Internet-delivered Psycho-oncological Support (ICBT_MAC)

August 19, 2021 updated by: Peter Tonn, Neuropsychiatrischen Zentrums Hamburg-Altona

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Hamburg, Germany, 22769
        • Recruiting
        • Neuropsychiatric Center of Hamburg
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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
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
Time Frame: 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
Start at baseline (t1), Second measurement at t2 estimated 8 weeks later, Followup 6months (t3)
Resilience
Time Frame: 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
Start at baseline (t1), Second measurement at t2 estimated 8 weeks later, Followup 6months (t3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuropsychiatrischen Zentrums Hamburg-Altona

Collaborators

University of Hamburg-Eppendorf

Investigators

  • Principal Investigator: Peter Tonn, MD, Managing director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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