Complex Post-Traumatic Stress DisorderNCT06464432
Complex-Posttraumatic Stress Disorder in Urban Egypt: Pilot Testing of a Culturally-adapted Evidence-Based Treatment Manual and Development of a Culture-specific Diagnostic
A study testing Enhanced Skills Training in Affective and Interpersonal Regulation in people with Complex Post-Traumatic Stress Disorder, run by University of Lausanne at 1 site in Egypt.
Trial summary
Background: The CPTSD diagnosis presented in the ICD-11 is supposed to provide core and culturally invariant symptoms, which is supported by recent research. Yet, evidence also shows the necessity of integrating culture-specific symptoms in intervention and diagnostic tools to enhance the validity and efficacy of such… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Post-Traumatic Stress Disorder
- What is being tested?
- Enhanced Skills Training in Affective and Interpersonal Regulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 1 Mar 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Egyptian
- 18 years of age or older
- Literate, can give written or oral consent
- History of severe and/or prolonged trauma, and screen positive for CPTSD
- Reside in any other major city
Who cannot join
- Imminent risk of suicide, psychotic symptoms, and/or severe alcohol and/or drug abuse
- Have been in therapy before (i.e., completed more than 5-10 sessions of psychotherapy)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
The American University in Cairo
Cairo, 11835
Nadine Hosny, MSc, +201005557273, nadine.hosny@unil.ch
Kate Ellis, PhD, 0020 2615 1817, kate.ellis@aucegypt.edu
About this study
Background: The CPTSD diagnosis presented in the ICD-11 is supposed to provide core and culturally invariant symptoms, which is supported by recent research. Yet, evidence also shows the necessity of integrating culture-specific symptoms in intervention and diagnostic tools to enhance the validity and efficacy of such diagnoses and therapeutic interventions. Along with cultural aspects, there are relevant structural aspects e.g., economic, and social inequalities, which impact mental health. These aspects remain understudied in low middle income countries like Egypt, where there are considerable rates of violence.
Aims: The project aims to i) culturally adapt and pilot test the therapeutic manual ESTAIR/MPE in urban Egypt, and ii) to pilot test a cultural and structural module for the diagnostic assessment of CPTSD among the same target population. The objective is to assess the feasibility, acceptability, and initial impact on clinical outcomes of both the manual and diagnostic modules.
Methods: In earlier phases, the project gathered qualitative data from key informants on the cultural and structural dimensions of CPTSD in urban Egypt. Using the collected data, investigators culturally adapted this intervention and developed a diagnostic cultural module. Subsequently, the investigators will pilot-test it in four groups of five participants each, 20 participants in total. The project intends to collect both quantitative and qualitative measures to explore determined outcomes and analyze them accordingly.
Read the detailed description
For further information, please see the attached protocol.
- Conditions
- Complex Post-Traumatic Stress Disorder
- Being tested
- Enhanced Skills Training in Affective and Interpersonal Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Skills Training in Affective and Interpersonal RegulationBehavioural
Enhanced Skills Training in Affective and Interpersonal Regulation combined with Modified Prolonged Exposure (ESTAIR); Psychotherapeutic manual for the treatment of Complex Post-Traumatic Stress Disorder (CPTSD) consisting of 4 therapeutic modules: 1. Emotion Regulation, 2, Self-concept, 3. Relationship Patterns, 4. Prolonged Exposure.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: ESTAIR Psychotherapeutic Manual | Experimental | Not described Receives: Behavioral: Enhanced Skills Training in Affective and Interpersonal Regulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility ESTAIR Manual
We will primarily assess feasibility by determining the percentage of participants who complete the study until the end (among those who sign the informed consent). Based on reported dropout rates from studies using similar modular interventions with trauma survivors, we will consider 80-90% participation and adherence as excellent, 70-80% as satisfactory, and 60-70% as acceptable.
Measured: 7 months
Acceptability ESTAIR Manual
We will assess the acceptability by conducting feedback qualitative interviews after each module and overall feedback on therapy process at the end of therapy.
Measured: 7 months
Feasibility of ITI-Cultural Module
We will assess the ITI feasibility, using the same method based on the percentage of participants who complete the ITI; 80-90% participation and adherence is considered as excellent, 70-80% as satisfactory, and 60-70% as acceptable.
Measured: 7 months
Acceptability of ITI-Cultural Module
We will assess the acceptability of the ITI through qualitative interviews after the diagnostic interview.
Measured: 7 months
Secondary outcomes (5)
Complex post-traumatic stress disorder
The International Trauma Questionnaire asses 12 symptoms (6 for post-traumatic stress disorder and another 6 for disturbances in self-organisation). A diagnosis of CPTSD requires the endorsement of at least one of the two symptoms from each of the three PTSD symptom clusters described above (i.e., re-experiencing in the here and now, avoidance, and sense of current threat) and at least one of the two symptoms from each of the three Disturbances in Self-Organisation (DSO) clusters (i.e. affective dysregulation, negative self-concept, and disturbances in relationships). Items are scored on a Likert scale ranging from 0 (not at all) to 4 (extremely).
The endorsement of a symptom item is defined as a score ≥ 2.
Measured: 7 months
Depression
Patient Health Questionnaire (PHQ-9). The PHQ-9 score may range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day). Higher scores mean higher levels of depression.
Measured: 7 months
Anxiety
General Anxiety Disorder Questionnaire (GAD-7). The GAD-7 score may range from 0 to 21, since each of the 7 items can be scored from 0 (not at all) to 3 (nearly every day). Higher scores mean higher levels of anxiety.
Measured: 7 months
Somatic Symptoms
Somatic Symptoms Scale (SSS-8). The SSS-8 score may range from 0 to 32, since each of the 8 items can be scored from 0 (not at all) to 4 (severely). Higher scores mean higher levels of somatic symptoms.
Measured: 7 months
Well-being
WHO-5 questionnaire. Scores range from 0-25, based on a Likert scale from 0 (not at all) to 5 (all of the time) for each item. Higher scores reflect better levels of well-being.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 Aug 2024 (estimated)
- Primary completion15 Feb 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Post-Traumatic Stress DisorderStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Un-randomized Pilot
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Collaborators
- The American University in Cairo
- Responsible party
- Principal investigator, Nadine Hosny, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464432
- Sponsor's protocol ID
- 052024_00001
- Other IDs
- 2023-2024-204
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 20 Jun 2024
- 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 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex-Posttraumatic Stress Disorder in Urban Egypt: Pilot Testing of a Culturally-adapted Evidence-Based Treatment Manual and Development of a Culture-specific Diagnostic
- ClinicalTrials.gov ID
- NCT06464432
- Acronym / sponsor ID
- 052024_00001
- Conditions
- Complex Post-Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Collaborators
- The American University in Cairo
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 18 Jun 2024 (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.
Background: The CPTSD diagnosis presented in the ICD-11 is supposed to provide core and culturally invariant symptoms, which is supported by recent research. Yet, evidence also shows the necessity of integrating culture-specific symptoms in intervention and diagnostic tools to enhance the validity and efficacy of such diagnoses and therapeutic interventions. Along with cultural aspects, there are relevant structural aspects e.g., economic, and social inequalities, which impact mental health. These aspects remain understudied in low middle income countries like Egypt, where there are considerable rates of violence.
Aims: The project aims to i) culturally adapt and pilot test the therapeutic manual ESTAIR/MPE in urban Egypt, and ii) to pilot test a cultural and structural module for the diagnostic assessment of CPTSD among the same target population. The objective is to assess the feasibility, acceptability, and initial impact on clinical outcomes of both the manual and diagnostic modules.
Methods: In earlier phases, the project gathered qualitative data from key informants on the cultural and structural dimensions of CPTSD in urban Egypt. Using the collected data, investigators culturally adapted this intervention and developed a diagnostic cultural module. Subsequently, the investigators will pilot-test it in four groups of five participants each, 20 participants in total. The project intends to collect both quantitative and qualitative measures to explore determined outcomes and analyze them accordingly.
Detailed description
For further information, please see the attached protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Un-randomized Pilot
| Arm | Type | Receives |
|---|---|---|
| Intervention: ESTAIR Psychotherapeutic Manual | Experimental | Behavioral: Enhanced Skills Training in Affective and Interpersonal Regulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Egyptian
- 18 years of age or older
- Literate, can give written or oral consent
- History of severe and/or prolonged trauma, and screen positive for CPTSD
- Reside in any other major city
Key exclusion criteria (2 listed)
- Imminent risk of suicide, psychotic symptoms, and/or severe alcohol and/or drug abuse
- Have been in therapy before (i.e., completed more than 5-10 sessions of psychotherapy)
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 |
|---|---|---|
| Enhanced Skills Training in Affective and Interpersonal RegulationEnhanced Skills Training in Affective and Interpersonal Regulation combined with Modified Prolonged Exposure (ESTAIR); Psychotherapeutic manual for the treatment of Complex Post-Traumatic Stress Disorder (CPTSD) consisting of 4 therapeutic modules: 1. Emotion Regulation, 2, Self-concept, 3. Relationship Patterns, 4. Prolonged Exposure. | Behavioural | Intervention: ESTAIR Psychotherapeutic Manual |
Primary outcome
Feasibility ESTAIR Manual
Time frame: 7 months
We will primarily assess feasibility by determining the percentage of participants who complete the study until the end (among those who sign the informed consent). Based on reported dropout rates from studies using similar modular interventions with trauma survivors, we will consider 80-90% participation and adherence as excellent, 70-80% as satisfactory, and 60-70% as acceptable.
Acceptability ESTAIR Manual
Time frame: 7 months
We will assess the acceptability by conducting feedback qualitative interviews after each module and overall feedback on therapy process at the end of therapy.
Feasibility of ITI-Cultural Module
Time frame: 7 months
We will assess the ITI feasibility, using the same method based on the percentage of participants who complete the ITI; 80-90% participation and adherence is considered as excellent, 70-80% as satisfactory, and 60-70% as acceptable.
Acceptability of ITI-Cultural Module
Time frame: 7 months
We will assess the acceptability of the ITI through qualitative interviews after the diagnostic interview.
5 secondary outcomes
Complex post-traumatic stress disorder
Time frame: 7 months
Depression
Time frame: 7 months
Anxiety
Time frame: 7 months
Somatic Symptoms
Time frame: 7 months
Well-being
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Skills Training in Affective and Interpersonal Regulation in people with Complex Post-Traumatic Stress Disorder, run by University of Lausanne at 1 site in Egypt.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Jun 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadine Hosny, MSc (+41766380067, nadine.hosny@unil.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility ESTAIR Manual (time frame: 7 months). The study lists 4 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 Jun 2024.