An interventional study of Improving Access to Community Therapies (iACT) in Depression, Anxiety and Mental Health Issue, sponsored by Mind Mental Health Hong Kong Limited. Recruiting at 21 sites in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-01.
Sponsored by Mind Mental Health Hong Kong Limited · Not applicable, Interventional, and Treatment
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:
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.
'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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 330 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →This is the only study on the registry with Mind Mental Health Hong Kong Limited as lead sponsor.
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18-65 years old adults with any of the following problem(s):
Exclusion Criteria:
Adults with the following features/ presentations are not eligible for the PWP programme and should automatically lead to an onward referral:
Individuals with any of the following diagnoses or situations are also excluded:
All participants enrolled in the programme will participate in the iACT service referring to the aforementioned details.
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.
Also known as: Manualised Acceptance and Commitment Therapy (ACT), Low-intensity Acceptance and Commitment Therapy (LIACT)
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.
Time frame: Pre-training, post-training (2nd month), during mid-placement review (6th month), and during end-of-placement (11th month)
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.
Time frame: Pre-training, post-training (2nd month), during mid-placement review (6th month), and during end-of-placement (11th month)
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.
Time frame: 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).
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.
Time frame: During clients' enrolment 2) before intake interview (week 0), weekly from session 1 to session 6, and before follow-up (week 12).
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.
Time frame: Before intake interview (week 0), after session 6 (week 6), and before follow-up (week 12).
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.
Time frame: Before intake interview (week 0), after session 6 (week 6), and before follow-up (week 12).
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.
Time frame: Before intake interview (week 0), after session 6 (week 6), and before follow-up (week 12).
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.
Time frame: Before session 1 (week 1), session 4 (week 4) and session 6 (week 6).
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.
Time frame: Before intake interview (week 0), after session 6 (week 6), and before follow-up (week 12).
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.
Time frame: Before intake interview (week 0), after session 6 (week 6), and before follow-up (week 12).
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