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

Sponsor
Region Västmanland
Study ID
NCT06745700
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Brief Behavioural Activation — BEHAVIORAL
    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.
  • Care as usual — OTHER
    Care as usual provided by Region Västamanland,

Study Details

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.

Key Dates

First listed
Dec 20, 2024
Start date
Jan 31, 2025
Status verified
Dec 2024
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Brief Behavioural Activation
    Five-session Brief Behavioral Activation intervention. Sessions 1 - 4 are completed once a week, and session 5 is a booster-session completed four weeks after session 4 and care as usual provided by Region Västmanland.
  • Other: Care as Usual
    Care as usual provided by Västmanland County hospital.

Primary Outcome Measure

Anxiety and Depression Symptoms: Hospital Anxiety and Depression Scale, HADS [ Time Frame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 6 months, 1 and 3 years post-intervention or equivalent for control group. ]

Central Contacts

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