Efficacy of Cognitive Behavioral Therapy and Hair Cortisol Concentration

NCT03476200 | Completed

• 1 other identifier: STR2017
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Therapy; Control

Keywords

Cognitive Behavioral Therapy; Hair Cortisol; Hypothalamic Pituitary Adrenal Axis; Stress; Psychopathology

Outcome Measures

Primary Outcomes (2)

• 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).

• 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 Outcomes (6)

• 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).

• 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).

• 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).

• 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).

• 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).

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL

Cognitive Behavioral Therapy consisting of fourteen weekly group sessions, one hour and a half each, directed by two clinical psychologist.

Behavioral: Cognitive Behavioral Therapy

Control Group

NO INTERVENTION

Control Group with no intervention.

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

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.

Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Psychopathology, being under psychological treatment.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Department of Personality, Assessment and Psychological Treatment, University of Granada

Granada, 18011, Spain

Location

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Isabel Peralta-Ramírez, Prof

  Universidad de Granada

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2018
• First Posted: March 23, 2018
• Study Start: February 1, 2017
• Primary Completion: September 15, 2018
• Study Completion: December 15, 2018
• Last Updated: July 20, 2021

Record last verified: 2021-07

Locations

ES (1)