Skip to main content
Clinical Trials/NCT06745674
NCT06745674
Completed
Not Applicable

Effectiveness of Internet-based Acceptance and Commitment Therapy for Cancer Patients: A Pilot Randomized Controlled Trial Using Mixed Methods

The Hong Kong Polytechnic University1 site in 1 country60 target enrollmentJanuary 1, 2023
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
The Hong Kong Polytechnic University
Enrollment
60
Locations
1
Primary Endpoint
Psychological Distress
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study will focus on supporting cancer patients who often experience emotional challenges like anxiety and depression. It will test a two-week online program called Acceptance and Commitment Therapy (ACT), designed to help people manage difficult emotions and focus on what matters most in their lives.

The program will include short, easy-to-follow sessions covering helpful strategies like accepting distress and staying present in the moment. Participants will be randomly assigned to either join the ACT program or wait for the program while continuing their usual care. The study aims to determine whether the ACT program can reduce psychological distress, anxiety, and depression in cancer patients. The study will use a mixed-methods approach, combining both quantitative data (such as changes in distress, anxiety, and depression) and qualitative insights from participant interviews. This will help us gain a deeper understanding of how the ACT program may support the psychological distress of cancer patients.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
June 1, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • age 18 and above;
  • diagnosed cancer with a clear disease course
  • fluent in Chinese with the ability to read and understand questionnaires independently;
  • ability to operate a smartphone independently;
  • not participating in or intervening in other clinical studies.

Exclusion Criteria

  • younger than 18 years of age
  • unable to use a smartphone
  • have significant cognitive impairment or a serious systemic disease or psychiatric disorder
  • concurrently participating in other clinical studies or undergoing other psychotherapy

Outcomes

Primary Outcomes

Psychological Distress

Time Frame: Baseline, one week post-baseline, and post-intervention (immediately after the 2-week intervention)

Psychological distress is assessed using the Distress Thermometer (DT) (Holland et al., 2013). Scores range from 0 (no distress) to 10 (extreme distress), with higher scores reflecting greater levels of psychological distress.

Feasibility outcomes

Time Frame: Post-intervention (immediately after the 2-week intervention)

Feasibility is evaluated using retention rate and intervention completion rate. Retention rate reflects the percentage of participants who successfully completed all study-related measurements throughout the trial.

Acceptability

Time Frame: Post-intervention (immediately after the 2-week intervention)

Acceptability is evaluated using the Client Satisfaction Questionnaire (CSQ-8) (Larsen et al., 1979). This 8-item measure uses a 4-point Likert scale (1 = low satisfaction to 4 = high satisfaction), with higher scores indicating greater satisfaction with the treatment.

Anxiety and Depression

Time Frame: Baseline, one week post-baseline, and post-intervention (immediately after the 2-week intervention)

Anxiety and depression are measured using the Hospital Anxiety and Depression Scale (HADS) (Zigmond \& Snaith, 1983), a 14-item questionnaire comprising separate subscales for anxiety and depression. Each item is scored on a 4-point Likert scale, and higher scores reflect greater severity of anxiety and depression symptoms.

Study Sites (1)

Loading locations...

Similar Trials