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

NCT05435222 | Recruiting DMC

• 1 other identifier: 000-000-001
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (8)

• Change from baseline observer assessed depressive symptomatology to post treatment

  Observer assessed depressive symptomatology measured with the Hamilton Depression Rating Scale (HDRS-21)

  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)

  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)

  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)

  baseline / 24 weeks

• Changes in gender role conflict

  Self-reported symptoms of gender role conflict measured with the Gender Role Conflict Scale (GRCS-16)

  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.

  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)

  post treatment week 24

• Changes in the therapeutic alliance quality

  Self reported working alliance quality with the therapist

  week 6 / week 24

Secondary Outcomes (28)

• Skala Suizidales Erleben und Verhalten (SSEV-9)

  baseline / week 6 / week 15 / post treatment week 24 / follow up week 36

• Suicide Cognitions Scales (SCS-18)

  baseline / week 6 / week 15 / post treatment week 24 / follow up week 36

• Problematic Pornography Consumption Scale (PPCS-18)

  baseline / week 6 / week 15 / post treatment week 24 / follow up week 36

• Alcohol Use Disorder Test 10 (AUDIT-10)

  baseline / week 6 / week 15 / post treatment week 24 / follow up week 36

• International Index of Erectile Function 15 (IIEF-15)

  baseline / week 6 / week 15 / post treatment week 24 / follow up week 36

Other Outcomes (4)

• Body composition

  baseline / week 6 / week 15 / post treatment week 24 / follow up week 36

• Blood testosteron

  baseline / week 6 / week 15 / post treatment week 24 / follow up week 36

• Hair testosterone

  baseline / week 6 / week 15 / post treatment week 24 / follow up week 36

Study Arms (6)

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.

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.

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.

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.

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.

Interventions

Male-specific psychotherapeutic program (MSPP) BEHAVIORAL

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.

male-specific psychotherapeutic program (MSPP); male-specific psychotherapeutic program (MSPP) + testosterone treatment (TT)

Cognitive beahvioral therapy (CBT) BEHAVIORAL

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

cognitive behavioral therapy (CBT); cognitive behavioral therapy (CBT) + testosterone treatment (TT)

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Andreas Walther: lead

Study Sites (1)

Ambulatory for Cognitive Behavioral Therapy and Behavioral Medicine of the University of Zurich

Zurich, Canton of Zurich, 8032, Switzerland

RECRUITING

Related Publications (1)

• 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 depressed eugonadal and hypogonadal men receiving testosterone. Front Psychiatry. 2023 Jun 21;14:1129386. doi: 10.3389/fpsyt.2023.1129386. eCollection 2023.

  PMID: 37415687 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Andreas Walther, PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Walther, PhD

CONTACT

+41 78 307 18 16; a.walther@psychologie.uzh.ch

Ulrike Ehlert, Professor

CONTACT

+41 44 635 73 50; u.ehlert@psychologie.uzh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. phil.

Model Details: 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.

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: June 28, 2022
• Study Start: March 15, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 31, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)