Major Depressive Disorder
Conditions
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.
Interventions
BEHAVIORALMale-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.
BEHAVIORALCognitive 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.
Sponsors
Andreas Walther
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
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.
Eligibility
Sex/Gender
MALE
Age
25 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| SHAME Questionnaire (SHAME-21) | baseline / week 6 / post treatment week 24 / follow up week 36 | Self-reported physical, cognitive and existential shame |
| 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) |
| 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 |
| 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 |
| Agression Questionnaire Buss and Perry (AQ-BP) | baseline / week 6 / post treatment week 24 / follow up week 36 | Self-reported anger and aggression symptomatology |
| 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 |
| Suicide Cognitions Scales (SCS-18) | baseline / week 6 / week 15 / post treatment week 24 / follow up week 36 | Self-reported attitudes toward suicide |
| 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 |
| 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 |
| 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 |
| Perceived Stress Scale (PSS-10) | baseline / week 6 / week 15 / post treatment week 24 / follow up week 36 | Self-reported subjective stress |
| Generalized Anxiety Disorder (GAD-7) | baseline / week 6 / week 15 / post treatment week 24 / follow up week 36 | Self-reported general anxiety |
Other
| Measure | Time frame | Description |
|---|---|---|
| Body composition | baseline / week 6 / week 15 / post treatment week 24 / follow up week 36 | Body composition is determined by using bioelectrical impedance analysis (BIA) |
| Grip strength | baseline / week 6 / week 15 / post treatment week 24 / follow up week 36 | Grip strength will be assessed with a basic hydraulic hand dynamometer at each study visit |
| Hair testosterone | baseline / week 6 / week 15 / post treatment week 24 / follow up week 36 | Hair samples are collected at each study visit to assess hair testosterone |
| Blood testosteron | baseline / week 6 / week 15 / post treatment week 24 / follow up week 36 | Blood samples are collected at each study visit to assess blood testosterone |
Countries
Switzerland
Contacts
Primary ContactAndreas Walther, PhD
Backup ContactUlrike Ehlert, Professor
Outcome results
None listed