Internet-delivered Psycho-oncological Support

Not Applicable

• Conditions: Cancer
• Interventions: Behavioral: cognitive behavior therapy

• 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.

Study Timeline

• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-02-01
• Study Start: 2018-04-10
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-19
• Last Update Posted: 2021-08-20
• Primary Completion: 2022-04
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Cancer patient
• psychological distress
• informed consent

Exclusion Criteria

• no informed consent
• no cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention arm / verum arm	cognitive behavior therapy	Participants can work on ten modules specialized cognitive behavior treatments to learn and deal with mindfulness, acceptance and commitment. They should learn to handle their emotions, to accept the situation and to get in an active future. The participants can direct contact a psychotherapist via email, Chat or Skype/tokbox. The modules based on Cognitive Behavior Therapy.
non-intervention arm / control group	cognitive behavior therapy	Participants can work on six modules with information und education goals for learning something about their possibilities to become a better mood, better psychovegetative or psychosocial situation as cancer patient. This modules are based on Cognitive Behavior Therapy. The non-intervention arm will only allow contact to the platform, no direct contact to a psychotherapist (in opposite to the intervention arm) is available.

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