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Research of Unified Protocol for the Treatment of Common Mental Disorders in Adolescents in Hong Kong

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ClinicalTrials.gov Identifier: NCT04091139
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
Castle Peak Hospital
Information provided by (Responsible Party):
Sophie Yan Yan Cheung, Chinese University of Hong Kong

Brief Summary:

The Unified Protocol (UP) is an emotion-focused, cognitive-behavioural intervention that is developed to target core temperamental characteristics underlying anxiety and depressive disorders. Ehrenreich and colleagues developed UP for adolescents (UP-A). The current study aims at evaluating efficacy of UP-A for the treatment of emotional disorders in Chinese adolescents in Hong Kong.

The current study would recruit 27 Chinese-speaking patients, age 13 to 18, with a primary diagnosis of any Diagnostic and Statistical Manual (Fifth edition) anxiety disorders and/or depressive disorder. They would be randomized into one of the two treatment arms, namely UP-A treatment condition (UP-A), and treatment-as-usual (TAU) condition. Following randomization, participants in the UP-A condition would attend individual treatment based on UP-A, which last for 10 to 12 weeks. Participants in the TAU condition would be provided with usual clinical psychological service (i.e. treatment as usual) in the first 12 weeks before they start attending the same individual treatment program.

Primary outcomes would be patient's self-rated measures on clinical symptoms, and secondary outcomes would be their clinical diagnoses, parent-rated and other self-rated measures. It is hypothesized that, comparing to those in TAU, participants in the UP-A condition would show improvements in depressive symptoms, anxiety symptoms and functional impairment at the end of treatment. When the outcomes of all participants are combined, it is hypothesized that participants will show demonstrate improvement in depressive symptoms, anxiety symptoms, and functional impairment after completing the UP-A and at the 3-month follow-up.


Condition or disease Intervention/treatment Phase
Depressive Disorder Anxiety Disorders Behavioral: Unified protocol for adolescents (UP-A) Behavioral: Treatment as usual (TAU) Phase 2 Phase 3

Detailed Description:
A Chinese treatment protocol would be developed based on the UP-A. The adolescent program consists of 8 modules, and the parent program consists of 3 modules. Similar to the work by Ehrenreich and Barlow, a flexible modular approach would be adopted, when extra sessions would be arranged to cater for individual treatment needs and heterogeneity of symptom severity. The whole treatment comprised of 10 to 12 individual sessions for the adolescents, and 4 to 6 sessions for parents or guardian. The total duration would be around 3 months. Each treatment sessions would be around 1 hour.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This study is to examine the effect of transdiagnostic cognitive behavioural therapy (Unified Protocol for adolescents, UP-A), in comparison with treatment-as-usual, in the reduction of depressive and anxiety symptoms among adolescents with common mental disorders.

All participants would be randomized into one of the two treatment arms, namely UP-A treatment condition (UP-A) and treatment-as-usual (TAU) condition. Following randomization, participants in UP-A condition would attend individual psychological treatment based on UP-A, which last for 10 to 12 weeks. Participants in the TAU condition would be provided with usual clinical psychological service (i.e. treatment as usual) in the first 12 weeks before they start attending the same individual treatment program based on UP-A.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized-controlled Trial of a Locally Adapted Unified Protocol - Transdiagnostic Cognitive Behavioural Therapy for the Treatment of Common Mental Disorders in Adolescents in Hong Kong
Actual Study Start Date : September 24, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Unified protocol for adolescents (UP-A)

The Unified Protocol (UP) is an emotion-focused, cognitive-behavioural intervention that is developed to target core temperamental characteristics underlying anxiety and depressive disorders. The goal of the UP is to help patients to cultivate a greater willingness to experience uncomfortable emotions and to reduce maladaptive emotion response tendencies, so as to lessen the intensity and frequency of uncomfortable emotions. Ehrenreich and colleagues modified from the original UP and developed the UP for adolescents (UP-A).

A Chinese treatment protocol would be developed based on the UP-A. Contents of the treatment includes motivational enhancement, psychoeducation of emotion, avoidance and emotion driven behaviours, interoceptive exposure, cognitive reappraisal, emotion awareness training and emotion exposure. It consists of 10 to 12 individual sessions for the adolescents, and 4 to 6 sessions for parents or guardians.

Behavioral: Unified protocol for adolescents (UP-A)

The Unified Protocol (UP) is an emotion-focused, cognitive-behavioural intervention that is developed to target core temperamental characteristics underlying anxiety and depressive disorders. The goal of the UP is to help patients to cultivate a greater willingness to experience uncomfortable emotions and to reduce maladaptive emotion response tendencies, so as to lessen the intensity and frequency of uncomfortable emotions. Ehrenreich and colleagues modified from the original UP and developed the UP for adolescents (UP-A).

A Chinese treatment protocol would be developed based on the UP-A. Contents of the treatment includes motivational enhancement, psychoeducation of emotion, avoidance and emotion driven behaviours, interoceptive exposure, cognitive reappraisal, emotion awareness training and emotion exposure. It consists of 10 to 12 individual sessions for the adolescents, and 4 to 6 sessions for parents or guardians.


Active Comparator: Treatment as usual (TAU)
TAU participants will receive usual clinical psychological service provided in the clinic (i.e. treatment as usual) in the first 12 weeks, before they start receiving same individual treatment program based on UP-A.
Behavioral: Treatment as usual (TAU)
TAU participants will receive usual clinical psychological service provided in the clinic (i.e. treatment as usual) in the first 12 weeks, before they start receiving same individual treatment program based on UP-A.




Primary Outcome Measures :
  1. Change of depressive symptoms from baseline to treatment completion and at the three-month follow-up [ Time Frame: UP-A: Week 0 (pre-treatment), Week 12 (post-treatment) and Week 24 (follow-up); TAU: Week 0 (baseline), Week 12 (pre-treatment), Week 24 (post-treatment) and Week 36 (follow-up) ]

    Beck Depression Inventory for Youth (BDI-Y)

    • One of the inventories in the Beck Youth Inventories of Emotional and Social Impairment (Second Edition, Chinese version).
    • Construct measured: depressive symptoms.
    • Total scores would be converted into T-scores (range from 20-81) and descriptive classifications (normal, mild, moderate and severe) according to aged-norm.
    • The higher the T-scores, the more severe the depressive symptoms.

  2. Change of anxiety symptoms from baseline to treatment completion and at the three-month follow-up [ Time Frame: UP-A: Week 0 (pre-treatment), Week 12 (post-treatment) and Week 24 (follow-up); TAU: Week 0 (baseline), Week 12 (pre-treatment), Week 24 (post-treatment) and Week 36 (follow-up) ]

    Beck Anxiety Inventory for Youth (BAI-Y)

    • One of the inventories in the Beck Youth Inventories of Emotional and Social Impairment (Second Edition, Chinese version).
    • Construct measured: anxiety symptoms.
    • Total scores would be converted into T-scores (range from 20-81) and descriptive classifications (normal, mild, moderate and severe) according to aged-norm.
    • The higher the T-scores, the more severe the anxiety symptoms.


Secondary Outcome Measures :
  1. Change of psychiatric diagnosis of common mental disorders (based on fifth edition of Diagnostic and Statistical Manual) from baseline to treatment completion [ Time Frame: UP-A: Week 0 (pre-treatment) and Week 12 (post-treatment); TAU: Week 0 (baseline), Week 12 (pre-treatment) and Week 24 (post-treatment) ]

    M.I.N.I. International Neuropsychiatric Interview for Children and Adolescent (MINIKID; English version 7.0.2)

    • Construct measured: psychiatric diagnoses.
    • Presence or absence of each of the following psychiatric diagnoses: major depressive disorder, bipolar disorder, panic disorder, agoraphobia, separation anxiety disorder, social anxiety disorder, specific phobia, obsessive-compulsive disorder, posttraumatic stress disorder, alcohol use disorder, substance use disorder, Tourette's disorder, attention-deficit/ hyperactivity disorder, conduct disorder, oppositional defiant disorder, psychotic disorder, anorexia nervosa, bulimia nervosa, binge eating disorder, generalized anxiety disorder, adjustment disorders and autism spectrum disorder.

  2. Change of level of suicidality from baseline to treatment completion [ Time Frame: UP-A: Week 0 (pre-treatment) and Week 12 (post-treatment); TAU: Week 0 (baseline), Week 12 (pre-treatment) and Week 24 (post-treatment) ]

    M.I.N.I. International Neuropsychiatric Interview for Children and Adolescent (MINIKID; English version 7.0.2) - Part B "Suicidality (for ages 13 through 17)"

    • Construct measured: suicidality.
    • Total scores (range from 0-169) which would be converted into descriptive classifications (low, moderate and high).
    • The higher the total scores, the higher the suicidality.

  3. Change of functional impairment from baseline to treatment completion and at the three-month follow-up [ Time Frame: UP-A: Week 0 (pre-treatment), Week 12 (post-treatment) and Week 24 (follow-up); TAU: Week 0 (baseline), Week 12 (pre-treatment), Week 24 (post-treatment) and Week 36 (follow-up) ]

    Sheehan Disability Scale (SDS, 2012 version)

    • Construct measures: impairments in daily life.
    • Three separate impairment scores (each range from 0-10) on the domains of work/school, social life and family life/home responsibility.
    • The higher the impairment scores, the more the impairments.

  4. Change of self-reported competencies and psychopathologies from baseline to treatment completion and at the three-month follow-up [ Time Frame: UP-A: Week 0 (pre-treatment), Week 12 (post-treatment) and Week 24 (follow-up); TAU: Week 0 (baseline), Week 12 (pre-treatment), Week 24 (post-treatment) and Week 36 (follow-up) ]

    Youth Self-report (YSR; 1991 & 2001 combined version, Chinese edition)

    • Construct measures: competencies and psychopathologies.
    • The competence scale consists of the activities and social subscales. Subscale total scores would be converted into T-scores (range from 20-55). A Total Competence Scale is computed from subscale scores, and would be converted into T-scores (range from 10-80). Descriptive classifications (normal, borderline and clinical) would be obtained from T-scores. The higher the T-score, the higher the competence.
    • The problem scale consists of the internalizing and externalizing problem subscales. Subscale total scores would be converted into T-scores (range from 26-100). A Total Problem Scale is computed from problem items, and would be converted into T-scores (range from 19-100). Descriptive classifications (normal, borderline and clinical) would be obtained from T-scores. The higher the T-score, the more severe the problems.

  5. Change of parental-reported competencies and psychopathologies from baseline to treatment completion and at the three-month follow-up [ Time Frame: UP-A: Week 0 (pre-treatment), Week 12 (post-treatment) and Week 24 (follow-up); TAU: Week 0 (baseline), Week 12 (pre-treatment), Week 24 (post-treatment) and Week 36 (follow-up) ]

    Child Behavior Checklist (CBCL; 1991 & 2001 combined version, Chinese edition)

    • Construct measures: competencies and psychopathologies.
    • The competence scale consists of the activities, social and school subscales. Subscale total scores would be converted into T-scores (range from 20-55). A Total Competence Scale is computed from subscale scores, and would be converted into T-scores (range from 10-80). Descriptive classifications (normal, borderline and clinical) would be obtained from T-scores. The higher the T-score, the higher the competence.
    • The problem scale consists of the internalizing and externalizing problem subscales. Subscale total scores would be converted into T-scores (range from 29-100). A Total Problem Scale is computed from problem items, and would be converted into T-scores (range from 23-100). Descriptive classifications (normal, borderline and clinical) would be obtained from T-scores. The higher the T-score, the more severe the problems.

  6. Change of depressive symptoms throughout the treatment, from baseline to treatment completion and at the three-month follow-up [ Time Frame: UP-A: Week 0 (pre-treatment), Week 1-12 (10-12 treatment sessions), Week 12 (post-treatment), Week 24 (follow-up); TAU: Week 0 (baseline), Week 12 (pre-treatment), Week 13-24 (10-12 treatment sessions), Week 24 (post-treatment), Week 36 (follow-up) ]

    Patient Health Questionnaire (PHQ-9)

    • Construct measured: depressive symptoms
    • Total scores (range from 0-27) and would be converted into descriptive classifications (normal, mild, moderate, moderately-severe and severe)
    • The higher the T-scores, the more severe the depressive symptoms

  7. Change of anxiety symptoms throughout the treatment, from baseline to treatment completion and at the three-month follow-up [ Time Frame: UP-A: Week 0 (pre-treatment), Week 1-12 (10-12 treatment sessions), Week 12 (post-treatment), Week 24 (follow-up); TAU: Week 0 (baseline), Week 12 (pre-treatment), Week 13-24 (10-12 treatment sessions), Week 24 (post-treatment), Week 36 (follow-up) ]

    Generalized Anxiety Disorder Questionnaire (GAD-7)

    • Construct measured: anxiety symptoms
    • Total scores (range from 0-21) and would be converted into descriptive classifications (normal, mild, moderate, and severe)
    • The higher the T-scores, the more severe the anxiety symptoms

  8. Change of self-reported problem severity throughout the treatment, from baseline to treatment completion and at the three-month follow-up [ Time Frame: UP-A: Week 0 (pre-treatment), Week 1-12 (10-12 treatment sessions), Week 12 (post-treatment), Week 24 (follow-up); TAU: Week 0 (baseline), Week 12 (pre-treatment), Week 13-24 (10-12 treatment sessions), Week 24 (post-treatment), Week 36 (follow-up) ]

    Subjective rating of distress (SUDS)

    • Construct measured: subjective rating of problem severity
    • Participants are asked to list up to a maximum of 3 problems, and give a subjective rating of distress for each of the problem listed. An average score (range from 0-10) would be calculated.
    • The higher the average score, the more severe the problems.

  9. Change of parental-reported problem severity throughout the treatment, from baseline to treatment completion and at the three-month follow-up [ Time Frame: UP-A: Week 0 (pre-treatment), Week 1-12 (4-6 parent sessions), Week 12 (post-treatment), Week 24 (follow-up); TAU: Week 0 (baseline), Week 12 (pre-treatment), Week 13-24 (4-6 parent sessions), Week 24 (post-treatment), Week 36 (follow-up) ]

    Subjective rating of distress - parents (SUDS - parents)

    • Construct measured: parental rating of problem severity
    • Parents are asked to list up to a maximum of 3 problems faced by the participants, and give a subjective rating of distress for each of the problem listed. An average score (range from 0-10) would be calculated.
    • The higher the average score, the more severe the problems.


Other Outcome Measures:
  1. Self-reported subjective satisfaction towards treatment [ Time Frame: UP-A: Week 12 (post-treatment); TAU: Week 24 (post-treatment) ]

    Satisfaction survey

    • Construct measured: subjective rating of satisfaction towards treatment
    • Participants are asked to give subjective ratings of how easy it is to apply the skills introduced in the treatment, and how useful these skills (range from 0-10). The higher the scores, the easier or more useful the application of skills respectively.
    • Participants would also complete discrete ratings of whether or not they are satisfied with the treatment duration and treatment intensity respectively, and whether or not they would recommend the program to others.

  2. Parental-reported subjective satisfaction towards treatment [ Time Frame: UP-A: Week 12 (post-treatment); TAU: Week 24 (post-treatment) ]

    Satisfaction survey (parents)

    • Construct measured: subjective rating of satisfaction towards treatment
    • Parents are asked to give subjective ratings of satisfaction of treatment. An average score (range from 0-10) would be calculated from these ratings. The higher the average score, the higher the level of satisfaction.
    • Parents would also complete discrete ratings of whether or not they are satisfied with the treatment duration and treatment intensity respectively, and whether or not they would recommend the program to others.



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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 13 to 18 years.
  • Primary diagnosis of any depression and/or anxiety disorders in fifth edition of the Diagnostic and Statistical Manual
  • Use Chinese as primary written language
  • For adolescents on medication, there must be 6-week stabilization period before study entry

Exclusion Criteria:

  • Diagnoses of psychotic disorders, organic brain disease, bipolar disorder
  • In high risk of self-harm or suicide
  • Significant cognitive impairment (intellectual quotient lower than 80)
  • Autism Spectrum Disorders
  • Externalizing disorders with serious treatment interfering disruptive behavioural problems or substance abuse
  • Attending concurrent psychotherapy
  • Experience of attending a full-course of cognitive behavior therapy for anxiety or depression

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091139


Contacts
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Contact: Sophie Yan Yan Cheung, MSocSc (852)24567111 cheungyy@ha.org.hk

Locations
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Hong Kong
Department of Psychology, The Chinese University of Hong Kong Recruiting
Hong Kong, HK, Hong Kong, HK
Contact: Patrick Wing-leung Leung, PhD    (852)39436650    pleung@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Castle Peak Hospital
Investigators
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Principal Investigator: Sophie Yan Yan Cheung, MSocSc Chinese University of Hong Kong

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Responsible Party: Sophie Yan Yan Cheung, Clinical Psychologist, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04091139     History of Changes
Other Study ID Numbers: UPAHK01
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sophie Yan Yan Cheung, Chinese University of Hong Kong:
Unified Protocol
Cognitive Behavioural Therapy
Depression
Anxiety
Adolescents
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Anxiety Disorders
Mental Disorders
Psychotic Disorders
Pathologic Processes
Mood Disorders
Schizophrenia Spectrum and Other Psychotic Disorders