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NOT YET RECRUITING
NCT06745700
NA

Impact of Behavioral Activation on Depression and Quality of Life in Patients with Colon Cancer

Sponsor: Region Västmanland

View on ClinicalTrials.gov

Summary

The purpose of this randomized clinical trial is to study anxiety and depression symptoms at diagnosis in patients with colon cancer. Previous studies have shown that so-called. Behavioural activation as therapy for these symptoms has a positive impact on the patient's well-being, but it has not been studied whether it also has a positive impact on the patient's mental health in cancer, and whether it can have a prognostically beneficial effect on cancer recurrence risk and survival. The investigators will investigate the prevalence of anxiety and depression symptoms as well as quality of life in colon cancer patients at diagnosis and at follow-up using self-estimated validated protocols in a prospective cohort study. Data will be compared with data from a reference population. In the cohort study the investigators will also perform a nested randomized clinical trial of a brief psychological treatment called Behavioural Activation to patients with colon cancer and comorbid anxiety and/or depression. All participants will answer the questionnaires at diagnosis, after1, 2 and 6 months and after 1 and 3 years.

Official title: Impact of Behavioral Activation on Depression, Anxiety, Health-related Quality of Life (HRQoL), Cancer Recurrence and Survival in Patients with Colon Cancer

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2025-01

Completion Date

2030-12-31

Last Updated

2024-12-20

Healthy Volunteers

No

Interventions

BEHAVIORAL

Brief Behavioural Activation

Behavioral: Brief Behavioral Activation. A five-session telephone-based brief behavioral activation treatment. Session 1: Psychoeducation about depression; treatment rationale for Behavioral Activation (BA); rationale and instructions for activity log. Session 2: Discussion of life goals and values; planning of activities aligned with life goals and values for coming week. Session 3-4: Troubleshooting any problems carrying out activities; planning activities aligned with life goals and values for coming week. Session 5: Troubleshooting any problems carrying out activities; reviewing treatment; stressing the importance of continuing to engage in activities aligned. with life goals and values; creating a a maintenance plan. Other group: care as usual.

OTHER

Care as usual

Care as usual provided by Region Västamanland,

Locations (1)

Centre for Clinical research and Dept. of Surgery

Västerås, Region Västmanland, Sweden