Efficacy of Cognitive Behavioral Therapy and Hair Cortisol Concentration
- Conditions
- ControlCognitive Therapy
- Interventions
- Behavioral: Cognitive Behavioral Therapy
- Registration Number
- NCT03476200
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
- Member of University of Granada, complete dominance of spanish, high levels of perceived stress.
- Psychopathology, being under psychological treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive Behavioral Therapy Cognitive Behavioral Therapy Cognitive Behavioral Therapy consisting of fourteen weekly group sessions, one hour and a half each, directed by two clinical psychologist.
- Primary Outcome Measures
Name Time Method Changes of Hair Cortisol Levels 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.
Changes in "Connor and Davidson Resilience Scale" (CD-RISC) scores. 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.
- Secondary Outcome Measures
Name Time Method Changes in "Nottingham Health Profile" (NHP) scores. 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.
Changes in "Symptoms Checklist-90-Revised" (SCL-90-R) scores. 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.
Changes in "The Cohen Perceived Stress Questionnaire" (PSQ) scores. 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.
Changes in "The Stress Vulnerability Inventory" (SVI) scores. 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.
Changes in "Penn State Worry Questionnaire" (PSWQ) scores. 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.
Changes in "Life Orientation Test Revised" (LOT-R) scores. 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.
Trial Locations
- Locations (1)
Department of Personality, Assessment and Psychological Treatment, University of Granada
🇪🇸Granada, Spain