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Clinical Trials/NCT02670200
NCT02670200
Unknown
Not Applicable

MAC-CBT Used as Internet-delivered Psycho-oncological Support

Neuropsychiatrischen Zentrums Hamburg-Altona1 site in 1 country100 target enrollmentApril 10, 2018
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Neuropsychiatrischen Zentrums Hamburg-Altona
Enrollment
100
Locations
1
Primary Endpoint
Scores of Prime-MD
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 10, 2018
End Date
December 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Neuropsychiatrischen Zentrums Hamburg-Altona
Responsible Party
Principal Investigator
Principal Investigator

Peter Tonn

Managing director of the Department

Neuropsychiatrischen Zentrums Hamburg-Altona

Eligibility Criteria

Inclusion Criteria

  • Cancer patient
  • psychological distress
  • informed consent

Exclusion Criteria

  • no informed consent
  • no cancer

Outcomes

Primary Outcomes

Scores of Prime-MD

Time Frame: 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 Outcomes

  • Scores of Quality of Life(Start at baseline (t1), Second measurement at t2 estimated 8 weeks later, Followup 6months (t3))
  • Resilience(Start at baseline (t1), Second measurement at t2 estimated 8 weeks later, Followup 6months (t3))

Study Sites (1)

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