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DepressioniACTNCT06111820

Evaluation of Training Curriculum and Service of Improving Access to Community Therapies

A study testing Improving Access to Community Therapies (iACT) in people with Depression and Anxiety, run by Mind Mental Health Hong Kong Limited at 21 sites in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 current study aims to conduct a comprehensive evaluation of a training curriculum designed for teaching low-intensity psychological interventions to bachelor's degree holders, specifically focusing on principles of Acceptance and Commitment Therapy (ACT) and its intervention effectiveness. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Depression, Anxiety, Mental Health Issue
What is being tested?
Improving Access to Community Therapies (iACT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
21 sitesChina
Study dates
22 May 2022to Sep 2024
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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18-65 years old adults with any of the following problem(s):
  • Anxiety problem (including social, generalised, health anxiety, work anxiety)
  • Mild to moderate depression
  • Other emotional challenges including (but not limited to) low self esteem, perfectionism, mild anger issues, interpersonal or relational challenges, low motivation, lack of purpose, numbness.

Who cannot join

  • Adults with the following features/ presentations are not eligible for the PWP programme and should automatically lead to an onward referral:
  • High severity on the depressive score (PHQ9 >= 20)
  • High or imminent risk (according to scores on PHQ9 question no. 9 and information emerging at triage assessment, including indication of plan and action or the lack of protective factor)
  • Individuals with any of the following diagnoses or situations are also excluded:
  • Obsessive-compulsive disorder
  • Post-traumatic stress disorder
Show all 22Show fewer
  • Bipolar disorder
  • Schizophrenia and other psychotic disorders
  • Dissociative disorders
  • Personality disorders
  • Eating disorders
  • Gender dysphoria
  • Paraphilic disorders
  • Anger issues as primary presenting concern (without anxiety or depression)
  • Sleep issues as primary presenting concern (without anxiety or depression)
  • Substance-related disorders
  • History of trauma or abuse that is considered highly relevant to the current presenting problem they are seeking support for
  • Planned changes to psychotropic medication during the period of PWP intervention
  • Currently receiving regular psychological counselling or support from another practitioner.
  • Diagnosis of a learning disability, cognitive impairment or neurodevelopmental condition that would impair their ability to engage with a structured, manualised intervention (e.g. untreated ADHD or moderate-severe brain injury)
  • Clients with unstable or unsafe home environments (e.g. domestic abuse)
  • Clear safeguarding concerns requiring multi-agency support (e.g. concerns about child abuse or neglect)

Trial locations and contacts

21 sites in 1 country.

Jacky Chow contact

+852 9145 2584

jacky.chow@mind.org.hk

Candice Powell contact

+852 3643 0869

candice.powell@mind.org.hk

21 sites in 1 country

China21 sites, 21 recruiting

  • Aberdeen Kai-fong Welfare Association Services Centre

    Hong Kong

    Ivy Chan, +852 2552 0994, ivychan.hm@aka.org.hk

    Recruiting

  • Baptist Oi Kwan Social Service

    Hong Kong

    Man Cheng, +852 3413 1500, cmcheng@bokss.org.hk

    Recruiting

  • Cedar Communications Ltd

    Hong Kong

    Emily Chu, +852 2616 0119, emily.chu@cedarcom.hk

    Recruiting

  • Central Health

    Hong Kong

    Hannah Reidy, +852 2824 0822, hannah.reidy@mind.org.hk

    Recruiting

  • Central Minds

    Hong Kong

    Sharmeen Shroff, +852 2813 6108, shroff@centralminds.hk

    Recruiting

  • Fu Hong Society

    Hong Kong

    Apple Sung, +852 2214 2500, apple.sung@fuhong.org

    Recruiting

  • HKU Lap-Chee College

    Hong Kong

    Pauline Liu, +852 3917 1419, pauline.liu@hku.hk

    Recruiting

  • HKUSPACE PLK Stanley Ho Community College

    Hong Kong

    Timothy Or, +852 3923 7121, timothy.or@hkuspace-plk.hku.hk

    Recruiting

  • Hong Kong Physically Handicapped and Able-Bodied (PHAB) Association

    Hong Kong

    Vicki Tang, +852 2551 4226, vickitang@hkphab.org.hk

    Recruiting

  • KUNST EXA Academy

    Hong Kong

    Carmen Tong, +852 6771 3626, kunst.kaman@gmail.com

    Recruiting

  • LU Institute of Further Education

    Hong Kong

    Eric Tsui, +852 2616 8274, erictsui@ln.edu.hk

    Recruiting

  • Mind Mental Health Hong Kong Limited

    Hong Kong

    Jacky Chow, +852 9145 2584, jacky.chow@mind.org.hk

    Candice Powell, +852 3643 0869, candice.powell@mind.org.hk

    Recruiting

  • MINDSET

    Hong Kong

    Erica Lam, +852 2579 2104, erica.lam@jardines.com

    Recruiting

  • PathFinders Hong Kong

    Hong Kong

    Erica Chen, +852 5621 8239, erica.chen@pathfinders.org.hk

    Recruiting

  • Run HK

    Hong Kong

    Erin Brown, +852 9096 5502, erin@runhk.org

    Virginie Goethals, +852 6110 3391, virginie@runhk.org

    Recruiting

  • Society for Community Organisation (SoCO)

    Hong Kong

    Nga Ki Leung, +852 2729 2209, soco.kikileung@gmail.com

    Recruiting

  • St. John's Cathedral Counselling Service

    Hong Kong

    Elda Chan, +852 2525 7207, elda.chan@sjccs.hk

    Recruiting

  • The Hong Kong Federation of Youth Groups

    Hong Kong

    Sandy Ma, +852 3755 7216, sandy.ma@hkfyg.org.hk

    Recruiting

  • The Mental Health Association of Hong Kong

    Hong Kong

    Jerry Wong, +852 2834 9618, jerrywong@mhahk.org.hk

    Recruiting

  • WYNG Foundation

    Hong Kong

    Amandine Courret, +852 9773 0828, amandine@wyng.hk

    Recruiting

  • Yuen Long Town Hall

    Hong Kong

    Ruth Tong, +852 6097 8461, kys@ylth.org.hk

    Recruiting

Other trials in China

About this study

The current study aims to conduct a comprehensive evaluation of a training curriculum designed for teaching low-intensity psychological interventions to bachelor's degree holders, specifically focusing on principles of Acceptance and Commitment Therapy (ACT) and its intervention effectiveness. This evaluation is divided into two integral parts.

In the first part, the curriculum, which encompasses a 120-hour intensive teaching block followed by a nine-month placement, will be evaluated. To assess the trainees' competencies in applying the principles of ACT, a series of role-play examinations will be administered at various time points, including pre-training, pre-placement, mid-placement, and end-of-placement. Focus groups will be conducted.

Read more

The second part of the evaluation is to examine the outcomes of low-intensity psychological interventions, delivered by the trainees, targeting adult individuals screened with mild to severe symptoms of depression and anxiety. To achieve this, a series of questionnaires will be administered at several stages: pre-intervention, during each session, and at a three-month follow-up. Outcome measures will include the assessment of depressive and anxiety symptom severity, quality of life, functional impairment, therapeutic alliance, and the level of experiential avoidance. Individual exit interviews and focus groups will be conducted.

The aim of the study:

  1. To evaluate the effectiveness of the training program
  2. To evaluate the effectiveness of the low-intensity psychological intervention based on the Acceptance and Commitment Therapy (ACT) principle

Hypotheses:

It is hypothesised that the competency level of the training participants will increase after the intensive training block and the placement. It is also hypothesised that after receiving the low-intensity psychological intervention based on the ACT principle, the depression and anxiety scores, functioning impairment, and experiential avoidance level will reduce, and quality of life and therapeutic relationship will improve.

Read the detailed description

'Training Participants': Participants from the Psychological Wellbeing Practitioners (PWPs) Programme will be invited to participate in the research. The PWPs are bachelors. Degree holders will undergo 120 hours of intensive training block, followed by a 9-month placement to practise the learnt skills. Given therapist competency will be part of the program, this research will request the participants to consent to the use of the data collected in the program.

'Service Participants': Individuals with depression or anxiety symptoms will be sampled in this study. Participants will be recruited from the placement organisations and promotions on social media, web pages, and at mental health centres. The sample size is estimated to be 300 individuals for initial screening for LIACT-guided self-help services.

Research design:

For training evaluation, given the current training programme already consists of a therapist competency assessment to ensure the quality of the training participants. Recorded role-play videos will be rated the ACT therapist competency by trained psychologists at pre-training, post-training block, mid-placement and post-placement. A consent form will be sent to the training participant to authorise the use of data for analysis.

Repeated measures design will be adopted for this study. Individual guided self-help LIACT service, eligible participants will receive 6-8 sessions of guided self-help LIACT over three to four months. Clinical outcomes (depression and anxiety levels) will be measured at every session, it will take around 5 minutes to complete these two routine outcome measures. Other primary and secondary outcome measures, including functioning impairment, quality of life, psychological flexibility, experiential avoidance, absenteeism, and therapeutic alliance will be at 3 time points, namely pre-treatment, post-treatment (at the end of the last session) and 3-month follow-up. Participants will take around 30 minutes to complete the full package of assessments. These outcome variables will be additionally measured after each session to avoid missing data if participants drop out. The recovery rate and reliable improvement rate will also be used as indicators to evaluate the efficacy of LIACT. Focus groups will be conducted on participants who drop out and complete the programme to understand their experience and journey.

Curriculum The LIACT training curriculum is designed by registered clinical psychologists with consultation from local ACT experts from the Association of Contextual and Behavioural Science (Hong Kong Chapter). There are 5 modules in the intensive training block including introduction, professional and ethics issues, application of ACT low-intensity intervention, troubleshooting and preparation for clinical placement. The LIACT protocol is also piloted and revised by clinical psychologists to ensure its adaptability to local situations. After 120- hour intensive training, the training participants will attend a role play exam to ensure their competency to proceed with the 9-month placement. During the 9-month placement, each PWP is expected to see at least 15 direct service beneficiaries to provide LIACT. During this supervision will be provided regularly to ensure the quality of service delivery and risk management. There will be a mid-placement review and final placement review, and the training participants will submit audio recordings for supervisors to rate for their competence.

A focus group will be conducted for the training participants to understand their learning experience.

Treatment Guided self-help LIACT will be provided to eligible participants. For individual guided self-help LIACT service, an intake assessment will be conducted to assess the presenting problem of the participants at pre-treatment to ensure the suitability to receive LIACT service. Participants will be given the LIACT self-help workbook collaboratively with a PWP. Between each session, clients will read through the workbook and complete the exercises suggested in the workbook. In subsequent sessions, PWP will guide clients to overcome the difficulties in performing the LIACT exercises.

Therapists PWPs will be responsible for providing LIACT to the participants. PWPs have completed a 120-hour intensive training and pass the role play examination prior to placement provision. The training was provided by experienced clinical psychologists and counsellors. Moreover, PWPs are under regular supervision by clinical psychologists, experienced counsellors, or social workers with extensive ACT training.

Being tested
Improving Access to Community Therapies (iACT)
Keywords
Psychotherapies, Psychological therapies, Evaluation, Improving access, Community therapy, Community therapies, Low-intensity, Acceptance and Commitment Therapy, ACT
Medical subject headings
Depression, Anxiety Disorders

What participants receive

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

  • Improving Access to Community Therapies (iACT)Behavioural

    Also called Manualised Acceptance and Commitment Therapy (ACT), Low-intensity Acceptance and Commitment Therapy (LIACT)

    The Low-intensity Acceptance and Commitment Therapy (LIACT) protocol is based on the empirically supported Acceptance and Commitment Therapy (ACT), and is designed by registered clinical psychologists with consultation from local ACT experts from the Association of Contextual and Behavioural Science (Hong Kong Chapter). The LIACT protocol is also piloted and revised by clinical psychologists to ensure its adaptability to local situations. For individual guided self-help LIACT service, an intake assessment will be conducted to assess the presenting problem of the participants at pre-treatment to ensure the suitability to receive LIACT service. Participants will be given the LIACT self-help workbook collaboratively with a Psychological Wellbeing Practitioner (PWP). Between each session, clients will read through the workbook and complete the exercises suggested in the workbook. In subsequent sessions, PWP will guide clients to overcome the difficulties in performing the LIACT exercises.

Study groups in NCT06111820
Study groupRoleWhat they receive
iACT service usersExperimentalAll participants enrolled in the programme will participate in the iACT service referring to the aforementioned details.
Receives: Behavioral: Improving Access to Community Therapies (iACT)

What is being measured

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

  1. ACT Fidelity Measure (ACT-FM)

    This measure is intended to be used by clinicians who are experienced in ACT to rate the competencies of their therapists. It can be used to measure fidelity to ACT in a variety of contexts (e.g. as a tool to evaluate your own or another clinician's practice, or as a research tool). The items capture four key areas within ACT: Therapist Stance, Open Response Style, Aware Response Style and Engaged Response Style. Scoring is broken down into two subgroups - ACT Consistency Score and ACT Inconsistency Score.

    Measured: Pre-training, post-training (2nd month), during mid-placement review (6th month), and during end-of-placement (11th month)

  2. Enhancing Assessment of Common Therapeutic Factors (ENACT) scale

    The ENACT scale is a measurement tool used in clinical psychology and psychotherapy research to assess common therapeutic factors in therapeutic interventions. It measures elements such as the therapeutic alliance, empathy, collaboration, goal consensus, and client involvement. The scale consists of self-report items rated on a Likert scale, providing a quantitative assessment of these factors. It helps therapists and researchers understand the therapeutic process, identify areas for improvement, and explore the relationship between common therapeutic factors and treatment outcomes. Score: 18-54, the higher the more competent in general counselling.

    Measured: Pre-training, post-training (2nd month), during mid-placement review (6th month), and during end-of-placement (11th month)

  3. Patient Health Questionnaire-9 (PHQ-9)

    The PHQ-9 questions are based on diagnostic criteria of depression from DSM-IV and ask about the patient's experience in the last 2 weeks. Questions are about the level of interest in doing things, feeling down or depressed, difficulty with sleeping, energy levels, eating habits, self-perception, ability to concentrate, speed of functioning and thoughts of suicide. Score: 0-27, the higher the more depressed.

    Measured: 1) During clients' enrolment 2) before intake interview (week 0) 3) weekly from session 1 to session 6, and 4) before follow-up (week 12).

  4. Generalised Anxiety Disorder Assessment (GAD-7)

    The Generalised Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for screening and severity measuring of generalised anxiety disorder (GAD). Score: 0-21, the higher the more anxious.

    Measured: During clients' enrolment 2) before intake interview (week 0), weekly from session 1 to session 6, and before follow-up (week 12).

  5. The Work and Social Adjustment Scale (WSAS)

    WSAS is a 5-item, self-report measure of impairment in functioning. It assesses the impact of a person's mental health difficulties on their ability to function in terms of work, home management, social leisure, private leisure and personal or family relationships. Score: 0-40, the higher the more severe the impairment.

    Measured: Before intake interview (week 0), after session 6 (week 6), and before follow-up (week 12).

  6. The World Health Organisation - Five Well-Being Index (WHO-5)

    The WHO-5 is a questionnaire that measures current mental well-being (time frame the previous two weeks)." Originally developed to assess both positive and negative well-being, this five question version use only positively phrased questions to avoid symptom-related language. Score: 0-25, the higher the better well-being.

    Measured: Before intake interview (week 0), after session 6 (week 6), and before follow-up (week 12).

Secondary outcomes (4)

  1. Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI:GH)

    WPAI is a 6-item self-report questionnaire used to assess the impact of health conditions on work productivity and daily activities. It consists of a series of questions that inquire about different aspects of work productivity and activity impairment. It assesses absenteeism (time missed from work due to health issues), presenteeism (reduced productivity while at work due to health issues), overall work productivity impairment, and activity impairment in non-work-related activities. Score: 0-20, the higher the more severe. And the higher the number of hours reported, the more occupationally impaired.

    Measured: Before intake interview (week 0), after session 6 (week 6), and before follow-up (week 12).

  2. Brief Revised Working Alliance Inventory (BR-WAI)

    BR-WAI is a 12-item self-report measure of the therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Score: 12-60. The higher the stronger the therapeutic alliance.

    Measured: Before session 1 (week 1), session 4 (week 4) and session 6 (week 6).

  3. Brief Experiential Avoidance Questionnaire (BEAQ)

    The 15-item self-report measure assesses experiential avoidance or the avoidance of uncomfortable or distressing thoughts and emotions. Score: 6-90. The higher the more avoidance.

    Measured: Before intake interview (week 0), after session 6 (week 6), and before follow-up (week 12).

  4. Acceptance and Action Questionnaire II (AAQ-II)

    This 7-item scale is the most widely used measure of psychological flexibility. Score: 7-49, the higher the less psychologically flexible.

    Measured: Before intake interview (week 0), after session 6 (week 6), and before follow-up (week 12).

Timeline

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

  1. First posted1 Nov 2023
  2. Study start22 May 2022
  3. Primary completionSep 2024 (estimated)
  4. Study completionSep 2024 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06111820
Sponsor's protocol ID
MHK/2023/R01-PWP
Acronym
iACT
Status last verified
Oct 2023
First submitted
10 Oct 2023
Last updated
1 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alonso J, Angermeyer MC, Bernert S, Bruffaerts R, Brugha TS, Bryson H, de Girolamo G, Graaf R, Demyttenaere K, Gasquet I, Haro JM, Katz SJ, Kessler RC, Kovess V, Lepine JP, Ormel J, Polidori G, Russo LJ, Vilagut G, Almansa J, Arbabzadeh-Bouchez S, Autonell J, Bernal M, Buist-Bouwman MA, Codony M, Domingo-Salvany A, Ferrer M, Joo SS, Martinez-Alonso M, Matschinger H, Mazzi F, Morgan Z, Morosini P, Palacin C, Romera B, Taub N, Vollebergh WA; ESEMeD/MHEDEA 2000 Investigators, European Study of the Epidemiology of Mental Disorders (ESEMeD) Project. Disability and quality of life impact of mental disorders in Europe: results from the European Study of the Epidemiology of Mental Disorders (ESEMeD) project. Acta Psychiatr Scand Suppl. 2004;(420):38-46. doi: 10.1111/j.1600-0047.2004.00329.x.

    PubMed 15128386

  • Antony, M. M., Bieling, P. J., Cox, B. J., Enns, M. W., & Swinson, R. P. (1998). Psychometric Properties of the 42-Item and 21-Item Versions of the Depression Anxiety Stress Scales in Clinical Groups and a Community Sample. Psychological assessment, 10(2), 176-181.

  • 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

  • Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.

    PubMed 11438246

  • Belanger L, Savard J, Morin CM. Clinical management of insomnia using cognitive therapy. Behav Sleep Med. 2006;4(3):179-198. doi: 10.1207/s15402010bsm0403_4.

    PubMed 16879081

  • Chung KF, Ho FY, Yeung WF. Psychometric Comparison of the Full and Abbreviated Versions of the Dysfunctional Beliefs and Attitudes about Sleep Scale. J Clin Sleep Med. 2016 Jun 15;12(6):821-8. doi: 10.5664/jcsm.5878.

    PubMed 26857054

  • Clark DM. Implementing NICE guidelines for the psychological treatment of depression and anxiety disorders: the IAPT experience. Int Rev Psychiatry. 2011 Aug;23(4):318-27. doi: 10.3109/09540261.2011.606803.

    PubMed 22026487

  • Clark DM, Layard R, Smithies R, Richards DA, Suckling R, Wright B. Improving access to psychological therapy: Initial evaluation of two UK demonstration sites. Behav Res Ther. 2009 Nov;47(11):910-20. doi: 10.1016/j.brat.2009.07.010. Epub 2009 Jul 14.

    PubMed 19647230

  • Cuijpers P, Donker T, van Straten A, Li J, Andersson G. Is guided self-help as effective as face-to-face psychotherapy for depression and anxiety disorders? A systematic review and meta-analysis of comparative outcome studies. Psychol Med. 2010 Dec;40(12):1943-57. doi: 10.1017/S0033291710000772. Epub 2010 Apr 21.

    PubMed 20406528

  • Espie CA, Inglis SJ, Harvey L, Tessier S. Insomniacs' attributions. psychometric properties of the Dysfunctional Beliefs and Attitudes about Sleep Scale and the Sleep Disturbance Questionnaire. J Psychosom Res. 2000 Feb;48(2):141-8. doi: 10.1016/s0022-3999(99)00090-2.

    PubMed 10719130

  • Gyani A, Shafran R, Layard R, Clark DM. Enhancing recovery rates: lessons from year one of IAPT. Behav Res Ther. 2013 Sep;51(9):597-606. doi: 10.1016/j.brat.2013.06.004. Epub 2013 Jul 4.

    PubMed 23872702

  • Haller H, Breilmann P, Schroter M, Dobos G, Cramer H. A systematic review and meta-analysis of acceptance- and mindfulness-based interventions for DSM-5 anxiety disorders. Sci Rep. 2021 Oct 14;11(1):20385. doi: 10.1038/s41598-021-99882-w.

    PubMed 34650179

  • Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

    PubMed 21479777

  • Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, Swinburn P, Busschbach J. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013 Sep;22(7):1717-27. doi: 10.1007/s11136-012-0322-4. Epub 2012 Nov 25.

    PubMed 23184421

  • Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991 Feb;59(1):12-9. doi: 10.1037//0022-006x.59.1.12.

    PubMed 2002127

Questions about this trial

What is this clinical trial studying?

A study testing Improving Access to Community Therapies (iACT) in people with Depression and Anxiety, run by Mind Mental Health Hong Kong Limited at 21 sites in China.

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 4 inclusion and 22 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 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Jacky Chow (+852 9145 2584, jacky.chow@mind.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ACT Fidelity Measure (ACT-FM) (time frame: Pre-training, post-training (2nd month), during mid-placement review (6th month), and during end-of-placement (11th month)). The study lists 6 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 NCT06111820, which also lists 40 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 1 Nov 2023.

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