Internet-delivered Psycho-oncological Support
- Conditions
- Cancer
- Registration Number
- NCT02670200
- Lead Sponsor
- Neuropsychiatrischen Zentrums Hamburg-Altona
- Brief Summary
Cancer patients develop a high psychological burden of the underlying disease. To support patients in outpatient phases psychotherapists are not sufficiently available for establish regularly face-to-face-contact. The availability of Internet-based psychotherapeutic support can bridge this gap. This study examines the effectiveness of MAC-CBT® via the Internet (called Incobeth®) in cancer patients.
- Detailed Description
In this study, a randomized trial is conducted in which the online users are allocated into two different care services (MAC-CBT® vs. psycho-educational support program). Participants are cancer patients who have been advised by their treating oncologists, family doctors or psychotherapists on the online support. All patients are randomized, based on the information the referring physician give about type of tumor, treatment status, prognosis and psychosocial factors. Initial will be done an extensive psychometric survey. The MAC-CBT® group receives an intervention program based on ten modules, in which the aspects of Mindfulness, Acceptance and Commitment in detail are included to start a process-oriented self-treatment with regular feedback by the individually assigned psychologists through the internet-portal and email and through live contacts (via video-telephony). The control group will have access to six modules with a psychoeducational support program, which is also constructed according to the MAC principle. Both groups can use crisis modules (in case of pain, psychological crisis, fear of dying) without access restriction. The control group, upon completion of 6 weeks (for each module one week) can switch to active treatment arm. Input and output results are determined using validated survey instruments. Randomisation is done by a physician not involved in the further course of the evaluation.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Cancer patient
- psychological distress
- informed consent
- no informed consent
- no cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Scores of Prime-MD Start at baseline (t1), Second measurement at t2 estimated 8 weeks later, Followup 6months (t3) Recording of change of score PRIME-MD, depression, anxiety and other mental health issues
- Secondary Outcome Measures
Name Time Method Scores of Quality of Life Start at baseline (t1), Second measurement at t2 estimated 8 weeks later, Followup 6months (t3) Measurement of the changes of quality of life after the treatment
Resilience Start at baseline (t1), Second measurement at t2 estimated 8 weeks later, Followup 6months (t3) Reflection of the changes of resilience to test if it is stable or fluid over the treatment period
Trial Locations
- Locations (1)
Neuropsychiatric Center of Hamburg
🇩🇪Hamburg, Germany
Neuropsychiatric Center of Hamburg🇩🇪Hamburg, GermanyNina Schulze, MoSContact+494053307380schulze@npz-hamburg.de