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Depression, AnxietyDigi-ACTNCT05583851

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

A study testing Acceptance and Commitment Therapy in people with Depression, Anxiety and Quality of Life, run by Hollo.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression, Anxiety, Quality of Life, Cancer
What is being tested?
Acceptance and Commitment Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
1 Nov 2022to 1 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Tun Hoi Duncan Lim, MSc contact

97872500 ext. 852

duncan.lim@hollo.hk

Cameron Van Breda, BS contact

64035861 ext. 852

cameron.vanbreda@hollo.hk

About this study

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

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?
Read more

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.

Read the 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.

Being tested
Acceptance and Commitment Therapy, Psychoeducation Active Control
Keywords
Telemedicine, Acceptance and Commitment Therapy, Psycho-Oncology
Medical subject headings
Depression, Anxiety Disorders, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acceptance and Commitment TherapyDevice

    Also called Digi-ACT, Digital Acceptance and Commitment Therapy

    Smartphone app guided and manualized version of acceptance and commitment therapy.

  • Psychoeducation Active ControlOther

    Set of 11 public seminar videos regarding depression and anxiety. Each are 15 minutes long.

Study groups in NCT05583851
Study groupRoleWhat they receive
Digi-ACT Intervention groupExperimental22 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.
Receives: Device: Acceptance and Commitment Therapy
Psychoeducational Video Control groupActive comparator22 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.
Receives: Other: Psychoeducation Active Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: baseline, immediately after treatment, 3 month follow up

  2. 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).

    Measured: baseline, immediately after treatment, 3 month follow up

  3. 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).

    Measured: baseline, immediately after treatment, 3 month follow up

Secondary outcomes (2)

  1. 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:

    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.

    Measured: baseline, immediately after treatment, 3 month follow up

  2. 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.

    Measured: immediately after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2022
  2. Study start1 Nov 2022 (estimated)
  3. Primary completion1 May 2023 (estimated)
  4. Study completion1 Nov 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05583851
Sponsor's protocol ID
Project Axolotl
Acronym
Digi-ACT
Status last verified
Oct 2022
First submitted
8 Oct 2022
Last updated
19 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bai Z, Luo S, Zhang L, Wu S, Chi I. Acceptance and Commitment Therapy (ACT) to reduce depression: A systematic review and meta-analysis. J Affect Disord. 2020 Jan 1;260:728-737. doi: 10.1016/j.jad.2019.09.040. Epub 2019 Sep 10.

    PubMed 31563072

  • Barnes-Holmes Y, Hayes SC, Barnes-Holmes D, Roche B. Relational frame theory: a post-Skinnerian account of human language and cognition. Adv Child Dev Behav. 2001;28:101-38. doi: 10.1016/s0065-2407(02)80063-5. No abstract available.

    PubMed 11605362

  • Che, Lu, Chen, Chang. Validation of the Chinese Version of the Beck Anxiety Inventory. 台灣醫學. 1006; 447-454.

  • Cheung G, Douwes G, Sundram F. Late-Life Suicide in Terminal Cancer: A Rational Act or Underdiagnosed Depression? J Pain Symptom Manage. 2017 Dec;54(6):835-842. doi: 10.1016/j.jpainsymman.2017.05.004. Epub 2017 Aug 12.

    PubMed 28807701

  • Cillessen L, Johannsen M, Speckens AEM, Zachariae R. Mindfulness-based interventions for psychological and physical health outcomes in cancer patients and survivors: A systematic review and meta-analysis of randomized controlled trials. Psychooncology. 2019 Dec;28(12):2257-2269. doi: 10.1002/pon.5214. Epub 2019 Sep 11.

    PubMed 31464026

  • Cotter DD. Psychometric evaluation of the Valued Living Questionnaire: Comparing distressed and normative samples. Western Michigan University. 2011.

  • Deng Y, Li S, Tang, Zhu L, Ryan R, Brown K. Psychometric properties of the Chinese translation of the mindful attention awareness scale (MAAS). Mindfulness. 2012; 3(1), 10-14.

  • Fitzpatrick KK, Darcy A, Vierhile M. Delivering Cognitive Behavior Therapy to Young Adults With Symptoms of Depression and Anxiety Using a Fully Automated Conversational Agent (Woebot): A Randomized Controlled Trial. JMIR Ment Health. 2017 Jun 6;4(2):e19. doi: 10.2196/mental.7785.

    PubMed 28588005

  • Gillanders DT, Bolderston H, Bond FW, Dempster M, Flaxman PE, Campbell L, Kerr S, Tansey L, Noel P, Ferenbach C, Masley S, Roach L, Lloyd J, May L, Clarke S, Remington B. The development and initial validation of the cognitive fusion questionnaire. Behav Ther. 2014 Jan;45(1):83-101. doi: 10.1016/j.beth.2013.09.001. Epub 2013 Sep 18.

    PubMed 24411117

  • Graham CD, Gouick J, Krahe C, Gillanders D. A systematic review of the use of Acceptance and Commitment Therapy (ACT) in chronic disease and long-term conditions. Clin Psychol Rev. 2016 Jun;46:46-58. doi: 10.1016/j.cpr.2016.04.009. Epub 2016 Apr 20.

    PubMed 27176925

  • Hayes SC. Buddhism and acceptance and commitment therapy. Cognitive and Behavioral Practice. 2002; 9(1), 58-66.

  • Hayes SC. Get out of your mind and into your life: The new acceptance and commitment therapy. New Harbinger Publications. 2005.

  • Hayes SC, Strosahl KD, Wilson KG. Acceptance and commitment therapy. Washington, DC: American Psychological Association. 2009.

  • Hinz A, Krauss O, Hauss JP, Hockel M, Kortmann RD, Stolzenburg JU, Schwarz R. Anxiety and depression in cancer patients compared with the general population. Eur J Cancer Care (Engl). 2010 Jul;19(4):522-9. doi: 10.1111/j.1365-2354.2009.01088.x. Epub 2009 Dec 17.

    PubMed 20030697

  • Kim J, Shin W. How to do random allocation (randomization). Clin Orthop Surg. 2014 Mar;6(1):103-9. doi: 10.4055/cios.2014.6.1.103. Epub 2014 Feb 14.

    PubMed 24605197

Questions about this trial

What is this clinical trial studying?

A study testing Acceptance and Commitment Therapy in people with Depression, Anxiety and Quality of Life, run by Hollo.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tun Hoi Duncan Lim, MSc (97872500 ext. 852, duncan.lim@hollo.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05583851, which also lists 37 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.

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