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

NCT06745700 | Not Yet Recruiting

• 1 other identifier: LTV-1011976
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression - Major Depressive Disorder; Anxiety; Colon Cancer

Keywords

depression; anxiety; health related quality of life; colon cancer

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  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.

Other Outcomes (1)

• Prognostic markers

  Measurement 3 and 5 years after diagnosis and treatment.

Study Arms (2)

Brief Behavioural Activation

EXPERIMENTAL

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

OTHER

Care as usual provided by Västmanland County hospital.

Other: Care as usual

Interventions

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.

Brief Behavioural Activation

Care as usual OTHER

Care as usual provided by Region Västamanland,

Brief Behavioural Activation; Care as Usual

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Västmanland: lead

Study Sites (1)

Centre for Clinical research and Dept. of Surgery

Västerås, Region Västmanland, 72189, Sweden

Location

Related Publications (2)

• 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.

  PMID: 34729823 BACKGROUND

• 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.

  PMID: 30714752 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Colonic Neoplasms; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Behavioral Symptoms; Behavior

Central Study Contacts

Catarina Tiselius, MD, PhD, Ass. prof.

CONTACT

+46707343826; catarina.tiselius@regionvastmanland.se

Johnny Pellas, PhD, psychologist

CONTACT

004621173000; johnny.pellas@regionvastmanland.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Assoc. professor

Model Details: 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.

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 20, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Study protocol and statistical analysis plan to be shared/published before data collection has ended.
• Access Criteria: Data will be shared upon reasonable requests assessed by the investigators.

Locations

SE (1)