Early Mindfulness Based Cognitive Therapy for Prevention of Psychological Distress in Cancer Patients

NCT07124481 | Not Yet Recruiting

• 1 other identifier: 2306
• Study Type: interventional
• Target: 208
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cancer; Mindfulness Based Cognitive Therapy

Outcome Measures

Primary Outcomes (1)

• Psychological distress

  Anxiety and depression as measured with the Hospital Anxiety and Depression Scale

  From enrollment to 2 years after diagnosis

Study Arms (2)

Intervention

EXPERIMENTAL

mindfulness based stress reduction

Behavioral: Mindfulness based stress reduction

Control

NO INTERVENTION

Interventions

Mindfulness based stress reduction BEHAVIORAL

8 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

Also known as: mindfulness, mindfulness therapy, MBCT

Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Isala: lead
• Helen Dowling Institute: collaborator

MeSH Terms

Conditions

Neoplasms

Interventions

Mindfulness-Based Stress Reduction; Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Marit Mentink, PhD

CONTACT

+31657643188; m.d.c.mentink@isala.nl

Eva Noorda, PhD

CONTACT

evanoorda@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 15, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-08