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

Depression Clinical Trial

— iACT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06111820
• Other study ID #: MHK/2023/R01-PWP
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2022
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: Mind Mental Health Hong Kong Limited
• Contact: Jacky Chow
• Phone: +852 9145 2584
• Email: jacky.chow[@]mind.org.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Depression
• Distress, Emotional
• Mental Health Issue
• Stress

Intervention

Behavioral:
• Improving Access to Community Therapies (iACT)
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.

Locations

Country	Name	City	State
China	Aberdeen Kai-fong Welfare Association Services Centre	Hong Kong
China	Baptist Oi Kwan Social Service	Hong Kong
China	Cedar Communications Ltd	Hong Kong
China	Central Health	Hong Kong
China	Central Minds	Hong Kong
China	Fu Hong Society	Hong Kong
China	HKU Lap-Chee College	Hong Kong
China	HKUSPACE PLK Stanley Ho Community College	Hong Kong
China	Hong Kong Physically Handicapped and Able-Bodied (PHAB) Association	Hong Kong
China	KUNST EXA Academy	Hong Kong
China	LU Institute of Further Education	Hong Kong
China	Mind Mental Health Hong Kong Limited	Hong Kong
China	MINDSET	Hong Kong
China	PathFinders Hong Kong	Hong Kong
China	Run HK	Hong Kong
China	Society for Community Organisation (SoCO)	Hong Kong
China	St. John's Cathedral Counselling Service	Hong Kong
China	The Hong Kong Federation of Youth Groups	Hong Kong
China	The Mental Health Association of Hong Kong	Hong Kong
China	WYNG Foundation	Hong Kong
China	Yuen Long Town Hall	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Mind Mental Health Hong Kong Limited	Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-training, post-training (2nd month), during mid-placement review (6th month), and during end-of-placement (11th month)
Primary	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.	Pre-training, post-training (2nd month), during mid-placement review (6th month), and during end-of-placement (11th month)
Primary	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.	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).
Primary	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.	During clients' enrolment 2) before intake interview (week 0), weekly from session 1 to session 6, and before follow-up (week 12).
Primary	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.	Before intake interview (week 0), after session 6 (week 6), and before follow-up (week 12).
Primary	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.	Before intake interview (week 0), after session 6 (week 6), and before follow-up (week 12).
Secondary	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.	Before intake interview (week 0), after session 6 (week 6), and before follow-up (week 12).
Secondary	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.	Before session 1 (week 1), session 4 (week 4) and session 6 (week 6).
Secondary	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.	Before intake interview (week 0), after session 6 (week 6), and before follow-up (week 12).
Secondary	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.	Before intake interview (week 0), after session 6 (week 6), and before follow-up (week 12).

External Links

•   Enrolment website of the iACT intervention services.