Investigating Whether Digital Acceptance Commitment Therapy Can Improve Mental Health for Hong Kong Cancer Patients Suffering From Depressive and Anxiety Symptoms. (Digi-ACT)

October 17, 2022 updated by: Duncan Lim, Hollo

Digital Acceptance and Commitment Therapy (Digi-ACT): A Randomized Controlled Trial Pilot Assessing the Efficacy and Feasibility of Software-based Self-managed Intervention Targeting Subclinical Depression and Anxiety in Curative Cancer Patients Within Hong Kong

The goal of this clinical trial is to validate the use of digital Acceptance and Commitment Therapy (Digi-ACT) in Hong Kong curative cancer patients with depressive and anxiety symptoms. The main questions it aims to answer are:

  • Can Digi-ACT reduce depressive or anxiety symptoms?
  • Can Digi-ACT improved health-related quality of life?
  • Is Digi-ACT an acceptable and feasible intervention for users?
  • What are the factors that influence the success of Digi-ACT?
  • Can the video journals used in Digi-ACT predict depressive symptoms?

Intervention group participants will install the Digi-ACT mobile application and undergo a 3-4 week long intervention. They will have to fill out questionnaires at baseline, immediately after the intervention, and at three month follow up to measure depression and anxiety symptoms, health-related quality of life, acceptability of the intervention, and other process outcomes related to the intervention itself.

Researchers will compare the outcomes with a group of participants that undergo a 3-4 week long period where they navigate a similar mobile platform that gives bi-daily psychoeducational videos that also fill out the same clinical questionnaires at baseline, post-intervention, and at three month follow up.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with cancer experience increased rates and severity of depression and anxiety symptoms. This could be due to difficulty dealing with the diagnostic process, treatment side effects, limited social opportunities, physical symptoms, and other cancer-related complications. Acceptance and Commitment Therapy (ACT) has proven to be effective in treating these symptoms for cancer patients. Compared to other evidence based therapies, such as second wave cognitive behavioral therapy (CBT), ACT has shown to have larger effect sizes and success in treating this population. One possible explanation could be due to the theoretical and practical approaches of ACT over traditional CBT. Traditional CBT aims to identify illogical thought patterns that are biased or distorted and try to change them, while ACT makes no attempt at changing these thought patterns and simply teaches the participant to accept and experience these thoughts, emotions, and sensations. For cancer patients, feelings of depression when faced with their own mortality, are unavoidable and could be invalidating if told they are "illogical" or "distorted". Therefore, ACT may have the advantage here in recognizing the severity of the cancer journey and providing an alternative way that does not try to change their experiences.

Furthermore, Hong Kong has a persisting mental health treatment gap due to insufficient mental health practitioners. Oftentimes, only moderate to severe cases of common mental disorders are addressed, thereby leaving milder cases untreated. A possible solution to such under-treatment is digital Health, which requires no additional practitioners and has shown promising results in past studies.

Therefore, we aim to test the efficacy, acceptability, and feasibility of a digitized version (mobile application) of ACT for cancer patients in Hong Kong.

We aim to answer several key questions with the current randomized controlled trial (RCT):

  • Can Digi-ACT reduce depressive and anxiety symptoms from baseline to post-treatment and will this reduction be sustained at three month follow up?
  • Can Digi-ACT improve health related quality of life from baseline to post-treatment and will this reduction be sustained at three month follow up?
  • Is Digi-ACT perceived as an acceptable intervention prior to use? How about after use?
  • Can different ACT process measures moderate the relationship between treatment and clinical outcomes?

Research assistants from Hollo will collaborate with Queen Mary Hospital's Oncological unit and Hong Kong Private Clinic: "Oncare" to recruit 50 Cancer patients for the pilot trial within the inclusion criteria. Participants will be screened at baseline for measures of depression and anxiety. Those that score mild or moderate will be invited to participate in the study. Upon providing informed consent, participants will be instructed to download the Hollo Digi-ACT mobile application.

Participants will be randomly allocated to either intervention or active control. Over 4 weeks, participants in the intervention group will be administered the digitized ACT on their mobile device while those in the active control will receive various educational mental health videos over the 4 weeks. After the completion of the intervention, participants will fill out the same clinical indexes and then a final time 3 months later.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 and above
  • PHQ-9 score of 5 to 14
  • BAI score of 8 to 25
  • Fluent in Cantonese or Mandarin
  • Diagnosed with stage 0 to 3 cancer
  • Received surgery as primary treatment at least four months ago

Exclusion Criteria:

  • Diagnosed with metastatic cancer (stage 4)
  • Language/intellectual difficulties
  • Prior diagnoses of other psychiatric conditions other than unipolar depression or anxiety

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digi-ACT Intervention group
22 day long interactive mobile app intervention with daily activities. The intervention will include 5 total modules: psychoeducation on depression/anxiety and the cancer journey; acceptance; cognitive fusion; mindfulness; and committed valued living. There will be different games and reward components for the Through out the course of the intervention, participants will also do video journals to reflect on the different modules and activities they do.
Device: Acceptance and Commitment Therapy
Smartphone app guided and manualized version of acceptance and commitment therapy.
Other Names:
  • Digi-ACT
  • Digital Acceptance and Commitment Therapy
Active Comparator: Psychoeducational Video Control group
22 day long mobile app where participants will be given a 15 minute long psychoeducational clip from a publicly available online seminar (from the Hong Kong College of Psychiatrists) on a bi-daily basis. Through out the course of the intervention, participants will also do video journals to reflect on the content of the different video clips.
Other: Psychoeducation Active Control
Set of 11 public seminar videos regarding depression and anxiety. Each are 15 minutes long.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Depressive Symptoms severity as assessed by the 9 item Chinese Patient Health Questionnaire (PHQ-) from baseline to immediately after treatment and 3 month follow up
Time Frame: baseline, immediately after treatment, 3 month follow up
The Chinese PHQ9 is a validated, self-report instrument that assesses depressive symptoms in the past 2 weeks. Possible scores range from 0 (no signs of depressive symptoms) to 27 (severe depressive symptoms).
baseline, immediately after treatment, 3 month follow up
Changes in Anxiety Symptoms severity as assessed by the Chinese Beck Anxiety Inventory (BAI) from baseline to immediately after treatment and 3 month follow up
Time Frame: baseline, immediately after treatment, 3 month follow up
The 21 item Chinese (BAI) is a validated, self-report instrument that assesses anxiety symptoms in the past 2 weeks. Possible scores range from 0 (no signs of anxiety symptoms) to 63 (severe anxiety symptoms).
baseline, immediately after treatment, 3 month follow up
Changes in Quality of Life as assessed by the Chinese Functional Assessment of Cancer Therapy (FACT-G) from baseline to immediately after treatment and 3 month follow up
Time Frame: baseline, immediately after treatment, 3 month follow up
The 27 item Chinese FACT-G is a validated, self-report instrument that assesses health related quality of life in the past week. Possible scores range from 0 (poor quality of life) to 108 (strong quality of life).
baseline, immediately after treatment, 3 month follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability, measured by responses to 4 statements regarding expectations of the intervention at baseline and, immediately after treatment, and 3 month follow up.
Time Frame: baseline, immediately after treatment, 3 month follow up

Acceptability, measured by responses to 4 statements regarding expectations of the intervention at baseline and, post-treatment, and 3 month follow up.

The 4 item acceptability measure involve four statements that participants have to rate on a 1 (strongly agree) to 5 (strongly disagree). Statements presented at baseline are as follows:

  1. I expect to be satisfied with the content I received
  2. I expect the intervention facilitated emotional awareness
  3. I expect to learn something from the intervention
  4. I expect for what I learned to be relevant to my everyday life

The four statements presented at post-treatment and 3 month follow up will be presented in past tense.

Minimum score of 4 indicates strong acceptability and the maximum score of 20 indicates lack of acceptability.
baseline, immediately after treatment, 3 month follow up
Feasibility, measured by proportion of content completed by immediately after treatment
Time Frame: immediately after treatment
For those in the intervention group, the digi-ACT content will include 5 modules. Therefore, feasibility for the intervention group will be calculated as the proportion of modules completed, with a score of 0 indicating no modules finished and a score of 1 indicating all modules completed. Similarly, for those in the control video group, there will be 11 videos and feasibility will be calculated as the proportion of these 11 videos viewed with the same minimum and maximum scores.
immediately after treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Acceptance, as assessed by the Chinese White Bear Thought Suppression Inventory (WBSI) from baseline to immediately after treatment and 3 months follow up
Time Frame: baseline, immediately after treatment, 3 month follow up
The 15 item Chinese WBSI measures the degree of thought suppression an individual presents. The inverse score from this measure could be interpreted as a measure of acceptance. Possible scores range from 15 (strong acceptance) to 75 (weak acceptance).
baseline, immediately after treatment, 3 month follow up
Changes in degree of Mindfulness as assessed by the Chinese Mindfulness Attention and Awareness Scale (CMAAS) from baseline to immediately after treatment and 3 month follow up
Time Frame: baseline, immediately after treatment, 3 month follow up
The 15 item CMAAS is a validated, self-report instrument that assesses mindfulness. Total score is calculated as an average of the 15 items that are rated on a 1-6 likert scale. Therefore, the average minimum score starts at 1 (lower levels of mindfulness) and goes up to a maximum score of 6 (high levels of dispositional mindfulness.
baseline, immediately after treatment, 3 month follow up
Changes in cognitive fusion as assessed by the 9 item Chinese Cognitive Fusion Questionnaire (CFQ-9) from baseline to immediately after treatment and 3 month follow up
Time Frame: baseline, immediately after treatment, 3 month follow up
The Chinese CFQ-9 is a validated, self-report instrument that assesses cognitive fusion. Possible scores range from 7 (low levels of cognitive fusion) to 63 (high levels of cognitive fusion)
baseline, immediately after treatment, 3 month follow up
Changes in valued living as assessed by the Chinese Valued Living Questionnaire (VLQ) from baseline to immediately after treatment and 3 month follow up
Time Frame: baseline, immediately after treatment, 3 month follow up
The 10 item Chinese (VLQ) is a validated, self-report instrument that assesses the degree of valued living across 10 different domains. The maximum score of 100 indicates strong and alignment with values whereas a score of 0 would indicate weak alignment and weight placed on their 10 values.
baseline, immediately after treatment, 3 month follow up
Accuracy in video journal predicted PHQ-9 scores as assessed by an ai based video journal Within the baseline to immediately after treatment.
Time Frame: Between baseline and immediately after treatment
A novel video journal measuring facial action units, pitch, and speech content will be used to predict a binary output on whether users present with depression or not. Participants, throughout the intervention or control video viewings, will have to shoot 2 minute videos to react and reflect on the contents of the intervention and videos.
Between baseline and immediately after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hollo

Collaborators

The University of Hong Kong
OnCare Hong Kong

Investigators

  • Principal Investigator: Wendy Wing-lok Chan, MBBS, LKS Faculty of Medicine, HKU
  • Principal Investigator: Kevin Ka Ming Wong, MBBS, OnCare Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

October 8, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (Actual)

October 18, 2022

Study Record Updates

Last Update Posted (Actual)

October 19, 2022

Last Update Submitted That Met QC Criteria

October 17, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Project Axolotl

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe