Internet-delivered Psycho-oncological Support

NCT02670200 | Unknown

• 1 other identifier: NS-2016-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

psychooncology; mental health support; ICBT; supportive treatment for cancer patients; depression; online-therapy; Psycho-oncological support via internet; internet-delivered cognitive behavior medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Scores of Quality of Life

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

• Resilience

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

Study Arms (2)

intervention arm / verum arm

EXPERIMENTAL

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

non-intervention arm / control group

ACTIVE COMPARATOR

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

Interventions

cognitive behavior therapy BEHAVIORAL

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

intervention arm / verum arm; non-intervention arm / control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer patient
• psychological distress
• informed consent

You may not qualify if:

• no informed consent
• no cancer

Sponsors & Collaborators

• Neuropsychiatrischen Zentrums Hamburg-Altona: lead
• University of Hamburg-Eppendorf: collaborator

Study Sites (1)

Neuropsychiatric Center of Hamburg

Hamburg, 22769, Germany

RECRUITING

MeSH Terms

Conditions

Neoplasms; Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Peter Tonn, MD

  Managing Director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Tonn, MD

CONTACT

+494053307380; tonn@npz-hamburg.de

Silja C. Reuter, MD

CONTACT

+494053307380; reuter@npz-hamburg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Managing director of the Department

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: February 1, 2016
• Study Start: April 10, 2018
• Primary Completion: April 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)