Anxiety Disorders Clinical Trial
Official title:
Treatment of Emotional Disorders in Spanish Children: Efficacy of Super Skills for Life Transdiagnostic Treatment
NCT number | NCT05482724 |
Other study ID # | 2018/034 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2, 2018 |
Est. completion date | December 14, 2022 |
Verified date | May 2023 |
Source | Universidad Miguel Hernandez de Elche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Super Skills for Life (SSL) is a transdiagnostic cognitive-behavioral protocol developed for children aged 6 to 12 with anxiety and comorbid problems (e.g., depression, low self-esteem, and lack of social skills). SSL consists of eight sessions targeting common risk factors for internalizing disorders such as cognitive distortions, avoidance, emotional management, low self-esteem, social skills deficits and coping strategies. The aim of the study is to investigate the short- and long-term effects of SSL on internalizing and externalizing symptoms in Spanish children attending the Child and Adolescent Mental Health Services.
Status | Completed |
Enrollment | 74 |
Est. completion date | December 14, 2022 |
Est. primary completion date | December 14, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 12 Years |
Eligibility | Inclusion Criteria: - Children aged 8 - 12. - Primary diagnosis of an anxiety disorder, a depressive disorder, and/or trauma- or stress-related disorder with anxiety and/or depressive symptoms. - Speaking, reading, writing and understanding Spanish. - Caregivers agree to attend all sessions and to receive feedback and suggestions. Exclusion Criteria: - Intellectual disability, behavioral symptoms, or autism spectrum symptoms whose severity precluded continued treatment. - The child is at the same time in psychological treatment. - The child is not on a stable dose of medication for at least 1 month prior to baseline assessment. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clínico Universitario Valencia | Valence | Valencia |
Lead Sponsor | Collaborator |
---|---|
Universidad Miguel Hernandez de Elche |
Spain,
Escribano S, Espada JP, Orgiles M, Morales A. Implementation fidelity for promoting the effectiveness of an adolescent sexual health program. Eval Program Plann. 2016 Dec;59:81-87. doi: 10.1016/j.evalprogplan.2016.08.008. Epub 2016 Aug 31. — View Citation
Essau CA, Olaya B, Sasagawa S, Pithia J, Bray D, Ollendick TH. Integrating video-feedback and cognitive preparation, social skills training and behavioural activation in a cognitive behavioural therapy in the treatment of childhood anxiety. J Affect Disord. 2014;167:261-7. doi: 10.1016/j.jad.2014.05.056. Epub 2014 Jun 4. — View Citation
Essau CA, Sasagawa S, Jones G, Fernandes B, Ollendick TH. Evaluating the real-world effectiveness of a cognitive behavior therapy-based transdiagnostic program for emotional problems in children in a regular school setting. J Affect Disord. 2019 Jun 15;253:357-365. doi: 10.1016/j.jad.2019.04.036. Epub 2019 Apr 16. — View Citation
Fernandez-Martinez I, Morales A, Espada JP, Orgiles M. Effects of Super Skills for Life on the social skills of anxious children through video analysis. Psicothema. 2020 May;32(2):229-236. doi: 10.7334/psicothema2019.240. — View Citation
Fernandez-Martinez I, Orgiles M, Morales A, Espada JP, Essau CA. One-Year follow-up effects of a cognitive behavior therapy-based transdiagnostic program for emotional problems in young children: A school-based cluster-randomized controlled trial. J Affect Disord. 2020 Feb 1;262:258-266. doi: 10.1016/j.jad.2019.11.002. Epub 2019 Nov 4. — View Citation
Melero S, Morales A, Espada JP, Mendez X, Orgiles M. Effectiveness of Group vs. Individual Therapy to Decrease Peer Problems and Increase Prosociality in Children. Int J Environ Res Public Health. 2021 Apr 9;18(8):3950. doi: 10.3390/ijerph18083950. — View Citation
Melero S, Morales A, Espada JP, Orgiles M. Improving Social Performance Through Video-feedback with Cognitive Preparation in Children with Emotional Problems. Behav Modif. 2022 Jul;46(4):755-781. doi: 10.1177/0145445521991098. Epub 2021 Jan 29. — View Citation
Melero S, Orgiles M, Espada JP, Morales A. Spanish version of Super Skills for Life in individual modality: Improvement of children's emotional well-being from a transdiagnostic approach. J Clin Psychol. 2021 Oct;77(10):2187-2202. doi: 10.1002/jclp.23148. Epub 2021 Apr 21. — View Citation
Orgiles M, Fernandez-Martinez I, Espada JP, Morales A. Spanish version of Super Skills for Life: short- and long-term impact of a transdiagnostic prevention protocol targeting childhood anxiety and depression. Anxiety Stress Coping. 2019 Nov;32(6):694-710. doi: 10.1080/10615806.2019.1645836. Epub 2019 Jul 23. — View Citation
Orgiles M, Melero S, Fernandez-Martinez I, Espada JP, Morales A. Effectiveness of Video-Feedback with Cognitive Preparation in Improving Social Performance and Anxiety through Super Skills for Life Programme Implemented in a School Setting. Int J Environ Res Public Health. 2020 Apr 18;17(8):2805. doi: 10.3390/ijerph17082805. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline diagnosis based on DSM-5 criteria to immediately after the intervention | Measured by Schedule for affective disorders and schizophrenia for schoolage youths-present and lifetime version (K-SADS-PL). The K-SADS-PL is a semi-structured interview for children and adolescents aged 6 to 18 years according to DSM-IV criteria. Additional questions were included in this study to obtain a diagnosis according to the current DSM-5 classification. | baseline and immediately after the intervention | |
Primary | Diagnosis based on DSM-5 criteria at 3 months | Measured by Schedule for affective disorders and schizophrenia for schoolage youths-present and lifetime version (K-SADS-PL). The K-SADS-PL is a semi-structured interview for children and adolescents aged 6 to 18 years according to DSM-IV criteria. Additional questions were included in this study to obtain a diagnosis according to the current DSM-5 classification. | 3 months after the intervention | |
Primary | Diagnosis based on DSM-5 criteria at 6 months | Measured by Schedule for affective disorders and schizophrenia for schoolage youths-present and lifetime version (K-SADS-PL). The K-SADS-PL is a semi-structured interview for children and adolescents aged 6 to 18 years according to DSM-IV criteria. Additional questions were included in this study to obtain a diagnosis according to the current DSM-5 classification. | 6 months after the intervention | |
Primary | Diagnosis based on DSM-5 criteria at 1 year | Measured by Schedule for affective disorders and schizophrenia for schoolage youths-present and lifetime version (K-SADS-PL). The K-SADS-PL is a semi-structured interview for children and adolescents aged 6 to 18 years according to DSM-IV criteria. Additional questions were included in this study to obtain a diagnosis according to the current DSM-5 classification. | 1 year after the intervention | |
Primary | Change from baseline depression symptoms to immediately after the intervention | Measured by Child Depression Inventory (CDI). It assess depressive symptoms experienced in the past two weeks. The CDI provides an overall score (minimum value 0, maximum value 54) and two dimensions values: dysphoria (minimum value 0, maximum value 34), and negative self-esteem (minimum value 0, maximum value 20). Higher scores indicate more severe symptoms. | baseline and immediately after the intervention | |
Primary | Depression symptoms at 3 months | Measured by Child Depression Inventory (CDI). It assess depressive symptoms experienced in the past two weeks. The CDI provides an overall score (minimum value 0, maximum value 54) and two dimensions values: dysphoria (minimum value 0, maximum value 34), and negative self-esteem (minimum value 0, maximum value 20). Higher scores indicate more severe symptoms. | 3 months after the intervention | |
Primary | Depression symptoms at 6 months | Measured by Child Depression Inventory (CDI). It assess depressive symptoms experienced in the past two weeks. The CDI provides an overall score (minimum value 0, maximum value 54) and two dimensions values: dysphoria (minimum value 0, maximum value 34), and negative self-esteem (minimum value 0, maximum value 20). Higher scores indicate more severe symptoms. | 6 months after the intervention | |
Primary | Depression symptoms at 1 year | Measured by Child Depression Inventory (CDI). It assess depressive symptoms experienced in the past two weeks. The CDI provides an overall score (minimum value 0, maximum value 54) and two dimensions values: dysphoria (minimum value 0, maximum value 34), and negative self-esteem (minimum value 0, maximum value 20). Higher scores indicate more severe symptoms. | 1 year after the intervention | |
Primary | Change from baseline parent-reported anxiety symptoms to immediately after the intervention | Measured by Spence Children's Anxiety Scale Parent Report (SCAS-P). SCAS-P measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms. | baseline and immediately after the intervention | |
Primary | Change from baseline children's reported anxiety symptoms to immediately after the intervention | Measured by Spence Children's Anxiety Scale Child Report (SCAS). SCAS measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms. | baseline and immediately after the intervention | |
Primary | Parent-reported anxiety symptoms at 3 months | Measured by Spence Children's Anxiety Scale Parent Report (SCAS-P). SCAS-P measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms. | 3 months after the intervention | |
Primary | Children's reported anxiety symptoms at 3 months | Measured by Spence Children's Anxiety Scale Child Report (SCAS). SCAS measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms. | 3 months after the intervention | |
Primary | Parent-reported anxiety symptoms at 6 months | Measured by Spence Children's Anxiety Scale Parent Report (SCAS-P). SCAS-P measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms. | 6 months after the intervention | |
Primary | Children's reported anxiety symptoms at 6 months | Measured by Spence Children's Anxiety Scale Child Report (SCAS). SCAS measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms. | 6 months after the intervention | |
Primary | Parent-reported anxiety symptoms at 1 year | Measured by Spence Children's Anxiety Scale Parent Report (SCAS-P). SCAS-P measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms. | 1 year after the intervention | |
Primary | Children's reported anxiety symptoms at 1 year | Measured by Spence Children's Anxiety Scale Child Report (SCAS). SCAS measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms. | 1 year after the intervention | |
Primary | Change from baseline parent-reported anxiety-related interference to immediately after the intervention | Measured by Child Anxiety Life Interference Scale Parent Report (CALIS-P). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 64. Higher scores indicate larger child anxiety-related interference. | baseline and immediately after the intervention | |
Primary | Change from baseline children's reported anxiety-related interference to immediately after the intervention | Measured by Child Anxiety Life Interference Scale Child Report (CALIS-C). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 36. Higher scores indicate larger child anxiety-related interference. | baseline and immediately after the intervention | |
Primary | Parent-reported anxiety-related interference at 3 months | Measured by Child Anxiety Life Interference Scale Parent Report (CALIS-P). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 64. Higher scores indicate larger child anxiety-related interference. | 3 months after the intervention | |
Primary | Children's reported anxiety-related interference at 3 months | Measured by Child Anxiety Life Interference Scale Child Report (CALIS-C). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 36. Higher scores indicate larger child anxiety-related interference. | 3 months after the intervention | |
Primary | Parent-reported anxiety-related interference at 6 months | Measured by Child Anxiety Life Interference Scale Parent Report (CALIS-P). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 64. Higher scores indicate larger child anxiety-related interference. | 6 months after the intervention | |
Primary | Children's reported anxiety-related interference at 6 months | Measured by Child Anxiety Life Interference Scale Child Report (CALIS-C). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 36. Higher scores indicate larger child anxiety-related interference. | 6 months after the intervention | |
Primary | Parent-reported anxiety-related interference at 1 year | Measured by Child Anxiety Life Interference Scale Parent Report (CALIS-P). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 64. Higher scores indicate larger child anxiety-related interference. | 1 year after the intervention | |
Primary | Children's reported anxiety-related interference at 1 year | Measured by Child Anxiety Life Interference Scale Child Report (CALIS-C). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 36. Higher scores indicate larger child anxiety-related interference. | 1 year after the intervention | |
Secondary | Change from baseline children's reported global mental health symptoms to immediately after the intervention | Measured by Strengths and Difficulties Questionnaire Child Report (SDQ). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximun value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. . Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute. | baseline and immediately after the intervention | |
Secondary | Change from baseline parent's reported global mental health symptoms to immediately after the intervention | Measured by Strengths and Difficulties Questionnaire Parent Report (SDQ-P). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximum value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. . Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute. | baseline and immediately after the intervention | |
Secondary | Children's reported global mental health symptoms at 3 months | Measured by Strengths and Difficulties Questionnaire Child Report (SDQ). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximun value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. . Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute. | 3 months after the intervention | |
Secondary | Parent's reported global mental health symptoms at 3 months | Measured by Strengths and Difficulties Questionnaire Parent Report (SDQ-P). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximum value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. . Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute. | 3 months after the intervention | |
Secondary | Children's reported global mental health symptoms at 6 months | Measured by Strengths and Difficulties Questionnaire Child Report (SDQ). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximun value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. . Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute. | 6 months after the intervention | |
Secondary | Parent's reported global mental health symptoms at 6 months | Measured by Strengths and Difficulties Questionnaire Parent Report (SDQ-P). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximum value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. . Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute. | 6 months after the intervention | |
Secondary | Children's reported global mental health symptoms at 1 year | Measured by Strengths and Difficulties Questionnaire Child Report (SDQ). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximun value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. . Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute. | 1 year after the intervention | |
Secondary | Parent's reported global mental health symptoms at 1 year | Measured by Strengths and Difficulties Questionnaire Parent Report (SDQ-P). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximum value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. . Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute. | 1 year after the intervention | |
Secondary | Change from baseline self-esteem to immediately after the intervention | Self-Concept Form 5 (AF-5). It measures global satisfaction with self-concept (minimum value 0 and maximum value 120) and five dimensions (minimum value 0 and maximum value 24): Social (performance in social relationships); Academic/Professional (student/worker role); Emotional (perception of emotional state in general and in specific situations); Family (participation and integration into the family unit); and Physical self-concept (appearance and physical condition). Higher scores indicate greater satisfaction with self-image. | baseline and immediately after the intervention | |
Secondary | Self-esteem at 3 months | Self-Concept Form 5 (AF-5). It measures global satisfaction with self-concept (minimum value 0 and maximum value 120) and five dimensions (minimum value 0 and maximum value 24): Social (performance in social relationships); Academic/Professional (student/worker role); Emotional (perception of emotional state in general and in specific situations); Family (participation and integration into the family unit); and Physical self-concept (appearance and physical condition). Higher scores indicate greater satisfaction with self-image. | 3 months after the intervention | |
Secondary | Self-esteem at 6 months | Self-Concept Form 5 (AF-5). It measures global satisfaction with self-concept (minimum value 0 and maximum value 120) and five dimensions (minimum value 0 and maximum value 24): Social (performance in social relationships); Academic/Professional (student/worker role); Emotional (perception of emotional state in general and in specific situations); Family (participation and integration into the family unit); and Physical self-concept (appearance and physical condition). Higher scores indicate greater satisfaction with self-image. | 6 months after the intervention | |
Secondary | Self-esteem at 1 year | Self-Concept Form 5 (AF-5). It measures global satisfaction with self-concept (minimum value 0 and maximum value 120) and five dimensions (minimum value 0 and maximum value 24): Social (performance in social relationships); Academic/Professional (student/worker role); Emotional (perception of emotional state in general and in specific situations); Family (participation and integration into the family unit); and Physical self-concept (appearance and physical condition). Higher scores indicate greater satisfaction with self-image. | 1 year after the intervention | |
Secondary | Perfectionism | Frost Multidimensional Perfectionism Scale (FMPS). A self-report measure with four sub-scales of perfectionism: concern over mistakes and doubts about actions, excessive concern with parents' expectations and evaluation, excessively high personal standards, concern with precision, order and organisation. | pre-intervention | |
Secondary | Changes from baseline health-related quality of life to immediately after the intervention | Health-Related Quality of Life Questionnaire for Children and Adolescents aged from 8 to 18 years (KIDSCREEN). It assess children's and parents' subjective health and well-being in 10 areas. | baseline and immediately after the intervention | |
Secondary | Health-related quality of life at 3 months | Health-Related Quality of Life Questionnaire for Children and Adolescents aged from 8 to 18 years (KIDSCREEN). It assess children's and parents' subjective health and well-being in 10 areas. | 3 months after the intervention | |
Secondary | Health-related quality of life at 6 months | Health-Related Quality of Life Questionnaire for Children and Adolescents aged from 8 to 18 years (KIDSCREEN). It assess children's and parents' subjective health and well-being in 10 areas. | 6 months after the intervention | |
Secondary | Health-related quality of life at 1 year | Health-Related Quality of Life Questionnaire for Children and Adolescents aged from 8 to 18 years (KIDSCREEN). It assess children's and parents' subjective health and well-being in 10 areas. | 1 year after the intervention |
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