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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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)
• Changes in gender role conflict — baseline / 24 weeks
  Self-reported symptoms of gender role conflict measured with the Gender Role Conflict Scale (GRCS-16)
• 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.
• 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)
• Changes in the therapeutic alliance quality — week 6 / week 24
  Self reported working alliance quality with the therapist

Trial sites (1)

Other trials for the same condition