NCT06111820

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
330

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started May 2022

Typical duration for not_applicable depression

Geographic Reach
1 country

21 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

2.3 years

First QC Date

October 10, 2023

Last Update Submit

October 26, 2023

Conditions

Keywords

PsychotherapiesPsychological therapiesEvaluationImproving accessCommunity therapyCommunity therapiesLow-intensityAcceptance and Commitment TherapyACT

Outcome Measures

Primary Outcomes (6)

  • 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)

  • 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)

  • 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).

  • 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).

  • 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).

  • 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 Outcomes (4)

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

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

  • Brief Revised Working Alliance Inventory (BR-WAI)

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

  • Brief Experiential Avoidance Questionnaire (BEAQ)

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

  • Acceptance and Action Questionnaire II (AAQ-II)

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

Study Arms (1)

iACT service users

EXPERIMENTAL

All participants enrolled in the programme will participate in the iACT service referring to the aforementioned details.

Behavioral: Improving Access to Community Therapies (iACT)

Interventions

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)
iACT service users

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Aberdeen Kai-fong Welfare Association Services Centre

Hong Kong, China

RECRUITING

Baptist Oi Kwan Social Service

Hong Kong, China

RECRUITING

Cedar Communications Ltd

Hong Kong, China

RECRUITING

Central Health

Hong Kong, China

RECRUITING

Central Minds

Hong Kong, China

RECRUITING

Fu Hong Society

Hong Kong, China

RECRUITING

HKU Lap-Chee College

Hong Kong, China

RECRUITING

HKUSPACE PLK Stanley Ho Community College

Hong Kong, China

RECRUITING

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

Hong Kong, China

RECRUITING

KUNST EXA Academy

Hong Kong, China

RECRUITING

LU Institute of Further Education

Hong Kong, China

RECRUITING

Mind Mental Health Hong Kong Limited

Hong Kong, China

RECRUITING

MINDSET

Hong Kong, China

RECRUITING

PathFinders Hong Kong

Hong Kong, China

RECRUITING

Run HK

Hong Kong, China

RECRUITING

Society for Community Organisation (SoCO)

Hong Kong, China

RECRUITING

St. John's Cathedral Counselling Service

Hong Kong, China

RECRUITING

The Hong Kong Federation of Youth Groups

Hong Kong, China

RECRUITING

The Mental Health Association of Hong Kong

Hong Kong, China

RECRUITING

WYNG Foundation

Hong Kong, China

RECRUITING

Yuen Long Town Hall

Hong Kong, China

RECRUITING

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Related Links

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Candice LYM Powell

    Mind Mental Health Hong Kong Limited

    PRINCIPAL INVESTIGATOR
  • Patrick WL Leung

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2023

First Posted

November 1, 2023

Study Start

May 22, 2022

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

November 1, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations