Efficacy of Cognitive Behavioral Therapy and Hair Cortisol Concentration

Control Clinical Trial

Official title:

Hair Cortisol Concentrations as Indicator of Efficacy of Cognitive Behavioral Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03476200
• Other study ID #: STR2017
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: December 15, 2018

Study information

• Verified date: July 2021
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 15, 2018
• Est. primary completion date: September 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Psychopathology, being under psychological treatment.

Related Conditions & MeSH terms

• Cognitive Therapy
• Control

Intervention

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.

Locations

Country	Name	City	State
Spain	Department of Personality, Assessment and Psychological Treatment, University of Granada	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).