Clinical trial NCT05435222: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 244
Sex: MALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline observer assessed depressive symptomatology to post treatment
timeFrame: baseline / 24 weeks
measure: Changes in the clinical symptomatology from baseline to post treatment
timeFrame: baseline / 24 weeks
measure: Change from baseline male typical depressive symptomatology to post treatment
timeFrame: baseline / 24 weeks
measure: Change from baseline self-reported depressive symptomatology to post treatment
timeFrame: baseline / 24 weeks
measure: Changes in gender role conflict
timeFrame: baseline / 24 weeks
measure: Drop out
timeFrame: at follow up week 36
measure: Achieved remission
timeFrame: post treatment week 24
measure: Changes in the therapeutic alliance quality
timeFrame: week 6 / week 24
Secondary outcomes:
measure: Skala Suizidales Erleben und Verhalten (SSEV-9)
timeFrame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
measure: Suicide Cognitions Scales (SCS-18)
timeFrame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
measure: Problematic Pornography Consumption Scale (PPCS-18)
timeFrame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
measure: Alcohol Use Disorder Test 10 (AUDIT-10)
timeFrame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
measure: International Index of Erectile Function 15 (IIEF-15)
timeFrame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
measure: Perceived Stress Scale (PSS-10)
timeFrame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
measure: Conformity Masculine Norms Inventory (CMNI-30)
timeFrame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
measure: Male Role Norms Inventory - Short Form (MRNI-SF-21)
timeFrame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
measure: Precarious Manhood Beliefs Scale (PMB-4)
timeFrame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
measure: Loneliness Scale (LS-20)
timeFrame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
measure: Self-Compassion Scale D (SCS-D 10)
timeFrame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
measure: Emotion Regulation Questionnaire (ERQ-10)
timeFrame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
measure: General Belongingness Scale (GBS)
timeFrame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
measure: CIDI-Traumaliste (CIDI-T-12)
timeFrame: baseline / week 6 / post treatment week 24 / follow up week 36
measure: International Trauma Questionnaire (ITQ-18)
timeFrame: baseline / week 6 / post treatment week 24 / follow up week 36
measure: Agression Questionnaire Buss and Perry (AQ-BP)
timeFrame: baseline / week 6 / post treatment week 24 / follow up week 36
measure: Fragebogens zum Körperbild (FKB-6)
timeFrame: baseline / week 6 / post treatment week 24 / follow up week 36
measure: Male Body Attitudes Scale-Revised (MBAS-R-15)
timeFrame: baseline / week 6 / post treatment week 24 / follow up week 36
measure: Body Appreciation Scale 2 (BAS-2-10)
timeFrame: baseline / week 6 / post treatment week 24 / follow up week 36
measure: Stigma questionnaire (STIG-9)
timeFrame: baseline / week 6 / post treatment week 24 / follow up week 36
measure: Self-stigma of seeking psychological help (SSOSH-10)
timeFrame: baseline / week 6 / post treatment week 24 / follow up week 36
measure: SHAME Questionnaire (SHAME-21)
timeFrame: baseline / week 6 / post treatment week 24 / follow up week 36
measure: Test of Self-Conscious Affect (TOSCA-16)
timeFrame: baseline / week 6 / post treatment week 24 / follow up week 36
measure: Toronto Alexithymia Scale (TAS-20)
timeFrame: baseline / week 6 / post treatment week 24 / follow up week 36
measure: Multidimensional Self-Concept Scale (MSCS)
timeFrame: baseline / week 6 / post treatment week 24 / follow up week 36
measure: Arnett Inventory of Sensation Seeking (AISS-20)
timeFrame: baseline / week 6 / post treatment week 24 / follow up week 36
measure: Need to Belong Scale (NTBS-10)
timeFrame: baseline / week 6 / post treatment week 24 / follow up week 36
Other outcomes:
measure: Body composition
timeFrame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
measure: Blood testosteron
timeFrame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
measure: Hair testosterone
timeFrame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
measure: Grip strength
timeFrame: baseline / week 6 / week 15 / post treatment week 24 / follow up week 36
Locations:
city: Zürich
country: Switzerland
facility: Ambulatory for Cognitive Behavioral Therapy and Behavioral Medicine of the University of Zurich
Study officials:
affiliation: University of Zurich
name: Andreas Walther, PhD
role: PRINCIPAL_INVESTIGATOR
References: