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NCT Number: NCT06745700

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

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.

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Key information

Conditions

Depression - Major Depressive Disorder Anxiety Anxiety Disorders Behavior Behavioral Symptoms Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Depression Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Mental Disorders Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Clinical research and Dept. of Surgery

Västerås, Region Västmanland, 72189, Sweden

Location contact

Fanny Johansen, MD

CONTACT

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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,

Primary outcomes

  1. 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.

    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.

  2. Mental well-being

    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.

    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.

  3. Health-related quality of life (HRQoL )

    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.

    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.

  4. Behavioral Activation for Depression Scale - Short Form BADS-SF

    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.

    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.

  5. Perceived self-efficacy

    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.

    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.

Other outcomes

  1. Prognostic markers

    Time frame: Measurement 3 and 5 years after diagnosis and treatment.

    Recurrence (3 and 5 years), metastasis (local recurrence and distant metastases), cause of deathe and survival (DFS and OS at 3 and 5 years).

Study contacts

Contact information is provided by the study sponsor or research team.

Catarina Tiselius, MD, PhD, Ass. prof.

CONTACT

[email protected]

+46707343826

Johnny Pellas, PhD, psychologist

CONTACT

[email protected]

004621173000

Sponsors and collaborators

Lead sponsor

Region Västmanland

Other

Registry information

Official study title

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

Acronym: BAdepCa

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Dec 20, 2024
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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