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Efficacy of Cognitive Behavioral Therapy and Hair Cortisol Concentration

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ClinicalTrials.gov Identifier: NCT03476200
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
María Ángeles García León, Universidad de Granada

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cognitive Therapy Control Behavioral: Cognitive Behavioral Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Hair Cortisol Concentrations as Indicator of Efficacy of Cognitive Behavioral Therapy
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : December 15, 2019


Arm Intervention/treatment
Experimental: Cognitive Behavioral Therapy
Cognitive Behavioral Therapy consisting of fourteen weekly group sessions, one hour and a half each, directed by two clinical psychologist.
Behavioral: Cognitive Behavioral Therapy
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.

No Intervention: Control Group
Control Group with no intervention.



Primary Outcome Measures :
  1. Changes in "Connor and Davidson Resilience Scale" (CD-RISC) scores. [ Time Frame: 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). ]
    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.

  2. Changes of Hair Cortisol Levels [ Time Frame: 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). ]
    The technique measures hypothalamic-pituitary-adrenal axis activation during the last three months, higher levels indicate higher activation of HPA axis.


Secondary Outcome Measures :
  1. Changes in "The Cohen Perceived Stress Questionnaire" (PSQ) scores. [ Time Frame: 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). ]
    The questionnaire measures perceived stress during the last month, the punctuations range from 0 to 56, higher scores indicate higher levels of perceived stress.

  2. Changes in "The Stress Vulnerability Inventory" (SVI) scores. [ Time Frame: 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). ]
    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.

  3. Changes in "Symptoms Checklist-90-Revised" (SCL-90-R) scores. [ Time Frame: 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). ]
    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.

  4. Changes in "Penn State Worry Questionnaire" (PSWQ) scores. [ Time Frame: 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). ]
    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.

  5. Changes in "Life Orientation Test Revised" (LOT-R) scores. [ Time Frame: 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). ]
    This test measures dispositional optimism, scores range from 0 to 40, higher punctuations indicate higher levels of optimism.

  6. Changes in "Nottingham Health Profile" (NHP) scores. [ Time Frame: 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). ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Member of University of Granada, complete dominance of spanish, high levels of perceived stress.

Exclusion Criteria:

  • Psychopathology, being under psychological treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03476200


Contacts
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Contact: María A García-León, MD +34610614698 ext N/D magleon@ugr.es

Locations
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Spain
Department of Personality, Assessment and Psychological Treatment, University of Granada Recruiting
Granada, Spain, 18011
Contact: María A García-León, MD    +34610614698 ext n/d    magleon@gmail.com   
Sponsors and Collaborators
Universidad de Granada
Investigators
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Study Director: Isabel Peralta-Ramírez, Prof Universidad de Granada

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Responsible Party: María Ángeles García León, Principal Investigator, Universidad de Granada
ClinicalTrials.gov Identifier: NCT03476200     History of Changes
Other Study ID Numbers: STR2017
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by María Ángeles García León, Universidad de Granada:
Cognitive Behavioral Therapy
Hair Cortisol
Hypothalamic Pituitary Adrenal Axis
Stress
Psychopathology

Additional relevant MeSH terms:
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Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents