Clinical trial · Interventional
Impact of Behavioral Activation on Depression and Quality of Life in Patients with Colon Cancer
Impact of Behavioral Activation on Depression, Anxiety, Health-related Quality of Life (HRQoL), Cancer Recurrence and Survival in Patients with Colon Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Depression - Major Depressive Disorder | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brief Behavioural Activation | Behavioral | — | UNRESOLVED |
| Care as usual | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Brief Behavioural Activation
- description
- 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.
- interventionNames
- Behavioral: Brief Behavioural Activation
- Other: Care as usual
- type
- OTHER
- label
- Care as Usual
- description
- Care as usual provided by Västmanland County hospital.
- interventionNames
- Other: Care as usual
Primary outcomes (5)
- measure
- Anxiety and Depression Symptoms: Hospital Anxiety and Depression Scale, HADS
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDPellas J, Renner F, Ji JL, Damberg M. Telephone-based behavioral activation with mental imagery for depression: A pilot randomized clinical trial in isolated older adults during the Covid-19 pandemic. Int J Geriatr Psychiatry. 2022 Jan;37(1):10.1002/gps.5646. doi: 10.1002/gps.5646. Epub 2021 Nov 10. PMID 34729823
- BACKGROUNDFunderburk JS, Pigeon WR, Shepardson RL, Maisto SA. Brief behavioral activation intervention for depressive symptoms: Patient satisfaction, acceptability, engagement, and treatment response. Psychol Serv. 2020 Nov;17(4):443-451. doi: 10.1037/ser0000328. Epub 2019 Feb 4. PMID 30714752