Psychotherapy study to examine whether exposure-based psychotherapy for anxiety disorders is particularly effective when endogenous cortisol levels are high

ISRCTN ISRCTN76072597
DOI https://doi.org/10.1186/ISRCTN76072597
Secondary identifying numbers N/A
Submission date
20/02/2013
Registration date
08/04/2013
Last edited
30/04/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Exposure-based psychotherapy is the gold standard for treating anxiety disorders. Recent research has indicated that the effectiveness of exposure may be increased by cortisol administration before treatment sessions. Cortisol administration may however have unpleasant side effects. Therefore, the current study wants to investigate whether natural variation in endogenous cortisol levels can be used to improve exposure-based psychotherapy.
Our physiological status differs a lot from morning to evening. For example the cortisol level is high in the morning and than declines during the day with low levels in the evening/night. In our study we want to examine whether the endogenous variations in diurnal cortisol levels are also able to modulate therapy outcome. That is why we expect therapy in the morning (when cortisol levels are high) to have a better outcome than therapy in the evening (when endogenous cortisol levels are low). The two groups will receive the same treatment, but are randomly allocated to receiving this treatment either at 8am or at 6pm.

Who can participate?
We wish to treat 60 patients with spider phobia. Participation is restricted to physically healthy, non smoking women who use oral contraceptives and who have a body mass index between 20 and 25.

What does the study involve?
Participants will receive state of the art psychotherapy treatment for spider phobia. Participants will need to come for two sessions. In the first session, it will be determined if participants fulfil diagnostic criteria for spider phobia and meet criteria for study participation. The treatment is also explained in detail. The second session is the real treatment session. It will last approximately three hours and will involve confrontation with living spiders. Participants will also be required to fill in a number of questionnaires and to give saliva samples and a strand of hair so that we can measure endogenous cortisol levels. One week and three months after the treatment session, participants come back for a behavioural approach task, which examines how close they can get to a live spider.

What are the possible risks and benefits of patients?
The study involves no risks and most participants will benefit from it. The treatment manual is well-established and known to be highly effective. People with low endogenous cortisol levels may, however, profit a little bit less than people with high cortisol levels.

Where is the study run from?
The study is run at the Saarland University (Germany). It is conducted by the Department of Psychology, Division of Clinical Psychology and Psychotherapy.

When is study starting and how long is it expected to run for?
The study started in Summer 2011 and will end when 60 patients have been treated.

Who is funding the study?
The study is exclusively funded by the Saarland University.

Who is the main contact?
Prof. Dr. Tanja Michael
t.michael@mx.uni-saarland.de

Contact information

Prof Tanja Michael
Scientific

Saarland University
Dept. of Psychology
Division of Clinical Psychology and Psychotherapy
Saarbruecken
66123
Germany

Email t.michael@mx.uni-saarland.de

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRandomised controlled trial to determine whether the effectiveness of exposure-based psychotherapy for specific phobia is influenced by endogenous cortisol levels
Study objectivesPatients with high endogenous levels of cortisol profit more from treatment than patients with low endogenous levels of cortisol
Ethics approval(s)Ethical committee of the medical association of Saarland was provided on March 17 th 2011
Health condition(s) or problem(s) studiedSpecific Phobia (Spider Phobia) / Psychotherapy
InterventionComparing two treatment conditions for spider phobia.

Participants underwent a one session (three hour) exposure therapy treatment. Participants were gradually exposed to different living spiders of increasing sizes and cognitions about spiders were challenged during treatment.

The therapy session consisted of several exposure steps with increasing complexity. The therapist first demonstrated each exposure task to the patient and then asked the patient to carry out the task. Each task was repeated till a marked anxiety reduction occurred. The first step was to catch the smallest spider with a glass and a postcard. After this task was accomplished with a low anxiety level the patient was asked to touch the spider with his index finger. The third step was to let the spider walk on the patient’s hand. After this, the therapists instructed the patient to let the spider walk on her body. The above four steps were then repeated with another 2 spiders of gradually larger size, the largest being about 5 cm (with legs).)

The two treatment conditions differed solely in the time of interventions. Treatments in the first group were conducted at 08.00 a.m. in the morning, treatments in the second group were conducted at 06.00 p.m. in the evening. Participation included four appointments: an initial screening session to clarify study eligibility and to assess symptoms before treatment (pretreatment assessment), one three-hour-treatment session (either at 08.00 a.m. in the morning or at 06.00 p.m. in the evening), an assessment one week after the treatment session (posttreatment assessment), and a follow-up assessment 12-14 weeks after the treatment session (follow-up assessment).
Intervention typeOther
Primary outcome measureBehavioural Approach Test (BAT): To test the patients’ fear and avoidance of living spiders participants are asked to approach a living house spider that is placed in a sealed container. The patient’s behaviour is rated on a scale from 0 to 12, where 0: refusal to enter the room and 12: holding the spider for at least 20 seconds.

Measured at baseline (prior to treatment), one week after treatment, and three months (12-14 weeks after treatment).
Secondary outcome measuresFear of Spider Questionnaire (FSQ): The FSQ is a self-report questionnaire designed to measure spider phobia. It consists of 18 items that refer to a restricted time period and are rated on a seven point scale.

Measured at baseline (prior to treatment), one week after treatment, and three months (12-14 weeks after treatment).
Overall study start date01/06/2011
Completion date31/05/2012

Eligibility

Participant type(s)Patient
Age groupNot Specified
Lower age limit18 Years
Upper age limit60 Years
SexFemale
Target number of participantsSixty
Key inclusion criteriaParticipation is restricted to:
1. Healthy, non-smoking women, aged 18-60
2. Using oral contraceptives
3. Body mass index between 20-25 mg²
Key exclusion criteria1. Recent history of systemic or oral cortisol therapy
2. Any axis I disorder (other than spider phobia)
3. Severe acute or chronic disease (e.g. lung or heart diseases)
4. Allergic reactions to insect bites
5. Pregnancy and lactating
5. Current pharmacological treatment or psychotherapy
6. We also require patients to refrain from physical exercise, alcohol and caffeinated drinks within 3 hours prior to therapy
Date of first enrolment01/06/2011
Date of final enrolment31/05/2012

Locations

Countries of recruitment

  • Germany

Study participating centre

Saarland University
Saarbruecken
66123
Germany

Sponsor information

University of Saarland (Germany)
University/education

Universität des Saarlandes
Campus
D-66123 Saarbrücken
Saarbruecken
66123
Germany

Website http://www.uni-saarland.de/
ROR logo "ROR" https://ror.org/01jdpyv68

Funders

Funder type

University/education

Saarland University (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan