6 / post treatment week 24 / follow up week 36
Body Appreciation Scale 2 (BAS-2-10)
Time frame: baseline / week 6 / post treatment week 24 / follow up week 36
Stigma questionnaire (STIG-9)
Time frame: baseline / week 6 / post treatment week 24 / follow up week 36
Self-stigma of seeking psychological help (SSOSH-10)
Time frame: baseline / week 6 / post treatment week 24 / follow up week 36
SHAME Questionnaire (SHAME-21)
Time frame: baseline / week 6 / post treatment week 24 / follow up week 36
Test of Self-Conscious Affect (TOSCA-16)
Time frame: baseline / week 6 / post treatment week 24 / follow up week 36
Toronto Alexithymia Scale (TAS-20)
Time frame: baseline / week 6 / post treatment week 24 / follow up week 36
Multidimensional Self-Concept Scale (MSCS)
Time frame: baseline / week 6 / post treatment week 24 / follow up week 36
Arnett Inventory of Sensation Seeking (AISS-20)
Time frame: baseline / week 6 / post treatment week 24 / follow up week 36
Need to Belong Scale (NTBS-10)
Time frame: baseline / week 6 / post treatment week 24 / follow up week 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Derived from this study: PubMed 41922435Schneeberger 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.
- Derived from this study: PubMed 37415687Walther 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 depressed eugonadal and hypogonadal men receiving testosterone. Front Psychiatry. 2023 Jun 21;14:1129386. doi: 10.3389/fpsyt.2023.1129386. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andreas Walther, PhD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Male-specific psychotherapeutic program (MSPP) and Cognitive beahvioral therapy (CBT) in people with Major Depressive Disorder, run by Andreas Walther at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andreas Walther, PhD (+41 78 307 18 16, a.walther@psychologie.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline observer assessed depressive symptomatology to post treatment (time frame: baseline / 24 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05435222, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.