Clinical trial NCT02670200: Internet-delivered Psycho-oncological Support
Official title: MAC-CBT Used as Internet-delivered Psycho-oncological Support
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Keywords: psychooncology
mental health support
ICBT
supportive treatment for cancer patients
depression
online-therapy
Psycho-oncological support via internet
internet-delivered cognitive behavior medicine
Lead sponsor: Neuropsychiatrischen Zentrums Hamburg-Altona
Sponsor class: OTHER
Collaborators: name: University of Hamburg-Eppendorf
First posted: 2016-02-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Cancer patient
* psychological distress
* informed consent

Exclusion Criteria:

* no informed consent
* no cancer

Primary outcomes:
measure: Scores of Prime-MD
timeFrame: Start at baseline (t1), Second measurement at t2 estimated 8 weeks later, Followup 6months (t3)
Secondary outcomes:
measure: Scores of Quality of Life
timeFrame: Start at baseline (t1), Second measurement at t2 estimated 8 weeks later, Followup 6months (t3)
measure: Resilience
timeFrame: Start at baseline (t1), Second measurement at t2 estimated 8 weeks later, Followup 6months (t3)
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Neuropsychiatric Center of Hamburg
Study officials:
affiliation: Managing Director
name: Peter Tonn, MD
role: PRINCIPAL_INVESTIGATOR
References: