ClinicalTrials.gov
ClinicalTrials.gov Menu

Internet-delivered Psycho-oncological Support (ICBT_MAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02670200
Recruitment Status : Recruiting
First Posted : February 1, 2016
Last Update Posted : August 27, 2018
Sponsor:
Collaborator:
University of Hamburg
Information provided by (Responsible Party):
Peter Tonn, 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.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: cognitive behavior therapy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: MAC-CBT Used as Internet-delivered Psycho-oncological Support
Actual Study Start Date : April 10, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cancer patient
  • psychological distress
  • informed consent

Exclusion Criteria:

  • no informed consent
  • no cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670200


Contacts
Contact: Peter Tonn, MD +494053307380 tonn@npz-hamburg.de
Contact: Silja C. Reuter, MD +494053307380 reuter@npz-hamburg.de

Locations
Germany
Neuropsychiatric Center of Hamburg Recruiting
Hamburg, Germany, 22769
Contact: Nina Schulze, MoS    +494053307380    schulze@npz-hamburg.de   
Sponsors and Collaborators
Neuropsychiatrischen Zentrums Hamburg-Altona
University of Hamburg
Investigators
Principal Investigator: Peter Tonn, MD Managing Director

Responsible Party: Peter Tonn, Managing director of the Department, Neuropsychiatrischen Zentrums Hamburg-Altona
ClinicalTrials.gov Identifier: NCT02670200     History of Changes
Other Study ID Numbers: NS-2016-001
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No this ist not planned yet.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peter Tonn, Neuropsychiatrischen Zentrums Hamburg-Altona:
psychooncology
mental health support
ICBT
supportive treatment for cancer patients
depression
online-therapy
Psycho-oncological support via internet
internet-delivered cognitive behavior medicine