Efficacy of Cognitive Behavioral Therapy and Hair Cortisol Concentration

Sponsor
Universidad de Granada (Other)
Overall Status
Completed
CT.gov ID
NCT03476200
Collaborator
(none)
83
1
2
22.4
3.7

Study Details

Study Description

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
  • Behavioral: Cognitive Behavioral Therapy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
83 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 :
Feb 1, 2017
Actual Primary Completion Date :
Sep 15, 2018
Actual Study Completion Date :
Dec 15, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Member of University of Granada, complete dominance of spanish, high levels of perceived stress.
Exclusion Criteria:
  • Psychopathology, being under psychological treatment.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Personality, Assessment and Psychological Treatment, University of Granada Granada Spain 18011

Sponsors and Collaborators

  • Universidad de Granada

Investigators

  • Study Director: Isabel Peralta-Ramírez, Prof, Universidad de Granada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
María Ángeles García León, Principal Investigator, Universidad de Granada
ClinicalTrials.gov Identifier:
NCT03476200
Other Study ID Numbers:
  • STR2017
First Posted:
Mar 23, 2018
Last Update Posted:
Jul 20, 2021
Last Verified:
Jul 1, 2021
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, Principal Investigator, Universidad de Granada

Study Results

No Results Posted as of Jul 20, 2021