Depressive DisorderPhase 2/3NCT04091139
Research of Unified Protocol for the Treatment of Common Mental Disorders in Adolescents in Hong Kong
A Phase 2/3 study testing Unified protocol for adolescents (UP-A) and Treatment as usual (TAU) in people with Depressive Disorder and Anxiety Disorders, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Depressive Disorder, Anxiety Disorders
- What is being tested?
- Unified protocol for adolescents (UP-A) and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteHong Kong
- Study dates
- 24 Sep 2019to 22 May 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Psychology, The Chinese University of Hong Kong
Hong Kong, HK, HK
About this study
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
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.
Read the 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.
- Conditions
- Depressive Disorder, Anxiety Disorders
- Being tested
- Unified protocol for adolescents (UP-A), Treatment as usual (TAU)
- Keywords
- Unified Protocol, Cognitive Behavioural Therapy, Depression, Anxiety, Adolescents
- Medical subject headings
- Depressive Disorder, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified protocol for adolescents (UP-A)Behavioural
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.
Treatment as usual (TAU)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Unified protocol for adolescents (UP-A) | Experimental | 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. Receives: Behavioral: Unified protocol for adolescents (UP-A) |
| Treatment as usual (TAU) | Active comparator | 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. Receives: Behavioral: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of depressive symptoms from baseline to treatment completion and at the three-month 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.
Measured: 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)
Change of anxiety symptoms from baseline to treatment completion and at the three-month 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.
Measured: 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)
Secondary outcomes (9)
Change of psychiatric diagnosis of common mental disorders (based on fifth edition of Diagnostic and Statistical Manual) from baseline to treatment completion
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.
Measured: UP-A: Week 0 (pre-treatment) and Week 12 (post-treatment); TAU: Week 0 (baseline), Week 12 (pre-treatment) and Week 24 (post-treatment)
Change of level of suicidality from baseline to treatment completion
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.
Measured: UP-A: Week 0 (pre-treatment) and Week 12 (post-treatment); TAU: Week 0 (baseline), Week 12 (pre-treatment) and Week 24 (post-treatment)
Change of functional impairment from baseline to treatment completion and at the three-month 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.
Measured: 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)
Change of self-reported competencies and psychopathologies from baseline to treatment completion and at the three-month 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.
Measured: 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)
Change of parental-reported competencies and psychopathologies from baseline to treatment completion and at the three-month 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.
Measured: 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)
Change of depressive symptoms throughout the treatment, from baseline to treatment completion and at the three-month 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
Measured: 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)
Change of anxiety symptoms throughout the treatment, from baseline to treatment completion and at the three-month 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
Measured: 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)
Change of self-reported problem severity throughout the treatment, from baseline to treatment completion and at the three-month 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.
Measured: 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)
Change of parental-reported problem severity throughout the treatment, from baseline to treatment completion and at the three-month 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start24 Sep 2019
- Primary completion22 May 2020
- Study completion22 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Castle Peak Hospital
- Responsible party
- Principal investigator, Sophie Yan Yan Cheung, Chinese University of Hong Kong
- Investigators
- Sophie Yan Yan Cheung, MSocSc, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091139
- Sponsor's protocol ID
- UPAHK01
- Status last verified
- Jan 2021
- First submitted
- 11 Sep 2019
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04091139
- Acronym / sponsor ID
- UPAHK01
- Conditions
- Depressive Disorder, Anxiety Disorders
- Keywords
- Unified Protocol, Cognitive Behavioural Therapy, Depression, Anxiety, Adolescents
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Castle Peak Hospital
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 22 May 2020 (actual)
- Study completion
- 22 May 2020 (actual)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Unified protocol for adolescents (UP-A) | Experimental | 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. |
| Treatment as usual (TAU) | Active comparator | 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Unified protocol for adolescents (UP-A) |
| 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. | Behavioural | Treatment as usual (TAU) |
Primary outcome
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.
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.
9 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Yan Yan Cheung, MSocSc principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Unified protocol for adolescents (UP-A) and Treatment as usual (TAU) in people with Depressive Disorder and Anxiety Disorders, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.