Impact of Behavioral Activation on Depression and Quality of Life in Patients with Colon Cancer
NCT ID: NCT06745700
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
400 participants
INTERVENTIONAL
2025-01-31
2030-12-31
Brief Summary
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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
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
NONE
Study Groups
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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.
Brief Behavioural Activation
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
Care as usual provided by Region Västamanland,
Care as Usual
Care as usual provided by Västmanland County hospital.
Care as usual
Care as usual provided by Region Västamanland,
Interventions
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Brief Behavioural Activation
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
Care as usual provided by Region Västamanland,
Eligibility Criteria
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Exclusion Criteria
* 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.
ALL
No
Sponsors
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Region Västmanland
OTHER
Responsible Party
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Catarina Tiselius
MD, PhD, Assoc. professor
Locations
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Centre for Clinical research and Dept. of Surgery
Västerås, Region Västmanland, Sweden
Countries
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Central Contacts
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Facility Contacts
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Fanny Johansen, MD
Role: primary
References
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Pellas 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.
Funderburk 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.
Other Identifiers
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LTV-1011976
Identifier Type: -
Identifier Source: org_study_id