Protocol summary
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Study aim
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the effect of Transdiagnostic Cognitive Behavior therapy on Emotion Regulation, Repetitive Negative Thought, Social Adjusting in Adolescents With Sub-clinical Diagnostic of Emotional Disorders.
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Design
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A randomized controlled trial will use the Excel software rand function for randomization.
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Settings and conduct
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The intervention is individual and will be done in 12 sessions online. The length of the sessions will be 45 minutes. The evaluator and therapist of the project will be an individual who will perform the protocol modalities according to the protocol as well as the number of sessions designated for each modal.
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Participants/Inclusion and exclusion criteria
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Entry criteria: Presence of sub-clinical symptoms, Age range 12 to 17 years, No severe psychiatric disorders, Abstinence from drugs and alcohol in the last three months,Failure to receive cognitive-behavioral interventions, Failure to receive medication, Participants' interest in participating in the research, No chronic medical illness
Exist criteria : Receiving other similar psychological interventions, Medication at the same time as the intervention
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Intervention groups
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12 45-minute treatment sessions will be performed for the members of the intervention group. The main focus of the sessions is on cognitive reconstruction, awareness of bodily senses, awareness of the moment, teaching the concepts of contrasting behavior, and the three components of emotion that include thoughts, bodily senses, and behavior. Members of the control group will also not receive any intervention. They will be evaluated in only three periods.
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Main outcome variables
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ٍEmotion regulation, Repetitive Negative Thoughts, Social adjustment, Preclinical symptoms of anxiety and depression.
General information
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Reason for update
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Add two new secondary variables to the Clinical trial
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210428051113N1
Registration date:
2021-06-14, 1400/03/24
Registration timing:
prospective
Last update:
2021-10-23, 1400/08/01
Update count:
1
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Registration date
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2021-06-14, 1400/03/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-06-29, 1400/04/08
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Expected recruitment end date
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2021-08-30, 1400/06/08
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Efficacy of Transdiagnostic Cognitive Behavior therapy on Emotion Regulation, Repetitive Negative Thought, Social Adjusting in Adolescents With Sub-clinical Diagnostic of Emotional Disorders
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Public title
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The Effect of Cognitive Behavior therapy on Emotion Control, Repetitive Annoying Thought, Adjusting in Adolescents With Mild to moderate Symptoms of Anxiety and Depression
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Presence of sub-clinical symptoms of anxiety and depression
Age range 12 to 17 years
Participants' interest in participating in the research on the provisions of written consent
Exclusion criteria:
Existence of drug or alcohol addiction
Existence of chronic medical disease
Having severe psychiatric disorders(psychotic spectrum, bipolar disorders)
Receive medication one month before starting treatment
Receive cognitive-behavioral interventions for at least 8 sessions in the last 5 years
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Age
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From 12 years old to 17 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will be done using Excel software. halve the number of participants and enter in tow columns 1 and 2. in the second column, we generate a random number using the Rand function option; then we sort the data by their values(ascending or descending). according to the order of numbers 1 and 2, the samples are randomly assigned to two groups.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Other
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-05-27, 1400/03/06
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Ethics committee reference number
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IR.ZUMS.REC.1400.053
Health conditions studied
1
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Description of health condition studied
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Major depressive disorder, single episode
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ICD-10 code
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F32
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ICD-10 code description
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Major depressive disorder, single episode
2
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Description of health condition studied
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Major depressive disorder, recurrent
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ICD-10 code
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F33
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ICD-10 code description
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Major depressive disorder, recurrent
3
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Description of health condition studied
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Persistent mood [affective] disorders
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ICD-10 code
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F34
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ICD-10 code description
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Persistent mood [affective] disorders
4
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Description of health condition studied
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Social phobias
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ICD-10 code
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F40.1
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ICD-10 code description
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Social phobias
5
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Description of health condition studied
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Panic disorder
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ICD-10 code
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F41.0
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ICD-10 code description
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Panic disorder [episodic paroxysmal anxiety] without agoraphobia
6
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Description of health condition studied
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Generalized anxiety disorder
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ICD-10 code
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F41.1
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ICD-10 code description
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Generalized anxiety disorder
7
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Description of health condition studied
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Other mixed anxiety disorders
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ICD-10 code
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F41.3
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ICD-10 code description
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Other mixed anxiety disorders
8
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Description of health condition studied
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Mixed anxiety and depressive disorder
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ICD-10 code
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F41.2
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ICD-10 code description
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Mixed anxiety and depressive disorder
Primary outcomes
1
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Description
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Sub-clinical symptoms of anxiety and depression mean that the necessary criteria for depressive or anxiety disorders are not met, and only symptoms of anxiety and depression that are in the mild to moderate range.
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Timepoint
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Measurements will be performed in three periods one period before the start of the intervention, 7 days later and 3 months later.
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Method of measurement
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For the anxiety and depression variable, the 21 _DASS questionnaire will be used. The subject's score in the range of 14-18 for anxiety and 10 to 20 for depression indicates the presence of sub-clinical symptoms of anxiety and depression.
2
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Description
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Emotion regulation, which means the ability to reduce, increase or modify emotions.
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Timepoint
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Measurements will be performed in three periods one period before the start of the intervention, 7 days later and 3 months later.
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Method of measurement
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The Cognitive Emotion Regulation Questionnaire (CERQ) will be used to measure emotion regulation. This questionnaire has 36 items.
3
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Description
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Repetitive negative thoughts whose main characteristic is repetitive, annoying and unwanted.
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Timepoint
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Measurements will be performed in three periods one period before the start of the intervention, 7 days later and 3 months later.
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Method of measurement
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A negative recurring thoughts questionnaire (RTQ_10) will be used to measure this variable. This questionnaire has 10 items.
4
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Description
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Social adjustment means the ability to adapt and compromise with oneself, the environment and others.
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Timepoint
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Measurements will be performed in three periods one period before the start of the intervention, 7 days later and 3 months later.
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Method of measurement
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The Bell Social Adjustment Questionnaire will be used to measure this variable. This questionnaire has 32 items.
Secondary outcomes
1
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Description
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Cognitive Flexibility
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Timepoint
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Before the intervention, 14 days and 3 months after the intervention
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Method of measurement
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Questionnaire of psychological flexibility or acceptance of action with 7 questions (AAQ) Acceptance and Action Questionnaire
2
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Description
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Stress Vulnerability
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Timepoint
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Before the intervention, 14 days and 3 months after the intervention
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Method of measurement
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7 Stress Questions Out of 21 questions in the Depression, Anxiety and Stress Questionnaire (DASS)
Intervention groups
1
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Description
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Intervention group: The intervention group will be implemented based on an integrated transdiagnostic treatment protocol for adolescents. This protocol has 8 modals that will be implemented in 12 sessions. Protocol modalities include 1) Motivating and maintaining it 2) Identifying emotions and behaviors 3) Introducing emotion-focused behavioral experiments 4) Awareness of bodily senses 5) Flexibility in thinking 6) Awareness of emotional experiences 7) Facing situational emotions 8) Review skills and progress towards goals and maintain achievements. The main focus of the protocol is on emotion and its three basic components, namely thoughts, body senses and behavior. In the thought component, the focus on teaching mental errors is cognitive reconstruction. In the component of bodily senses, techniques of awareness of bodily senses are performed. In the behavior component, the concepts of driver and contrasting behavior are taught. Finally, situational emotion coping techniques and behavioral experiments will be performed. The modals will run for 8 sessions of 45 minutes for approximately 5 weeks. Depending on the age of the client and his / her understanding of the concepts and problems related to preclinical symptoms of emotional disorder that are unique to each client, these modals will be distributed in the sessions and the participation of parents will be determined if necessary.
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Category
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Treatment - Other
2
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Description
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Control group: Members of the control group will be evaluated in three periods without receiving any intervention. During this time, they should not seek psychological treatment or medication for their symptoms. The evaluation period for the members of this group lasted four months according to the quarterly follow-up period.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Zanjan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available