NCT05583851 — Investigating Whether Digital Acceptance Commitment Therapy Can Improve Mental Health for Hong Kong Cancer Patients Suffering From Depressive and Anxiety Symptoms. · CancerIndex
Clinical trial · Interventional
Investigating Whether Digital Acceptance Commitment Therapy Can Improve Mental Health for Hong Kong Cancer Patients Suffering From Depressive and Anxiety Symptoms.
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
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.
interventionNames
Device: Acceptance and Commitment Therapy
type
ACTIVE_COMPARATOR
label
Psychoeducational Video Control group
description
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.
interventionNames
Other: Psychoeducation Active Control
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
18 Years
Show eligibility criteria text
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
References
Publications (37)
BACKGROUNDBai 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. PMID 31563072
BACKGROUNDBarnes-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. PMID 11605362
BACKGROUNDChe, Lu, Chen, Chang. Validation of the Chinese Version of the Beck Anxiety Inventory. 台灣醫學. 1006; 447-454.
BACKGROUNDCheung 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. PMID 28807701
BACKGROUNDCillessen 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. PMID 31464026
BACKGROUNDCotter DD. Psychometric evaluation of the Valued Living Questionnaire: Comparing distressed and normative samples. Western Michigan University. 2011.
BACKGROUNDDeng 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.
BACKGROUNDFitzpatrick 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.
Primary outcomes (3)
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
timeFrame
baseline, immediately after treatment, 3 month follow up
description
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).
measure
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
timeFrame
baseline, immediately after treatment, 3 month follow up
description
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).
measure
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
timeFrame
baseline, immediately after treatment, 3 month follow up
description
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).
Secondary outcomes (2)
measure
Acceptability, measured by responses to 4 statements regarding expectations of the intervention at baseline and, immediately after treatment, and 3 month follow up.
timeFrame
baseline, immediately after treatment, 3 month follow up
description
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.
measure
Feasibility, measured by proportion of content completed by immediately after treatment
timeFrame
immediately after treatment
description
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.
BACKGROUNDGillanders 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. PMID 24411117
BACKGROUNDGraham 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. PMID 27176925
BACKGROUNDHayes SC. Buddhism and acceptance and commitment therapy. Cognitive and Behavioral Practice. 2002; 9(1), 58-66.
BACKGROUNDHayes SC. Get out of your mind and into your life: The new acceptance and commitment therapy. New Harbinger Publications. 2005.
BACKGROUNDHayes SC, Strosahl KD, Wilson KG. Acceptance and commitment therapy. Washington, DC: American Psychological Association. 2009.
BACKGROUNDHinz 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. PMID 20030697
BACKGROUNDKim 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. PMID 24605197
BACKGROUNDKioskli K, Scott W, Winkley K, Godfrey E, McCracken LM. Online Acceptance and Commitment Therapy for People with Painful Diabetic Neuropathy in the United Kingdom: A Single-Arm Feasibility Trial. Pain Med. 2020 Nov 1;21(11):2777-2788. doi: 10.1093/pm/pnaa110. PMID 32358608
BACKGROUNDLi H, Wong CL, Jin X, Chen J, Chong YY, Bai Y. Effects of Acceptance and Commitment Therapy on health-related outcomes for patients with advanced cancer: A systematic review. Int J Nurs Stud. 2021 Mar;115:103876. doi: 10.1016/j.ijnurstu.2021.103876. Epub 2021 Jan 12. PMID 33517079
BACKGROUNDLin J, Paganini S, Sander L, Luking M, Ebert DD, Buhrman M, Andersson G, Baumeister H. An Internet-Based Intervention for Chronic Pain. Dtsch Arztebl Int. 2017 Oct 13;114(41):681-688. doi: 10.3238/arztebl.2017.0681. PMID 29082858
BACKGROUNDLuoma JB, Hayes SC, Walser RD. Learning ACT: An acceptance & commitment therapy skills-training manual for therapists. New Harbinger Publications. 2007.
BACKGROUNDMasuda A, Hayes SC, Sackett CF, Twohig MP. Cognitive defusion and self-relevant negative thoughts: examining the impact of a ninety year old technique. Behav Res Ther. 2004 Apr;42(4):477-85. doi: 10.1016/j.brat.2003.10.008. PMID 14998740
BACKGROUNDMen VY, Emery CR, Yip PSF. Characteristics of cancer patients who died by suicide: A quantitative study of 15-year coronial records. Psychooncology. 2021 Jul;30(7):1051-1058. doi: 10.1002/pon.5634. Epub 2021 Mar 2. PMID 33655563
BACKGROUNDMenin J, de Blasio B. New York city mobile services study. Research Brief, Department of Consumer Affairs, New York City. 2015.
BACKGROUNDOst LG. The efficacy of Acceptance and Commitment Therapy: an updated systematic review and meta-analysis. Behav Res Ther. 2014 Oct;61:105-21. doi: 10.1016/j.brat.2014.07.018. Epub 2014 Aug 19. PMID 25193001
BACKGROUNDPitman A, Suleman S, Hyde N, Hodgkiss A. Depression and anxiety in patients with cancer. BMJ. 2018 Apr 25;361:k1415. doi: 10.1136/bmj.k1415. No abstract available. PMID 29695476
BACKGROUNDRodriguez MA, Jia K, Qian MY. White Bear Suppression Inventory: Structure, reliability and validity of the Chinese version. Chinese Journal of Clinical Psychology. 2012.
BACKGROUNDRazzouk R, Shute V. What is design thinking and why is it important?. Review of educational research. 2012; 82(3): 330-348.
BACKGROUNDSimister HD, Tkachuk GA, Shay BL, Vincent N, Pear JJ, Skrabek RQ. Randomized Controlled Trial of Online Acceptance and Commitment Therapy for Fibromyalgia. J Pain. 2018 Jul;19(7):741-753. doi: 10.1016/j.jpain.2018.02.004. Epub 2018 Mar 2. PMID 29481976
BACKGROUNDTatrow K, Montgomery GH. Cognitive behavioral therapy techniques for distress and pain in breast cancer patients: a meta-analysis. J Behav Med. 2006 Feb;29(1):17-27. doi: 10.1007/s10865-005-9036-1. Epub 2006 Jan 7. PMID 16400532
BACKGROUNDTrompetter HR, Bohlmeijer ET, Veehof MM, Schreurs KM. Internet-based guided self-help intervention for chronic pain based on Acceptance and Commitment Therapy: a randomized controlled trial. J Behav Med. 2015 Feb;38(1):66-80. doi: 10.1007/s10865-014-9579-0. Epub 2014 Jun 13. PMID 24923259
BACKGROUNDvan de Graaf DL, Trompetter HR, Smeets T, Mols F. Online Acceptance and Commitment Therapy (ACT) interventions for chronic pain: A systematic literature review. Internet Interv. 2021 Oct 1;26:100465. doi: 10.1016/j.invent.2021.100465. eCollection 2021 Dec. PMID 34660209
BACKGROUNDWang W, Bian Q, Zhao Y, Li X, Wang W, Du J, Zhang G, Zhou Q, Zhao M. Reliability and validity of the Chinese version of the Patient Health Questionnaire (PHQ-9) in the general population. Gen Hosp Psychiatry. 2014 Sep-Oct;36(5):539-44. doi: 10.1016/j.genhosppsych.2014.05.021. Epub 2014 Jun 6. PMID 25023953
BACKGROUNDWegner DM, Zanakos S. Chronic thought suppression. J Pers. 1994 Dec;62(4):616-40. doi: 10.1111/j.1467-6494.1994.tb00311.x. PMID 7861307
BACKGROUNDWei-Chen Z, Yang J, Li X, Hui-Na G, Zhuo-Hong Z. Reliability and validity of the Chinese version of the Cognitive Fusion Questionnaire. Chinese Mental Health Journal. 2014;28(1): 40-44.
BACKGROUNDWhitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19. PMID 26092476
BACKGROUNDYu CL, Fielding R, Chan CL, Tse VK, Choi PH, Lau WH, Choy DT, O SK, Lee AW, Sham JS. Measuring quality of life of Chinese cancer patients: A validation of the Chinese version of the Functional Assessment of Cancer Therapy-General (FACT-G) scale. Cancer. 2000 Apr 1;88(7):1715-27. PMID 10738232
BACKGROUNDYu X, Tam WW, Wong PT, Lam TH, Stewart SM. The Patient Health Questionnaire-9 for measuring depressive symptoms among the general population in Hong Kong. Compr Psychiatry. 2012 Jan;53(1):95-102. doi: 10.1016/j.comppsych.2010.11.002. Epub 2010 Dec 28. PMID 21193179
BACKGROUNDZhao C, Lai L, Zhang L, Cai Z, Ren Z, Shi C, Luo W, Yan Y. The effects of acceptance and commitment therapy on the psychological and physical outcomes among cancer patients: A meta-analysis with trial sequential analysis. J Psychosom Res. 2021 Jan;140:110304. doi: 10.1016/j.jpsychores.2020.110304. Epub 2020 Nov 20. PMID 33248396