Effectiveness of Traditional and Computerized Versions of Super Skills for Life in Children

January 29, 2024 updated by: Mireia Orgilés Amorós, Universidad Miguel Hernandez de Elche

Comparative Effectiveness of Traditional and Computerized Versions of the Transdiagnostic Program Super Skills for Life in Children Aged 8-12 Years: a Randomized Controlled Trial

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 comparative effectiveness of SSL in its traditional and computerized versions on internalizing symptoms in Spanish children between 8 and 12 years of age.

Study Overview

Detailed Description

Children will be selected to receive the SSL program based on results on psychometrically robust measurements and inclusion/exclusion criteria. Selected children will be randomly assigned to the conditions of the two intervention groups (traditional and computerized versions of SSL).

Parents and children from the two groups will complete the same measures at baseline and post-treatment. They will also complete these measures at 6 months follow-up, and 12 months follow-up.

Researchers will compare the results of pre-test to post-test assessments in children participating in the traditional and multimedia versions of SSL on depressive symptoms, anxiety symptoms, interference of anxiety on child's life, self-esteem, social skills, social worries, and cognitive emotional regulation.

The investigators will also assess these variables in the intervention group at 6 months and 12 months follow-up.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alicante
      • Elche, Alicante, Spain, 03202
        • Department of Health Psychology. Miguel Hernandez University of Elche

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children aged 8 - 12 years old.
  • Presence of emotional symptoms, which will be assessed using the SCAS and the MFQ, parent versions. The cut-off point for inclusion in the study is a score equal to or above 25 on the SCAS and/or equal to or above 20 on the MFQ.
  • Speaking, reading, writing and understanding Spanish.

Exclusion Criteria:

  • Intellectual disability, behavioral symptoms, or autism spectrum symptoms whose severity precluded continued treatment.
  • Being receiving current psychological or pharmacological treatment for anxiety and/or depression.
  • Not accepting or revoking informed consent to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Super Skills for Life intervention group: traditional version
The Super Skills for Life program will be administered following the manual of the intervention by a trained therapist, as described in the section of intervention/treatment.

Structured and manualized intervention with a manual for the therapist and a workbook for the children.

The intervention will be administered by trained clinical psychologists in SSL. Sessions will be held once a week for eight weeks, with each session lasting approximately forty five minutes.

The program includes emotional education, social skills training, cognitive restructuring, relaxation techniques, self-observation, problem solving and behavioural activation. These contents are learned through playful exercises, activities, readings, and role-playing.

Both modalities of intervention will be in-person.

Spanish version of Super Skills for Life group program: Orgilés, M., Espada, J.P., Ollendick, T.H. & Essau, C. (2022). Programa Super Skills. Manual del aplicador. Elche, ES: Universidad Miguel Hernández.

Experimental: Super Skills for Life intervention group: computerized version

The Super Skills for Life program will be administered in-person as well by a trained therapist, as described in the section of intervention treatment.

The therapist will use the multimedia presentation of the program's contents as a tool for the better development of the sessions. The digital version of the program consists of an animation whose characters narrate examples that help the children better understand the contents. The therapist will have a password assigned to each child, and it will be the therapist who will guide the sessions and select the contents of the digital presentation that correspond to each session. The web address to access the programme is https://www.superskillsonline.com/.

Structured and manualized intervention with a manual for the therapist and multimedia material for the children.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline children's reported anxiety symptoms
Time Frame: Baseline
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
Children's reported anxiety symptoms immediately after the intervention
Time Frame: 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.
Immediately after the intervention
Children's reported anxiety symptoms at 6 months
Time Frame: 6 months 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.
6 months after the intervention
Children's reported anxiety symptoms at 12 months
Time Frame: 12 months 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.
12 months after the intervention
Baseline parent-reported anxiety symptoms
Time Frame: Baseline
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
Parent-reported anxiety symptoms immediately after the intervention
Time Frame: 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.
Immediately after the intervention
Parent-reported anxiety symptoms immediately at 6 months
Time Frame: 6 months 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.
6 months after the intervention
Parent-reported anxiety symptoms immediately at 12 months
Time Frame: 12 months 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.
12 months after the intervention
Baseline children's reported depressive symptoms
Time Frame: Baseline
Measured by Mood and Feelings Questionnaire - Short Version (MFQS). It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 26). Higher scores indicate more severe symptoms.
Baseline
Children's reported depressive symptoms immediately after the intervention
Time Frame: Immediately after the intervention
Measured by Mood and Feelings Questionnaire - Short Version (MFQS). It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 26). Higher scores indicate more severe symptoms.
Immediately after the intervention
Children's reported depressive symptoms at 6 months
Time Frame: 6 months after the intervention
Measured by Mood and Feelings Questionnaire - Short Version (MFQS). It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 26). Higher scores indicate more severe symptoms.
6 months after the intervention
Children's reported depressive symptoms at 12 months
Time Frame: 12 months after the intervention
Measured by Mood and Feelings Questionnaire - Short Version (MFQS). It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 26). Higher scores indicate more severe symptoms.
12 months after the intervention
Baseline parent-reported depressive symptoms
Time Frame: Baseline
Measured by Mood and Feelings Questionnaire Parent-Report (MFQ-P). It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 68). Higher scores indicate more severe symptoms.
Baseline
Parent-reported depressive symptoms immediately after the intervention
Time Frame: Immediately after the intervention
Measured by Mood and Feelings Questionnaire Parent-Report (MFQ-P). It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 68). Higher scores indicate more severe symptoms.
Immediately after the intervention
Parent-reported depressive symptoms immediately at 6 months
Time Frame: 6 months after the intervention
Measured by Mood and Feelings Questionnaire Parent-Report (MFQ-P). It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 68). Higher scores indicate more severe symptoms.
6 months after the intervention
Parent-reported depressive symptoms immediately at 12 months
Time Frame: 12 months after the intervention
Measured by Mood and Feelings Questionnaire Parent-Report (MFQ-P). It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 68). Higher scores indicate more severe symptoms.
12 months after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline children's anxiety-related interference
Time Frame: Baseline
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
Children's anxiety-related interference immediately after the intervention
Time Frame: 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.
Immediately after the intervention
Children's anxiety-related interference at 6 months
Time Frame: 6 months 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.
6 months after the intervention
Children's anxiety-related interference at 12 months
Time Frame: 12 months 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.
12 months after the intervention
Baseline parent-reported anxiety-related interference
Time Frame: Baseline
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
Parent-reported anxiety-related interference immediately after the intervention
Time Frame: 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.
Immediately after the intervention
Parent-reported anxiety-related interference at 6 months
Time Frame: 6 months 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.
6 months after the intervention
Parent-reported anxiety-related interference at 12 months
Time Frame: 12 months 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.
12 months after the intervention
Baseline self-esteem
Time Frame: Baseline
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
Self-esteem immediately after the intervention
Time Frame: 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.
Immediately after the intervention
Self-esteem at 6 months
Time Frame: 6 months 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.
6 months after the intervention
Self-esteem at 12 months
Time Frame: 12 months 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.
12 months after the intervention
Baseline social skills
Time Frame: Baseline
Social Skills Questionnaire (SSQ). It measures children's social functioning, as reflected by specific behavioural responses during interaction with another person. The scale consists of 30 items rated 0 to 2 points. Minimum value 0 and maximum value 60. Higher scores indicate higher social skills.
Baseline
Social skills immediately after the intervention
Time Frame: Immediately after the intervention
Social Skills Questionnaire (SSQ). It measures children's social functioning, as reflected by specific behavioural responses during interaction with another person. The scale consists of 30 items rated 0 to 2 points. Minimum value 0 and maximum value 60. Higher scores indicate higher social skills.
Immediately after the intervention
Social skills at 6 months
Time Frame: 6 months after the intervention
Social Skills Questionnaire (SSQ). It measures children's social functioning, as reflected by specific behavioural responses during interaction with another person. The scale consists of 30 items rated 0 to 2 points. Minimum value 0 and maximum value 60. Higher scores indicate higher social skills.
6 months after the intervention
Social skills at 12 months
Time Frame: 12 months after the intervention
Social Skills Questionnaire (SSQ). It measures children's social functioning, as reflected by specific behavioural responses during interaction with another person. The scale consists of 30 items rated 0 to 2 points. Minimum value 0 and maximum value 60. Higher scores indicate higher social skills.
12 months after the intervention
Baseline social worries
Time Frame: Baseline
Social Worries Questionnaire (SSW). It measures children's social worries, in terms of anxiety about and avoidance of specific social situations in which social evaluation or scrutiny by others is likely to occur. The scale consists of 12 items rated 0 to 2 points. Minimum value 0 and maximum value 24. Higher scores indicate higher social worries.
Baseline
Social worries immediately after the intervention
Time Frame: Immediately after the intervention
Social Worries Questionnaire (SSW). It measures children's social worries, in terms of anxiety about and avoidance of specific social situations in which social evaluation or scrutiny by others is likely to occur. The scale consists of 12 items rated 0 to 2 points. Minimum value 0 and maximum value 24. Higher scores indicate higher social worries.
Immediately after the intervention
Social worries at 6 months
Time Frame: 6 months after the intervention
Social Worries Questionnaire (SSW). It measures children's social worries, in terms of anxiety about and avoidance of specific social situations in which social evaluation or scrutiny by others is likely to occur. The scale consists of 12 items rated 0 to 2 points. Minimum value 0 and maximum value 24. Higher scores indicate higher social worries.
6 months after the intervention
Social worries at 12 months
Time Frame: 12 months after the intervention
Social Worries Questionnaire (SSW). It measures children's social worries, in terms of anxiety about and avoidance of specific social situations in which social evaluation or scrutiny by others is likely to occur. The scale consists of 12 items rated 0 to 2 points. Minimum value 0 and maximum value 24. Higher scores indicate higher social worries.
12 months after the intervention
Baseline cognitive emotion regulation strategies
Time Frame: Baseline
Measured by the Cognitive Emotion Regulation Questionnaire (CERQ-k). CERQ-k consists of 36 items that measure nine cognitive coping strategies. Each subscale represents one cognitive coping strategy: Self-blame, Other blame, Acceptance, Planning, Positive refocusing, Rumination or focus on thought, Positive reappraisal, Putting into perspective, and Catastrophizing. The response format of the items is a five point scale from (almost) never to (almost) always. Each item is rated 1 to 5 points. Minimum value 36 and maximum value 180.
Baseline
Cognitive emotion regulation strategies immediately after the intervention
Time Frame: Immediately after the intervention
Measured by the Cognitive Emotion Regulation Questionnaire children self-report (CERQ-k). CERQ-k consists of 36 items that measure nine cognitive coping strategies. Each subscale represents one cognitive coping strategy: Self-blame, Other blame, Acceptance, Planning, Positive refocusing, Rumination or focus on thought, Positive reappraisal, Putting into perspective, and Catastrophizing. The response format of the items is a five point scale from (almost) never to (almost) always. Each item is rated 1 to 5 points. Minimum value 36 and maximum value 180.
Immediately after the intervention
Cognitive emotion regulation strategies at 6 months
Time Frame: 6 months after the intervention
Measured by the Cognitive Emotion Regulation Questionnaire children self-report (CERQ-k). CERQ-k consists of 36 items that measure nine cognitive coping strategies. Each subscale represents one cognitive coping strategy: Self-blame, Other blame, Acceptance, Planning, Positive refocusing, Rumination or focus on thought, Positive reappraisal, Putting into perspective, and Catastrophizing. The response format of the items is a five point scale from (almost) never to (almost) always. Each item is rated 1 to 5 points. Minimum value 36 and maximum value 180.
6 months after the intervention
Cognitive emotion regulation strategies at 12 months
Time Frame: 12 months after the intervention
Measured by the Cognitive Emotion Regulation Questionnaire children self-report (CERQ-k). CERQ-k consists of 36 items that measure nine cognitive coping strategies. Each subscale represents one cognitive coping strategy: Self-blame, Other blame, Acceptance, Planning, Positive refocusing, Rumination or focus on thought, Positive reappraisal, Putting into perspective, and Catastrophizing. The response format of the items is a five point scale from (almost) never to (almost) always. Each item is rated 1 to 5 points. Minimum value 36 and maximum value 180.
12 months after the intervention
Baseline parental depression, anxiety and stress symptoms
Time Frame: Baseline

Measured by the Depression Anxiety Stress Scales - short version (DASS-21). It contains a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.

Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic nonspecific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.

Baseline
Baseline parental depression, anxiety and stress symptoms
Time Frame: Immediately after the intervention

Measured by the Depression Anxiety Stress Scales - short version (DASS-21). It contains a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.

Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic nonspecific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.

Immediately after the intervention
Baseline parental depression, anxiety and stress symptoms
Time Frame: 6 months after the intervention

Measured by the Depression Anxiety Stress Scales - short version (DASS-21). It contains a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.

Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic nonspecific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.

6 months after the intervention
Baseline parental depression, anxiety and stress symptoms
Time Frame: 12 months after the intervention

Measured by the Depression Anxiety Stress Scales - short version (DASS-21). It contains a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.

Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic nonspecific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.

12 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mireia Orgilés Amorós, Miguel Hernández University of Elche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 6, 2022

First Submitted That Met QC Criteria

October 6, 2022

First Posted (Actual)

October 10, 2022

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 220118115011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD

IPD Sharing Time Frame

Starting after finishing all analysis and publication.

IPD Sharing Access Criteria

Upon request and verification by the principal investigator to consult the available data. The use of the data for distribution in any format is not permitted.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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