Clinical trial NCT06111820: Evaluation of Training Curriculum and Service of Improving Access to Community Therapies
Official title: Evaluation of Training Curriculum and Service of Improving Access to Community Therapies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Mental Health Issue
Stress
Distress, Emotional
Keywords: Psychotherapies
Psychological therapies
Evaluation
Improving access
Community therapy
Community therapies
Low-intensity
Acceptance and Commitment Therapy
ACT
Lead sponsor: Mind Mental Health Hong Kong Limited
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
First posted: 2023-11-01
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

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.

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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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
* 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)

Primary outcomes:
measure: ACT Fidelity Measure (ACT-FM)
timeFrame: Pre-training, post-training (2nd month), during mid-placement review (6th month), and during end-of-placement (11th month)
measure: Enhancing Assessment of Common Therapeutic Factors (ENACT) scale
timeFrame: Pre-training, post-training (2nd month), during mid-placement review (6th month), and during end-of-placement (11th month)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 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).
measure: Generalised Anxiety Disorder Assessment (GAD-7)
timeFrame: During clients' enrolment 2) before intake interview (week 0), weekly from session 1 to session 6, and before follow-up (week 12).
measure: The Work and Social Adjustment Scale (WSAS)
timeFrame: Before intake interview (week 0), after session 6 (week 6), and before follow-up (week 12).
measure: The World Health Organisation - Five Well-Being Index (WHO-5)
timeFrame: Before intake interview (week 0), after session 6 (week 6), and before follow-up (week 12).
Secondary outcomes:
measure: Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI:GH)
timeFrame: Before intake interview (week 0), after session 6 (week 6), and before follow-up (week 12).
measure: Brief Revised Working Alliance Inventory (BR-WAI)
timeFrame: Before session 1 (week 1), session 4 (week 4) and session 6 (week 6).
measure: Brief Experiential Avoidance Questionnaire (BEAQ)
timeFrame: Before intake interview (week 0), after session 6 (week 6), and before follow-up (week 12).
measure: Acceptance and Action Questionnaire II (AAQ-II)
timeFrame: Before intake interview (week 0), after session 6 (week 6), and before follow-up (week 12).
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Aberdeen Kai-fong Welfare Association Services Centre
city: Hong Kong
country: China
facility: Baptist Oi Kwan Social Service
city: Hong Kong
country: China
facility: Cedar Communications Ltd
city: Hong Kong
country: China
facility: Central Health
city: Hong Kong
country: China
facility: Central Minds
city: Hong Kong
country: China
facility: Fu Hong Society
city: Hong Kong
country: China
facility: HKU Lap-Chee College
city: Hong Kong
country: China
facility: HKUSPACE PLK Stanley Ho Community College
city: Hong Kong
country: China
facility: Hong Kong Physically Handicapped and Able-Bodied (PHAB) Association
city: Hong Kong
country: China
facility: KUNST EXA Academy
city: Hong Kong
country: China
facility: LU Institute of Further Education
city: Hong Kong
country: China
facility: Mind Mental Health Hong Kong Limited
city: Hong Kong
country: China
facility: MINDSET
city: Hong Kong
country: China
facility: PathFinders Hong Kong
city: Hong Kong
country: China
facility: Run HK
city: Hong Kong
country: China
facility: Society for Community Organisation (SoCO)
city: Hong Kong
country: China
facility: St. John's Cathedral Counselling Service
city: Hong Kong
country: China
facility: The Hong Kong Federation of Youth Groups
city: Hong Kong
country: China
facility: The Mental Health Association of Hong Kong
city: Hong Kong
country: China
facility: WYNG Foundation
city: Hong Kong
country: China
facility: Yuen Long Town Hall
Study officials:
affiliation: Mind Mental Health Hong Kong Limited
name: Candice LYM Powell
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese University of Hong Kong
name: Patrick WL Leung
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593.
citation: Kyllönen, H. M., Muotka, J., Puolakanaho, A., Astikainen, P., Keinonen, K., & Lappalainen, R. (2018). A brief acceptance and commitment therapy intervention for depression: A randomized controlled trial with 3-year follow-up for the intervention group. Journal of contextual behavioral science, 10, 55-63.
citation: Kroenke, K., & Spitzer, R. L. (2002). The PHQ-9: A New Depression Diagnostic and Severity Measure. Psychiatric annals, 32(9), 509-515. doi:10.3928/0048-5713-20020901-06
citation: Lam LC, Wong CS, Wang MJ, Chan WC, Chen EY, Ng RM, Hung SF, Cheung EF, Sham PC, Chiu HF, Lam M, Chang WC, Lee EH, Chiang TP, Lau JT, van Os J, Lewis G, Bebbington P. Prevalence, psychosocial correlates and service utilization of depressive and anxiety disorders in Hong Kong: the Hong Kong Mental Morbidity Survey (HKMMS). Soc Psychiatry Psychiatr Epidemiol. 2015 Sep;50(9):1379-88. doi: 10.1007/s00127-015-1014-5. Epub 2015 Feb 8.
citation: Lim D, Sanderson K, Andrews G. Lost productivity among full-time workers with mental disorders. J Ment Health Policy Econ. 2000 Sep 1;3(3):139-146. doi: 10.1002/mhp.93.
citation: Lovibond PF, Rapee RM. The representation of feared outcomes. Behav Res Ther. 1993 Jul;31(6):595-608. doi: 10.1016/0005-7967(93)90111-7.
citation: Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28(6):487-95. doi: 10.1016/0005-7967(90)90135-6.
citation: Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.
citation: Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
citation: School of Health and Related Research (ScHARR), University of Sheffield. Clinical Guidelines for the Management of Anxiety: Management of Anxiety (Panic Disorder, with or without Agoraphobia, and Generalised Anxiety Disorder) in Adults in Primary, Secondary and Community Care [Internet]. London: National Collaborating Centre for Primary Care (UK); 2004 Dec. Available from http://www.ncbi.nlm.nih.gov/books/NBK45834/
citation: National Institute for Health and Clinical Excellence [NICE]. (2009). Depression: treatment and management of depression in adults, including adults with a chronic physical health problem: NICE.
citation: National Institute for Health and Care Excellence [NICE]. (2011, 05 25). Retrieved 06 15, 2022, from Common mental health problems: identification and pathways to care: https://www.nice.org.uk/guidance/cg123/chapter/Recommendations
citation: Ng SS, Lo AW, Leung TK, Chan FS, Wong AT, Lam RW, Tsang DK. Translation and validation of the Chinese version of the short Warwick-Edinburgh Mental Well-being Scale for patients with mental illness in Hong Kong. East Asian Arch Psychiatry. 2014 Mar;24(1):3-9.
citation: Richards DA, Suckling R. Improving access to psychological therapies: phase IV prospective cohort study. Br J Clin Psychol. 2009 Nov;48(Pt 4):377-96. doi: 10.1348/014466509X405178. Epub 2009 Feb 9.
citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
citation: Stewart-Brown S, Tennant A, Tennant R, Platt S, Parkinson J, Weich S. Internal construct validity of the Warwick-Edinburgh Mental Well-being Scale (WEMWBS): a Rasch analysis using data from the Scottish Health Education Population Survey. Health Qual Life Outcomes. 2009 Feb 19;7:15. doi: 10.1186/1477-7525-7-15.
citation: Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.
citation: Wang K, Shi HS, Geng FL, Zou LQ, Tan SP, Wang Y, Neumann DL, Shum DH, Chan RC. Cross-cultural validation of the Depression Anxiety Stress Scale-21 in China. Psychol Assess. 2016 May;28(5):e88-e100. doi: 10.1037/pas0000207. Epub 2015 Nov 30.
citation: Wang 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.
citation: White, J. (2000). Treating anxiety and stress : a group psycho-educational approach using brief CBT. Chichester ; New York: Wiley.
citation: Whiteford HA, Degenhardt L, Rehm J, Baxter AJ, Ferrari AJ, Erskine HE, Charlson FJ, Norman RE, Flaxman AD, Johns N, Burstein R, Murray CJ, Vos T. Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010. Lancet. 2013 Nov 9;382(9904):1575-86. doi: 10.1016/S0140-6736(13)61611-6. Epub 2013 Aug 29.
citation: Williams M, Honan C, Skromanis S, Sanderson B, Matthews AJ. Psychological Outcomes and Mechanisms of Mindfulness-Based Training for Generalised Anxiety Disorder: A Systematic Review and Meta-Analysis. Curr Psychol. 2023 May 11:1-23. doi: 10.1007/s12144-023-04695-x. Online ahead of print.
citation: World Health Organization. (2017). Depression and other common mental disorders: global health estimates. World Health Organization.
citation: Yu DS. Insomnia Severity Index: psychometric properties with Chinese community-dwelling older people. J Adv Nurs. 2010 Oct;66(10):2350-9. doi: 10.1111/j.1365-2648.2010.05394.x. Epub 2010 Aug 16.
citation: Zhong J, Wang C, Li J, Liu J. Penn State Worry Questionnaire: structure and psychometric properties of the Chinese version. J Zhejiang Univ Sci B. 2009 Mar;10(3):211-8. doi: 10.1631/jzus.B0820189.