Internet-delivered Psycho-oncological Support (ICBT_MAC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: cognitive behavior therapy

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Tonn, MD; Phone Number: +494053307380; Email: tonn@npz-hamburg.de
• Study Contact Backup: Name: Silja C. Reuter, MD; Phone Number: +494053307380; Email: reuter@npz-hamburg.de

Study Locations

• Germany
  • Hamburg, Germany, 22769
    • Recruiting
    • Neuropsychiatric Center of Hamburg
    • Contact: Nina Schulze, MoS; Phone Number: +494053307380; Email: schulze@npz-hamburg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Cancer patient
• psychological distress
• informed consent

Exclusion Criteria:

• no informed consent
• no cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention arm / verum arm; 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.	Behavioral: cognitive behavior therapy; treatment technique to help people to overcome psychological distress and mental diseases
Active Comparator: non-intervention arm / control group; 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.	Behavioral: cognitive behavior therapy; treatment technique to help people to overcome psychological distress and mental diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores of Prime-MD	Recording of change of score PRIME-MD, depression, anxiety and other mental health issues	Start at baseline (t1), Second measurement at t2 estimated 8 weeks later, Followup 6months (t3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores of Quality of Life	Measurement of the changes of quality of life after the treatment	Start at baseline (t1), Second measurement at t2 estimated 8 weeks later, Followup 6months (t3)
Resilience	Reflection of the changes of resilience to test if it is stable or fluid over the treatment period	Start at baseline (t1), Second measurement at t2 estimated 8 weeks later, Followup 6months (t3)

Collaborators and Investigators

• Sponsor: Neuropsychiatrischen Zentrums Hamburg-Altona
• Collaborators: University of Hamburg-Eppendorf
• Investigators: Principal Investigator: Peter Tonn, MD, Managing Director

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2018
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: January 25, 2016
• First Submitted That Met QC Criteria: January 27, 2016
• First Posted (Estimate): February 1, 2016

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: depression; ICBT; psychooncology; mental health support; supportive treatment for cancer patients; online-therapy; Psycho-oncological support via internet; internet-delivered cognitive behavior medicine
• Other Study ID Numbers: NS-2016-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No this ist not planned yet.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No