Efficacy of Cognitive Behavioral Therapy and Hair Cortisol Concentration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-12-15

Brief Summary

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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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Detailed Description

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Conditions

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Cognitive Therapy Control

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cognitive Behavioral Therapy

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

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type 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.

Control Group

Control Group with no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL