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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Depression, Anxiety, Quality of Life, Cancer

Intervention / Treatment
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* Device: Acceptance and Commitment Therapy
* Other: Psychoeducation Active Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digi-ACT Intervention group<br>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<br>* Smartphone app guided and manualized version of acceptance and commitment therapy.<br>* Other names: Digital Acceptance and Commitment Therapy;|
| Active Comparator: Psychoeducational Video Control group<br>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<br>* Set of 11 public seminar videos regarding depression and anxiety. Each are 15 minutes long.<br>|

What is the study measuring?
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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 | 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 | 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 | 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. | 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: I expect to be satisfied with the content I received I expect the intervention facilitated emotional awareness I expect to learn something from the intervention 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Acceptance and Commitment Therapy, Psycho-Oncology