Internet-delivered Psycho-oncological Support

NCT ID: NCT02670200

Last Updated: 2021-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-10
• Study Completion Date: 2022-12-31

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

cognitive behavior therapy

Intervention Type: BEHAVIORAL

treatment technique to help people to overcome psychological distress and mental diseases

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.

Group Type: ACTIVE_COMPARATOR

cognitive behavior therapy

Intervention Type: BEHAVIORAL

treatment technique to help people to overcome psychological distress and mental diseases

Interventions

cognitive behavior therapy

treatment technique to help people to overcome psychological distress and mental diseases

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Cancer patient
• psychological distress
• informed consent

Exclusion Criteria

• no informed consent
• no cancer

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Hamburg-Eppendorf

OTHER

Sponsor Role: collaborator

Neuropsychiatrischen Zentrums Hamburg-Altona

OTHER

Sponsor Role: lead

Responsible Party

Peter Tonn

Managing director of the Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Tonn, MD

Role: PRINCIPAL_INVESTIGATOR

Managing Director

Locations

Neuropsychiatric Center of Hamburg

Hamburg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Peter Tonn, MD

Role: CONTACT

tonn@npz-hamburg.de

+494053307380

Silja C. Reuter, MD

Role: CONTACT

reuter@npz-hamburg.de

+494053307380

Facility Contacts

Nina Schulze, MoS

Role: primary

schulze@npz-hamburg.de

+494053307380

Other Identifiers

NS-2016-001

Identifier Type: -

Identifier Source: org_study_id