Effectiveness of mobile application-based cognitive-behavioural therapy in women treated for breast cancer: a randomized controlled pilot study in Germany
- Conditions
- C50Malignant neoplasm of breast
- Registration Number
- DRKS00029918
- Lead Sponsor
- Prosoma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 70
Women with a diagnosis of primary cancer of breast (C50)
- Active oncological treatment with the intention-to-treat (survival prognosis > 6 months)
- Aged 18-75 years
- Ability to read and write fluently in German
- Ability to use the app (general suitability to use mobile applications)
- Performance status assessment by using Eastern Cooperative Oncology Group (ECOG) score = 2
- Informed consent to participate in the study and associated documentation
- Existing comorbidities that affect the mental health or quality of life (especially chronic illnesses: neurological, rheumatological, chronic pain, schizophrenia)
- Current psychotherapeutic treatment aimed at depression, anxiety, and distress disorders
- Other (digital or analogue) CBT therapy aimed at depression, anxiety, and distress disorders ongoing or in the two years prior
- Lack of internet access/smartphone
- Alcohol or drug abuse
- Active psychotic symptoms
- Suicidal tendencies
- Impairment of vision which prevents the product from being used as intended
- Severe cognitive impairments
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method