Psychological distress in the context of physical illness

epos - emotion-based psycho-oncological online self-help

The emotion-based psycho-oncological online self-help program epos aims to improve the psychosocial care of cancer patients after discharge from hospital. In an initial project phase, epos was developed on the basis of psycho-oncological treatment guidelines as well as our own scientific preliminary work in the fields of psycho-oncology, e-mental health, and psychodynamic as well as emotion-based therapy concepts with strong involvement of patients. It is intended to support coping with the mental and physical stress of the disease. At present, the acceptance and effectiveness of epos is being tested in a second project phase as part of a randomized controlled trial.

Inclusion criteria:

  • Age >= 18 years
  • Cancer diagnosis
  • Currently undergoing cancer treatment or early post-treatment care
  • Sufficient knowledge of the German language
  • Access to the Internet and to a terminal device (computer, laptop or tablet)

Exclusion criteria:

  • Lack of ability to understand and/or consent
  • Severe physical impairment (e. g. severe visual impairment)
  • Severe mental comorbidity (e.g. severe depression, suicidal tendencies, psychosis), that prevents participation in the study

 

Study website

TEACH - Efficacy of team-based care for distressed patients in secondary prevention of chronic coronary heart disease: a randomized controlled trial

Team-based care for mentally distressed patients with chronic coronary heart disease.

Patients with coronary artery disease often have increased stress levels and difficulties in following a healthy lifestyle or reducing cardiovascular risk factors (e.g., smoking cessation and engaging in physical activity).

The TEACH study examines whether a one-year treatment by a team consisting of a treatment assistant and a psychosomatic expert improves the quality of life and risk factor control of patients compared to routine treatment.

Inclusion criteria:

  • Diagnosis of coronary heart disease
  • Relevant exposure to depression/anxiety/stress
  • At least one uncontrolled cardiovascular risk factor (e.g. smoking, HbA1c >= 7.0%)

Exclusion criteria:

  • Serious illness or other factors that make participation impossible (e. g. psychosis, dementia, life expectancy < 1 year)

 

Study website

Cumulative hair cortisol before a traffic accident with traumatic brain injury as a predictor for the development and course of trauma-related disorders

Traumatic brain trauma (SHT) occurs in Germany with a frequency of 323 per 100,000 inhabitants annually. Studies have shown a connection between TBI and impaired attention and concentration, psychological symptoms (depressive mood, aggressiveness) as well as trauma-related disorders. It is known that post-trauma disorders are characterized by hypo- or hypercortisolism, which influence the immune parameters and the course of the disease. It is still unknown, however, whether the changed stress hormone level already existed before the trauma or whether it was caused by the traumatic event. The aim of the present study is to investigate whether the stress hormone cortisol in the hair serves as a predictor for the development of trauma-related disorders and a problematic course of the disease prior to a traffic accident with a traumatic brain injury. A sample of N = 192 patients with TBI after a traffic accident and N = 192 healthy control persons are to be examined. For this purpose, a hair segment sample is taken shortly after the traffic accident and after three and six months, and psychological symptoms, concentration and attention are checked. The results obtained from this study would be of great interest for the development of effective preventive measures.

Group 1:

Patients with TBI and trauma-related disorders after a traffic accident N = 192 (excluding drop-out)

Inclusion criteria:

  • Men and women between 18 and 65 years of age
  • with sufficient knowledge of the German language
  • Traumatic brain injury
  • Hair length of at least 3 cm

Exclusion criteria:

  • pregnancy
  • Ingestion of psychotropic or other medication as well as physical illnesses which could have an influence on the parameters to be examined
  • Patients who are not fully legally competent two weeks after their traumatic event
  • Smokers with more than nine cigarettes a day

A control group with traffic accident victims who did not develop psychological symptoms (healthy control group) is to be surveyed as part of the consecutive survey at the Clinic for Trauma Surgery. This healthy control group is necessary because a possible influencing factor e.g. the washing out of the cortisol in the hair must be specified or controlled.

Group 2:

Patients with TBI without trauma after a traffic accident, N = 192 (excl. Drop out) Inclusion and exclusion criteria are identical to the first group. Exception: This group must not have any psychiatric illnesses. The participants in the study group (with trauma-related disorder) are matched to the patients without trauma-related disorders in terms of age and gender. The use of oral contraceptives, pain medication and smoking status are also recorded as control variables.

Glioma patients in outpatient care - optimization of psychosocial care in neuro-oncological patients (GLIOPT)

Patients with brain tumors often suffer from high psychosocial stress and have a great need for support in terms of social-legal counseling, rehabilitation, psychological support and palliative medical aspects. However, they are not always able to indicate this burden and need by means of a questionnaire.

This cluster-randomized multicenter questionnaire is therefore intended to answer the following question: Is the proportion of psychosocially burdened glioma patients receiving psychosocial care higher when the psychosocial burden is determined in a physician interview compared to screening by questionnaires? Working hypothesis: In a survey on the burden, which is conducted directly by treating physicians and in which the physicians talk to the patients, more psychosocially burdened glioma patients are correctly identified and provided with care than in a survey by questionnaire.

This is a cluster-randomized study, therefore primarily clinics (clusters) were included and randomized. Patients of the participating clinics can participate if they meet the following criteria:

  • Age ≥ 18
  • Legal capacity
  • Diagnosis of a brain tumor
  • Informed consent to study participation

Project homepage

Paving the way for men - Gender-specific allocation and concepts for outpatient cancer counseling (WAG-ES!)

This is a cluster-randomised trial investigating the effect of a complex intervention to increase the proportion of male recipients of cancer counselling in outpatient clinics.

German Project homepage

COPS – Comparison of psycho-oncological and physical exercise interventions for health-related quality of life in cancer: a randomized non-inferiority trial

As part of the National Decade against Cancer, the BMBF is funding practice-altering studies on the prevention, diagnosis and treatment of cancer. The aim of the players involved is to prevent new cases of cancer and to further improve the quality of life and chances of cure of cancer patients. COPS is a comparative therapy study under the overall direction of Prof. Dr. Hans-Christoph Friederich, University Hospital Heidelberg, which addresses all cancer patients. The study examines whether exercise therapy is at least as effective as psycho-oncological treatment in terms of improving quality of life. The study is carried out in cooperation with Dr. Betz, Institute for Physical Therapy, Prevention and Rehabilitation and Prof. Simon, Institute for Sports Medicine, Prevention & Rehabilitation. The study starts with a conceptualization phase, which is localized in Heidelberg. A special feature is that patients are actively involved in the research process and can help shape it. In the multi-center comparative therapy study involving 8 cancer centers (including the University Center for Tumor Diseases Mainz), approximately 2,700 cancer patients are to be included who will receive either psycho-oncological treatment or sports therapy over 12 weeks. A follow-up survey will be conducted 3 and 12 months after the end of the therapy.

Key inclusion criteria:

  • confirmed cancer diagnosis with a survival prognosis of at least two years
  • need for psycho-oncological and physical exercise intervention (identified by routine screening)
  • informed consent
  • age between 18 and 80 years

Key exclusion criteria:

  • ECOG status >3
  • conditions precluding the participation in one of the study arms

     

Patients who come to a rare disease center because they suspect they have a rare disease often suffer from complex symptoms. The symptoms are often accompanied or even caused by psychiatric-psychosomatic illnesses. This further complicates the diagnosis.

With the project ZSE-DUO we want to find out whether the situation can be improved by a new form of care. Within the framework of the project, a dual pilot structure will be introduced in eleven centers for rare diseases throughout Germany. This means that, in addition to a specialist for physical complaints, a specialist for psychiatric-psychosomatic diseases will accompany the clarification of complaints from the beginning and on a long-term basis.

German project homepage

For further information, please contact our site staff:

Dr. Mareike Ernst, Telephone number: 06131-17-7649,
 mareike.ernst@unimedizin-mainz.de

or

get in touch with us via our general e-mail address:
 SPE@unimedizin-mainz.de

University Medical Center Mainz
Study Center for Clinical Trials in Mental Disorders
Untere Zahlbacher Str. 8
55131 Mainz