Evaluation of a Male-specific Psychotherapeutic Program for Major Depressive Disorders Compared to Standard Cognitive Behavioral Therapy: a Randomized Controlled Superiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- Changes in the therapeutic alliance quality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age between 25 - 50 years
- •German speaking
- •Current major depression (assessed by SCID-5)
- •Informed consent as documented by signature
排除标准
- •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
- •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
研究组 & 干预措施
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.
干预措施: Male-specific psychotherapeutic program (MSPP) (Behavioral)
cognitive behavioral therapy (CBT)
In this treatment group, depressed men will receive standard cognitive behavioral psychotherapy for depressive disorders (CBT) in a single setting.
干预措施: Cognitive beahvioral therapy (CBT) (Behavioral)
Waitlist
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)
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.
干预措施: Male-specific psychotherapeutic program (MSPP) (Behavioral)
cognitive behavioral therapy (CBT) + testosterone treatment (TT)
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.
干预措施: Cognitive beahvioral therapy (CBT) (Behavioral)
Waitlist + testosterone treatment (TT)
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.
结局指标
主要结局
Changes in the therapeutic alliance quality
时间窗: week 6 / week 24
Self reported working alliance quality with the therapist
Change from baseline observer assessed depressive symptomatology to post treatment
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: baseline / 24 weeks
self-reported depressive symptomatology measured with the Beck Depression Inventory (BDI-II)
Changes in gender role conflict
时间窗: baseline / 24 weeks
Self-reported symptoms of gender role conflict measured with the Gender Role Conflict Scale (GRCS-16)
Achieved remission
时间窗: 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
时间窗: 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.
次要结局
- Suicide Cognitions Scales (SCS-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)
- Generalized Anxiety Disorder (GAD-7)(baseline / week 6 / week 15 / post treatment week 24 / follow up week 36)
- Perceived Stress Scale (PSS-10)(baseline / week 6 / week 15 / post treatment week 24 / follow up week 36)
- Conformity Masculine Norms Inventory (CMNI-30)(baseline / week 6 / week 15 / post treatment week 24 / follow up week 36)
- Skala Suizidales Erleben und Verhalten (SSEV-9)(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)
- International Index of Erectile Function 15 (IIEF-15)(baseline / week 6 / week 15 / post treatment week 24 / follow up week 36)
- Male Role Norms Inventory - Short Form (MRNI-SF-21)(baseline / week 6 / week 15 / post treatment week 24 / follow up week 36)
- Precarious Manhood Beliefs Scale (PMB-4)(baseline / week 6 / week 15 / post treatment week 24 / follow up week 36)
- Agression Questionnaire Buss and Perry (AQ-BP)(baseline / week 6 / post treatment week 24 / follow up week 36)
- Self-stigma of seeking psychological help (SSOSH-10)(baseline / week 6 / post treatment week 24 / follow up week 36)
- Arnett Inventory of Sensation Seeking (AISS-20)(baseline / week 6 / post treatment week 24 / follow up week 36)
- SHAME Questionnaire (SHAME-21)(baseline / week 6 / post treatment week 24 / follow up week 36)
- Loneliness Scale (LS-20)(baseline / week 6 / week 15 / post treatment week 24 / follow up week 36)
- Self-Compassion Scale D (SCS-D 10)(baseline / week 6 / week 15 / post treatment week 24 / follow up week 36)
- Emotion Regulation Questionnaire (ERQ-10)(baseline / week 6 / week 15 / post treatment week 24 / follow up week 36)
- General Belongingness Scale (GBS)(baseline / week 6 / week 15 / post treatment week 24 / follow up week 36)
- CIDI-Traumaliste (CIDI-T-12)(baseline / week 6 / post treatment week 24 / follow up week 36)
- Body Appreciation Scale 2 (BAS-2-10)(baseline / week 6 / post treatment week 24 / follow up week 36)
- Stigma questionnaire (STIG-9)(baseline / week 6 / post treatment week 24 / follow up week 36)
- Need to Belong Scale (NTBS-10)(baseline / week 6 / post treatment week 24 / follow up week 36)
- International Trauma Questionnaire (ITQ-18)(baseline / week 6 / post treatment week 24 / follow up week 36)
- Male Body Attitudes Scale-Revised (MBAS-R-15)(baseline / week 6 / post treatment week 24 / follow up week 36)
- Fragebogens zum Körperbild (FKB-6)(baseline / week 6 / post treatment week 24 / follow up week 36)
- Test of Self-Conscious Affect (TOSCA-16)(baseline / week 6 / post treatment week 24 / follow up week 36)
- Toronto Alexithymia Scale (TAS-20)(baseline / week 6 / post treatment week 24 / follow up week 36)
- Multidimensional Self-Concept Scale (MSCS)(baseline / week 6 / post treatment week 24 / follow up week 36)
研究者
Andreas Walther
Dr. phil.
University of Zurich