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

Not Applicable

Not yet recruiting

• Conditions: Depression - Major Depressive Disorder; Anxiety; Colon Cancer

• Registration Number: NCT06745700
• Lead Sponsor: Region Västmanland

Brief 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.

Detailed Description

Colon cancer is common. At diagnosis, about 20% have metastatic disease. The prognosis is determined by the stage of the tumour and the degree of spread, but also by the patient's physical health and other diseases. However, it is not known how the patient's mental health are affected and how common anxiety and depression symptoms are at diagnosis. Depression is known to be one of the most common causes of ill health in the world. It also has been shown that patients with depression and cancer also have a poorer survival rate compared to cancer patients without depression However, previous studies have shown that so-called brief 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.

The goal of this randomized study is to increase knowledge about, to detect and treat anxiety and depression symptoms in patients with colon cancer, with so-called brief behavioural activation, which can lead to improved care, and possibly improve the patients' prognosis in the form of reduced risk of cancer recurrence and improved survival.

All participants will continue their care as usual (CAU), and half of the participants will be randomized to receive a five-session telephone-based BA-treatment spread over two months as an add-on to CAU. All participants will answer a questionnaire in the beginning of the study, 4 weeks after diagnosis, after 9 weeks, and after 3-, 6- and 12 months.

The main questions that the trial aims to answer are if the BA-treatment has an effect in the short and long term on:

* Depressive symptoms

* Anxiety symptoms

* Self-rated activation

* Self efficacy

* Mental wellbeing

* Quality of life

* Cancer recurrence and survival

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Study Start: 2025-01
• Primary Completion: 2028-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• All patients diagnosed with colon cancer in Region Västmanland, will be considered for inclusion. Those who meet the inclusion criteria will be offered to participate in the studies after written approval.

Exclusion Criteria

• language difficulties that cause patients to be unable to absorb the treatment
• ongoing alcohol or substance use syndrome
• elevated suicide risk
• ongoing psychotic disorder, severe depression
• antidepressant treatment initiated within the last month
• ongoing or previous manic episode
• cognitive illness/dementia
• ongoing psychological treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anxiety and Depression Symptoms: Hospital Anxiety and Depression Scale, HADS	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.	The HADS consists of 14 questions, of which 7 constitute a depression scale and 7 constitute an anxiety scale. The points from the seven different statements per subscale are added together and can amount to a maximum of 21 points per subscale. Min 0 and maximum 42 points. Higher scores indicate more anxiety and depression symptoms.
Mental well-being	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.	The short version of the Warwick-Edinburgh Mental Well-being Scale, SWEMWBS. The scores from the seven statements are summed up and vary between minimum 7 and maximum 35 points. Higher scores indicate better psychological well-being.
Health-related quality of life (HRQoL )	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.	EuroQol-5 Dimensions-5 Level Scale, EQ-5D-5L (Feng et al., 2021). The self-assessment scale consists of sub-questions; five questions with five different answer options where the score varies between 1-5 points, where higher scores indicate better HRQoL.
Behavioral Activation for Depression Scale - Short Form BADS-SF	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.	Rating scale with two subscales where one scale sums up activation and the other about avoidant behavior. The scale varies between 0-54 points, with higher scores indicating more activation.
Perceived self-efficacy	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.	Swedish translation of The New General Self-Efficacy Scale S- GSE. The total score of the rating scale varies between 10-40 points where higher scores indicate a higher self-perceived self-efficacy.

Trial Locations

Locations (1)

Centre for Clinical research and Dept. of Surgery; 🇸🇪 Västerås, Region Västmanland, Sweden