Clinical trial NCT03476200: Efficacy of Cognitive Behavioral Therapy and Hair Cortisol Concentration
Official title: Hair Cortisol Concentrations as Indicator of Efficacy of Cognitive Behavioral Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Therapy
Control
Keywords: Cognitive Behavioral Therapy
Hair Cortisol
Hypothalamic Pituitary Adrenal Axis
Stress
Psychopathology
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Psychopathology, being under psychological treatment.

Primary outcomes:
measure: Changes in "Connor and Davidson Resilience Scale" (CD-RISC) scores.
timeFrame: 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).
measure: Changes of Hair Cortisol Levels
timeFrame: 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 outcomes:
measure: Changes in "The Cohen Perceived Stress Questionnaire" (PSQ) scores.
timeFrame: 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).
measure: Changes in "The Stress Vulnerability Inventory" (SVI) scores.
timeFrame: 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).
measure: Changes in "Symptoms Checklist-90-Revised" (SCL-90-R) scores.
timeFrame: 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).
measure: Changes in "Penn State Worry Questionnaire" (PSWQ) scores.
timeFrame: 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).
measure: Changes in "Life Orientation Test Revised" (LOT-R) scores.
timeFrame: 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).
measure: Changes in "Nottingham Health Profile" (NHP) scores.
timeFrame: 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).
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Department of Personality, Assessment and Psychological Treatment, University of Granada
Study officials:
affiliation: Universidad de Granada
name: Isabel Peralta-Ramírez, Prof
role: STUDY_DIRECTOR
References: