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Completed

NCT Number: NCT03476200

Efficacy of Cognitive Behavioral Therapy and Hair Cortisol Concentration

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.

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Key information

Conditions

Cognitive Therapy Control

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Granada, 18011, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Psychopathology, being under psychological treatment.

Treatment and study plan

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.

Primary outcomes

  1. Changes in "Connor and Davidson Resilience Scale" (CD-RISC) scores.

    Time frame: 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

    Time frame: 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 outcomes

  1. Changes in "The Cohen Perceived Stress Questionnaire" (PSQ) scores.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

Hair Cortisol Concentrations as Indicator of Efficacy of Cognitive Behavioral Therapy

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 23, 2018
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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