CancerICBT_MACNCT02670200
Internet-delivered Psycho-oncological Support
A study testing cognitive behavior therapy in people with Cancer, run by Neuropsychiatrischen Zentrums Hamburg-Altona at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- cognitive behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 10 Apr 2018to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer patient
- psychological distress
- informed consent
Who cannot join
- no informed consent
- no cancer
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Neuropsychiatric Center of Hamburg
Hamburg, 22769
Nina Schulze, MoS, +494053307380, schulze@npz-hamburg.de
About this study
Official title: 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.
Read the 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
- Being tested
- cognitive behavior therapy
- Keywords
- psychooncology, mental health support, ICBT, supportive treatment for cancer patients, depression, online-therapy, Psycho-oncological support via internet, internet-delivered cognitive behavior medicine
- Medical subject headings
- Neoplasms, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavior therapyBehavioural
treatment technique to help people to overcome psychological distress and mental diseases
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: cognitive behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores of Prime-MD
Recording of change of score PRIME-MD, depression, anxiety and other mental health issues
Measured: Start at baseline (t1), Second measurement at t2 estimated 8 weeks later, Followup 6months (t3)
Secondary outcomes (2)
Scores of Quality of Life
Measurement of the changes of quality of life after the treatment
Measured: Start at baseline (t1), Second measurement at t2 estimated 8 weeks later, Followup 6months (t3)
Resilience
Reflection of the changes of resilience to test if it is stable or fluid over the treatment period
Measured: Start at baseline (t1), Second measurement at t2 estimated 8 weeks later, Followup 6months (t3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study start10 Apr 2018
- Primary completionApr 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuropsychiatrischen Zentrums Hamburg-Altona
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hamburg-Eppendorf
- Responsible party
- Principal investigator, Peter Tonn, Neuropsychiatrischen Zentrums Hamburg-Altona
- Investigators
- Peter Tonn, MD, Principal investigator, Managing Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670200
- Sponsor's protocol ID
- NS-2016-001
- Acronym
- ICBT_MAC
- Status last verified
- Aug 2021
- First submitted
- 25 Jan 2016
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No this ist not planned yet.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAC-CBT Used as Internet-delivered Psycho-oncological Support
- ClinicalTrials.gov ID
- NCT02670200
- Acronym / sponsor ID
- ICBT_MAC / NS-2016-001
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Neuropsychiatrischen Zentrums Hamburg-AltonaUniversity, hospital or other
- Collaborators
- University of Hamburg-Eppendorf
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 1 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention arm / verum arm | Experimental | Behavioral: cognitive behavior therapyParticipants 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. |
| non-intervention arm / control group | Active comparator | Behavioral: cognitive behavior therapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cancer patient
- psychological distress
- informed consent
Key exclusion criteria (2 listed)
- no informed consent
- no cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive behavior therapytreatment technique to help people to overcome psychological distress and mental diseases | Behavioural | intervention arm / verum arm, non-intervention arm / control group |
Primary outcome
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
2 secondary outcomes
Scores of Quality of Life
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Individual participant dataSharing planned: No. No this ist not planned yet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Tonn, MD principal investigator
Managing Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavior therapy in people with Cancer, run by Neuropsychiatrischen Zentrums Hamburg-Altona at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Tonn, MD (+494053307380, tonn@npz-hamburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores of Prime-MD (time frame: Start at baseline (t1), Second measurement at t2 estimated 8 weeks later, Followup 6months (t3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.