Efficacy of Cognitive Behavioral Therapy and Hair Cortisol Concentration

Study Overview
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Brief Summary
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Stress is considered as a risk factor for physical and mental health. For this reason, interventional programs focused on stress management have been developed. These programs have proven to be efficacious modifying emotional variables and psychopathological symptoms. However, there are no studies showing how these interventions modify objective measures of stress. For example, measures reflecting Hipotalamic-Pituitary-Adrenal (HPA) axis activity, the main system involved in the stress response. The activity of HPA axis is also altered by illness and psychopathology. Hair cortisol technique allows for changes assessment of HPA axis activity during months. Therefore, hair cortisol may be considered as an useful tool to measure changes of emotional variables related to stress in the long term. This measure of change over time of HPA axis activation together with related emotional variables assessment could be useful to evaluate the efficacy of interventional programs. For this reason, the aim of this research is to assess the effects of a cognitive-behavioral treatment (CBT) on perceived stress, resilience, worries, psychopathology and HPA axis activity through hair cortisol analysis.

Official Title
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Hair Cortisol Concentrations as Indicator of Efficacy of Cognitive Behavioral Therapy

Conditions
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Cognitive Therapy, Control

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Member of University of Granada, complete dominance of spanish, high levels of perceived stress. Exclusion Criteria: Psychopathology, being under psychological treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy<br>Cognitive Behavioral Therapy consisting of fourteen weekly group sessions, one hour and a half each, directed by two clinical psychologist. | Behavioral: Cognitive Behavioral Therapy<br>* The intervention consist of 14 weekly group meetings lasting 1.5 or 2 h. Groups are made up of 10 patients. Each group session follow a structured format and consisted of the following elements: introduction to the session, discussion of homework, group discussion and the development of new coping skills. The sessions deal with the following: concept of stress, cognitive restructuring, alternative thought control strategies, relaxation techniques, training in social skills, training in social skills and humour and optimism as coping strategies.<br>|
| No Intervention: Control Group<br>Control Group with no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Connor and Davidson Resilience Scale (CD-RISC) scores. | The scale measures resilience as the ability to successfully cope with stress, punctuations range from 0 to 100, higher scores indicate higher levels of resilience. | Three measures: at the beginning of the study, at three months (when the stress program is finished) and at three months follow up (since the end of the stress program). | 
| Changes of Hair Cortisol Levels | The technique measures hypothalamic-pituitary-adrenal axis activation during the last three months, higher levels indicate higher activation of HPA axis. | Three measures: at the beginning of the study, at three months (when the stress program is finished) and at three months follow up (since the end of the stress program). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in The Cohen Perceived Stress Questionnaire (PSQ) scores. | The questionnaire measures perceived stress during the last month, the punctuations range from 0 to 56, higher scores indicate higher levels of perceived stress. | Three measures: at the beginning of the study, at three months (when the stress program is finished) and at three months follow up (since the end of the stress program). | 
| Changes in The Stress Vulnerability Inventory (SVI) scores. | This Inventory measures the predisposition to be affected by perceived stress, the punctuations range from 0 to 22, higher scores indicate more vulnerability to stress. | Three measures: at the beginning of the study, at three months (when the stress program is finished) and at three months follow up (since the end of the stress program). | 
| Changes in Symptoms Checklist-90-Revised (SCL-90-R) scores. | This scale is a screening tool to measure psychopathological symptoms, it is formed by 9 sub scales (each sub scale refers to one type of psychopathology), all the sub scales scores range from 5 to 99, considering 70 as a clinical punctuation. | Three measures: at the beginning of the study, at three months (when the stress program is finished) and at three months follow up (since the end of the stress program). | 
| Changes in Penn State Worry Questionnaire (PSWQ) scores. | The questionnaire measures the level of permanent worries and the cognitive components of anxiety, the scores range from 16 to 80, higher punctuations indicate higher levels of worries. | Three measures: at the beginning of the study, at three months (when the stress program is finished) and at three months follow up (since the end of the stress program). | 
| Changes in Life Orientation Test Revised (LOT-R) scores. | This test measures dispositional optimism, scores range from 0 to 40, higher punctuations indicate higher levels of optimism. | Three measures: at the beginning of the study, at three months (when the stress program is finished) and at three months follow up (since the end of the stress program). | 
| Changes in Nottingham Health Profile (NHP) scores. | This scale measures perceived state of health, it has 6 sub scales (each corresponds to one health dimension), all the sub scales scores range from 0 to 1, higher punctuations indicates poorer state of health on that dimension. | Three measures: at the beginning of the study, at three months (when the stress program is finished) and at three months follow up (since the end of the stress program). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Behavioral Therapy, Hair Cortisol, Hypothalamic Pituitary Adrenal Axis, Stress, Psychopathology