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

Major Depressive Disorder Clinical Trial

— MSPP-MDD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05435222
• Other study ID #: 000-000-001
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: October 31, 2025

Study information

• Verified date: May 2023
• Source: University of Zurich
• Contact: Andreas Walther, PhD
• Phone: +41 78 307 18 16
• Email: a.walther[@]psychologie.uzh.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 244
• Est. completion date: October 31, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	Ambulatory for Cognitive Behavioral Therapy and Behavioral Medicine of the University of Zurich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Andreas Walther

Country where clinical trial is conducted

Switzerland, 

Outcome

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