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Internet-delivered Psycho-oncological Support

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02670200
Acronym
ICBT_MAC
Enrollment
100
Registered
2016-02-01
Start date
2018-04-10
Completion date
2022-12-31
Last updated
2021-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

BEHAVIORALcognitive behavior therapy

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

Sponsors

University of Hamburg-Eppendorf
CollaboratorOTHER
Neuropsychiatrischen Zentrums Hamburg-Altona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Cancer patient * psychological distress * informed consent

Exclusion criteria

* no informed consent * no cancer

Design outcomes

Primary

MeasureTime frameDescription
Scores of Prime-MDStart 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

MeasureTime frameDescription
Scores of Quality of LifeStart 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
ResilienceStart 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

Countries

Germany

Contacts

Primary ContactPeter Tonn, MD
tonn@npz-hamburg.de+494053307380
Backup ContactSilja C. Reuter, MD
reuter@npz-hamburg.de+494053307380

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026