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

Cancer Clinical Trial

— Digi-ACT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05583851
• Other study ID #: Project Axolotl
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: October 2022
• Source: Hollo
• Contact: Tun Hoi Duncan Lim, MSc
• Phone: 97872500
• Email: duncan.lim[@]hollo.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Cancer
• Depression
• Depression, Anxiety
• Quality of Life

Intervention

Device:
• Acceptance and Commitment Therapy
Smartphone app guided and manualized version of acceptance and commitment therapy.

Other:
• Psychoeducation Active Control
Set of 11 public seminar videos regarding depression and anxiety. Each are 15 minutes long.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Hollo	OnCare Hong Kong, The University of Hong Kong

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	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
Other	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	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
Other	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	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
Other	Changes in valued living as assessed by the Chinese Valued Living Questionnaire (VLQ) from baseline to immediately after treatment and 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
Other	Accuracy in video journal predicted PHQ-9 scores as assessed by an ai based video journal Within the baseline to 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
Primary	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
Primary	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
Primary	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	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
Secondary	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