Early Mindfulness Based Cognitive Therapy for Prevention of Psychological Distress in Cancer Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIsala
About this trial
The goal of this clinical trial is to learn if early provision of mindfulness based cognitive therapy can prevent psychological distress in adult patients with cancer one year after diagnosis.
Researchers will compare mindfulness based cognitive therapy to usual care to see if psychological distress is lower in patients that followed mindfulness.
Participants will follow 8 weekly sessions of mindfulness and fill in questionnaires.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with urological cancer or breast cancer
<6 weeks since cancer diagnosis
Planned curative treatment or palliative treatment with life expectation >1 year
Good proficiency in Dutch language
Disqualifiers
Serious psychiatric history or current psychiatric treatment (interfering with study participation): 1) current suicidal ideation, 2) current psychosis or bipolar disorder, 3) psychosis or bipolar disorder in history
Unable to understand study procedure
A priori unable to be available for 8 week MBCT
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness based stress reduction
Behavioral8 weekly sessions of 2.5 hour per session, face-to-face in a group consisting of maximum 15 participants, supervised by a certified mindfulness trainer
Treatment groups
208 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Psychological distress
Anxiety and depression as measured with the Hospital Anxiety and Depression Scale
Time frame
From enrollment to 2 years after diagnosisLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Isala
Lead sponsor
Helen Dowling Institute
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: