An interventional study of Brief Behavioural Activation and Care as usual in Depression - Major Depressive Disorder, Anxiety and Colon Cancer, sponsored by Region Västmanland. Not yet recruiting at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2024-12-20.
Sponsored by Region Västmanland · Not applicable, Interventional, and Treatment
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.
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:
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's planned enrollment of 400 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Region Västmanland is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Brief Behavioural Activation · Other: Care as usual
Care as usual provided by Västmanland County hospital.
Other: Care as usual
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 provided by Region Västamanland,
Anxiety and Depression Symptoms: Hospital Anxiety and Depression Scale, HADS
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.
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.
Mental well-being
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.
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.
Health-related quality of life (HRQoL )
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.
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.
Behavioral Activation for Depression Scale - Short Form BADS-SF
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.
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.
Perceived self-efficacy
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.
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.
Prognostic markers
Recurrence (3 and 5 years), metastasis (local recurrence and distant metastases), cause of deathe and survival (DFS and OS at 3 and 5 years).
Time frame: Measurement 3 and 5 years after diagnosis and treatment.
Plan to share: Yes — De-identified outcome measure IPD will be shared upon reasonable requests from academic researchers.
Supporting information: Study protocol, Sap
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Region Västmanland