Stress hormone, personality and cognition in people who experienced early life stress
| ISRCTN | ISRCTN17890361 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17890361 |
| IRAS number | 316745 |
| Secondary identifying numbers | IRAS 316745 |
- Submission date
- 27/07/2022
- Registration date
- 15/08/2022
- Last edited
- 20/05/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
The purpose of the project is to test the effects of a stress hormone (hydrocortisone) on the stress system (hypothalamic-pituitary-adrenal (HPA axis)) activity by measuring the levels of salivary cortisol secretion of participants with and without adverse experiences in childhood known as early life stress.
We will investigate whether cognitive functions such as attention and memory are affected by hydrocortisone. The research aims to establish the validity and feasibility of an integrative screening test that includes each of these cognitive findings, with adrenal axis findings and hydrocortisone, for a sample of participants with and without early life stress.
Who can participate?
Healthy people aged between 18 and 45 years old and over who do not have current psychiatric disorders
What does the study involve?
All participants should be physically healthy based on a comprehensive medical history and examination. After analysing the data from the first session, the participants will be assigned to either early-life stress or without-early-life stress (control) groups. Participants who meet the inclusion criteria will be eligible to receive either hydrocortisone or a placebo. Each participant will have an equal chance of being assigned to either intervention.
The following assessments will be made before and after the hydrocortisone or placebo tablets as follows:
1. Cognitive assessments
2. Patient Health Questionnaire: screening for depression
3. Screening for posttraumatic stress disorder
4. Maudsley Visual Analogue Scales
5. The Quick Inventory of Depressive Symptomatology
6. A biomarker. An assessment of HPA axis activity will be made by measuring salivary cortisol secretion
What are the possible benefits and risks of participating?
The benefits of taking part are that each participant will receive a copy of the study's final report and, for those who complete the whole study, £100 out-of-pocket expenses. The possible risks of taking part are that some participants may experience side effects with high doses of hydrocortisone such as anxiety, fatigue, fluid retention, headache, hirsutism, and altered mood. For the project under consideration, the hydrocortisone dose is 20 mg twice a day for 3 days only. If a participant becomes confused or raises a concern about their well-being, the participant will be immediately referred to the study supervisors. The supervisor in turn will direct them to the appropriate resources and may decide that such participants should withdraw from the project.
Where is the study run from?
The study will take place in the Centre for Affective Disorders Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King’s College London (United Kingdom)
When is the study starting and how long is it expected to run for?
September 2021 to March 2026
Who is funding the study?
The Centre for Affective Disorders, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London (United Kingdom)
Who is the main contact?
Miss Jawaher Alnassar (United Kingdom)
jawaher.alnassar@kcl.ac.uk
Contact information
Scientific
Institute of Psychiatry, Psychology and Neuroscience (IoPPN)
King’s College London
Room M3.23
PO72 De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom
| Phone | +44 (0)7580057700 |
|---|---|
| jawaher.alnassar@kcl.ac.uk |
Principal Investigator
Institute of Psychiatry, Psychology & Neuroscience (IoPPN)
King's College London
Room E2.09
PO72 De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom
 ORCID ID |
0000-0003-2291-6952 |
|---|---|
| Phone | +44 (0) 20 7848 0088 |
| allan.young@kcl.ac.uk |
Study information
| Study design | Randomized double-blind placebo-controlled crossover design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format |
| Scientific title | Hypothalamic-pituitary-adrenal (HPA) axis function, personality, and cognition in subjects with early life stress |
| Study hypothesis | The study's central hypothesis is that there will be pre-screening, pre-treatment, and post-treatment differences in cognition between participant groups who have either experienced early life stress or did not experience and when administering hydrocortisone to those groups. |
| Ethics approval(s) |
Approved 04/07/2023, London - Camden & Kings Cross Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)2071048083; CamdenandKingsCross.REC@hra.nhs.uk), ref: 23/PR/0513 |
| Condition | Early life stress |
| Intervention | To minimize potential selection bias, we will use a computer random number generator as a randomization technique. The researchers will verify participants' eligibility and randomly assign them during the first experimental session to either the early life stress or no-early life stress (control) groups to receive either an empty opaque placebo gelatine capsule or hydrocortisone (20mg). Both twice a day for 3 consecutive days. After a two-week washout period in the second experimental session, we will repeat the protocol with the opposite intervention to ensure that all patients received either the placebo or hydrocortisone. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Hydrocortisone |
| Primary outcome measure | Screen participants for eligibility: 1. Current mental disorders are measured using a Mini-International Neuropsychiatric Interview (M.I.N.I.) for DSM-5 at baseline 2. Cognitive impairment is measured using the Cognitive Impairment in Psychiatry (SCIP) test at baseline 3. Posttraumatic stress disorder (PTSD) is measured using the PTSD Checklist for DSM-5 at baseline 4. Early life stress is measured using Childhood Trauma Questionnaire at baseline After screening participants' eligibility to enter the trial, they will be assigned to the ‘Early life stress’ and ‘without Early life stress’ groups and undergo further assessments before and after placebo or hydrocortisone administration (at baseline and on day 4): 1. Levels of anxiety measured using Maudsley Visual Analogue Scales 2. Levels of depression measured using the Patient Health Questionnaire and the Quick Inventory of Depressive Symptomatology 3. Spatial Working Memory measured using the Cambridge Neuropsychological Test Automated Battery (CANTAB) 4. The neuropsychological assessments are measured using Cognitive Remediation in Bipolar (CRiB) Battery 5. Salivary levels of HPA axis activity biomarker cortisol measured using ELISA immediately upon awakening, half an hour later, and one hour afterwards |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/09/2021 |
| Overall study end date | 30/03/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Both |
| Target number of participants | Two clusters. 30 participants with early life stress and 30 participants ‘Control’ without early life stress. All participants (n=60) |
| Participant inclusion criteria | Current participant inclusion criteria as of 25/07/2023: 1. Aged 18 to 45 years old 2. Physically healthy Previous participant inclusion criteria: 1. Aged 18 years old and over 2. Physically healthy |
| Participant exclusion criteria | 1. Current DSM-5 psychiatric disorders measured using the Mini-International Neuropsychiatric Interview (M.I.N.I.) at the first experimental session 5. New psychotropic medication or in receipt of any other type of pharmacological or psychological treatment 6. Pregnancy or/and breastfeeding 7. Hormonal medications 8. Any type of allergy |
| Recruitment start date | 10/10/2024 |
| Recruitment end date | 30/01/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Room E2.09
PO72 De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom
Sponsor information
University/education
W1.12
Institute of Psychiatry, Psychology & Neuroscience (IoPPN)
King's College London
De Crespigny Park
London
SE5 8AF
England
United Kingdom
| Phone | +44 (0) 20 7848 0088 |
|---|---|
| slam-ioppn.research@kcl.ac.uk | |
| Website | https://www.kcl.ac.uk/index.aspx |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 30/05/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | 1. Planned publication in a high-impact peer-reviewed scientific journal 2. Conference presentations 3. Part of a PhD thesis |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to privacy and confidentiality. Participants will NOT be identifiable by name in any publication. |
Editorial Notes
20/05/2025: The following changes were made to the trial record:
1. The recruitment start date was changed from 10/10/2022 to 10/10/2024.
2. The recruitment end date was changed from 30/05/2025 to 30/01/2026.
3. The overall end date was changed from 30/10/2025 to 30/03/2026.
08/11/2024: The following changes were made:
1. The overall study end date was changed from 30/10/2024 to 30/10/2025.
2. The recruitment end date was changed from 30/05/2024 to 30/05/2025.
3. The intention to publish date was changed from 30/05/2025 to 30/05/2026.
25/07/2023: The following changes were made to the study record:
1. Ethics approval was added.
2. The inclusion criteria were changed and the plain English summary was updated accordingly.
21/10/2022: The following changes were made to the study record:
1. The recruitment start date
2. The funder was changed from Saudi Arabia Cultural Bureau in London to The Centre for Affective Disorders, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London.
06/09/2022: The sponsor email address has been changed.
15/08/2022: Trial's existence confirmed by Prof Allan Young, Head of School, Academic Psychiatry Director, Centre for Affective Disorders.
