Cognitive TherapyNCT03476200
Efficacy of Cognitive Behavioral Therapy and Hair Cortisol Concentration
A study testing Cognitive Behavioral Therapy in people with Cognitive Therapy and Control, run by Universidad de Granada at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Therapy, Control
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2017to 15 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Member of University of Granada, complete dominance of spanish, high levels of perceived stress.
Who cannot join
- Psychopathology, being under psychological treatment.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Personality, Assessment and Psychological Treatment, University of Granada
Granada, 18011
About this study
Official title: Hair Cortisol Concentrations as Indicator of Efficacy of Cognitive Behavioral Therapy
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
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- Cognitive Behavioral Therapy, Hair Cortisol, Hypothalamic Pituitary Adrenal Axis, Stress, Psychopathology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Cognitive Behavioral Therapy consisting of fourteen weekly group sessions, one hour and a half each, directed by two clinical psychologist. Receives: Behavioral: Cognitive Behavioral Therapy |
| Control Group | No intervention | Control Group with no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
The questionnaire measures perceived stress during the last month, the punctuations range from 0 to 56, higher scores indicate higher levels of perceived stress.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
This test measures dispositional optimism, scores range from 0 to 40, higher punctuations indicate higher levels of optimism.
Measured: 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 "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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start1 Feb 2017
- Primary completion15 Sep 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Ángeles García León, Universidad de Granada
- Investigators
- Isabel Peralta-Ramírez, Prof, Study director, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476200
- Sponsor's protocol ID
- STR2017
- Status last verified
- Jul 2021
- First submitted
- 11 Mar 2018
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hair Cortisol Concentrations as Indicator of Efficacy of Cognitive Behavioral Therapy
- ClinicalTrials.gov ID
- NCT03476200
- Acronym / sponsor ID
- STR2017
- Conditions
- Cognitive Therapy, Control
- Keywords
- Cognitive Behavioral Therapy, Hair Cortisol, Hypothalamic Pituitary Adrenal Axis, Stress, Psychopathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral TherapyCognitive Behavioral Therapy consisting of fourteen weekly group sessions, one hour and a half each, directed by two clinical psychologist. |
| Control Group | No intervention | –Control Group with no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Member of University of Granada, complete dominance of spanish, high levels of perceived stress.
Key exclusion criteria (1 listed)
- Psychopathology, being under psychological treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyThe 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. | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
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.
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.
6 secondary outcomes
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).
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).
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).
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabel Peralta-Ramírez, Prof study director
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Cognitive Therapy and Control, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.