Suicidal IdeationNCT06825351
A Feasibility Study of Psychological First Aid Versus Dialectal Behavioral Intervention in Undergraduate Students With Suicide Risk: A Comparative Crossover Randomized ControlledTrial
A study testing Psychological First Aid versus Dialectal behavioral Intervention in people with Suicidal Ideation, run by Alexandria University at 1 site in Egypt.
Trial summary
his feasibility study aims to compare the effectiveness of Psychological First Aid (PFA) and Dialectical Behavior Therapy (DBT) interventions in reducing suicide risk among undergraduate students. Read more about this study
- Who is it for?
- Ages 18 to 27 years
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Psychological First Aid versus Dialectal behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 27 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants in this feasibility study must be undergraduate students aged 18-25 years who are identified as at risk for suicide based on a validated screening tool. They must be currently enrolled in a degree program, able to provide informed consent, and proficient in English.
Who cannot join
- Individuals with severe mental illnesses (e.g., schizophrenia, bipolar disorder), those in acute crisis requiring immediate intervention, current substance abuse issues, significant cognitive impairments, prior experience with DBT or similar therapies within the last year, and physical health conditions that could complicate participation.
Trial locations and contacts
1 site in 1 country.
About this study
his feasibility study aims to compare the effectiveness of Psychological First Aid (PFA) and Dialectical Behavior Therapy (DBT) interventions in reducing suicide risk among undergraduate students. The study employs a crossover randomized controlled trial design, allowing participants to experience both interventions at different times.
Read the detailed description
Suicide risk among undergraduate students is a pressing mental health concern, exacerbated by academic pressures and social isolation. Psychological First Aid (PFA) is a supportive intervention designed to reduce distress and foster coping in the immediate aftermath of a crisis. Conversely, Dialectical Behavior Therapy (DBT) is a structured, evidence-based therapy that focuses on emotional regulation, interpersonal effectiveness, and distress tolerance. This study explores the feasibility and effectiveness of these two interventions in a university setting.
- Conditions
- Suicidal Ideation
- Being tested
- Psychological First Aid versus Dialectal behavioral Intervention
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological First Aid versus Dialectal behavioral InterventionBehavioural
PFA is an immediate, supportive intervention aimed at helping individuals in distress. It focuses on providing emotional support and practical assistance in the aftermath of a crisis.
Key Components:
Safety and Comfort: Ensuring that participants feel safe and secure in their environment.
Active Listening: Engaging in empathetic listening to validate participants' feelings and experiences.
Assessment of Needs: Identifying immediate needs and concerns, including emotional and practical aspects.
Information and Resources: Providing clear information about available resources, such as mental health services and coping strategies.
Encouragement of Social Support: Guiding participants to connect with friends, family, or support groups.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants: Undergraduate students identified as at risk for suicide. Interventions: Participants will receive both PFA and DBT at different times. PFA: Focuses on immediate emotional support and connecting students to resources.
DBT: A structured program that teaches coping skills, emotional regulation, and interpersonal effectiveness. Receives: Behavioral: Psychological First Aid versus Dialectal behavioral Intervention |
| Control | Active comparator | Group A: Begins with PFA followed by DBT. Group B: Begins with DBT followed by PFA. Receives: Behavioral: Psychological First Aid versus Dialectal behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidal Ideation Attributes Scale
It is a brief and reliable tool for assessing the severity of suicidal ideation over the past month, was developed by Van Spijker et al, (2014). It comprises five items that evaluate the frequency of suicidal thoughts, the level of control over these thoughts, proximity to a suicide attempt, the distress caused by the thoughts, and their impact on daily functioning.
Measured: 3 months
The Attitudes Toward Seeking Professional Psychological Help-Short Form
It is a 10-item scale to evaluate attitudes toward seeking psychological help. Responses are rated on a 4-point Likert scale ranging from 0 to 3, with higher scores indicating more favourable attitudes and lower stigma associated with mental illness
Measured: 3 months
Perception of Academic Stress Scale
It was developed by Bedewy, D., \& Gabriel, A. (2015), to measure sources of academic stress among university students. PAS IS an 18-item, 5-point Likert-type questionnaire designed, with a higher score indicating higher academic stress.
Measured: 3 months
The Brief Resilience Scale
It is a six-item self-report measure designed to assess resilience by Smith et al. (2008), specifically focusing on an individual's ability to bounce back or recover from stress. Unlike other resilience scales emphasizing resources or traits promoting resilience, the BRS directly evaluates recovery and adaptability following stressful events.
Measured: 3 months
The Self-Compassion Scale
It was developed by Dr. Kristin Neff, is a widely recognized tool designed to measure self-compassion, which encompasses being kind and understanding toward oneself in times of difficulty.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Dec 2024
- Primary completion15 Mar 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Khedr, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825351
- Sponsor's protocol ID
- 2025
- Status last verified
- Feb 2025
- First submitted
- 9 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Psychological First Aid Versus Dialectal Behavioral Intervention in Undergraduate Students With Suicide Risk: A Comparative Crossover Randomized ControlledTrial
- ClinicalTrials.gov ID
- NCT06825351
- Acronym / sponsor ID
- 2025
- Conditions
- Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 13 Feb 2025 (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.
his feasibility study aims to compare the effectiveness of Psychological First Aid (PFA) and Dialectical Behavior Therapy (DBT) interventions in reducing suicide risk among undergraduate students. The study employs a crossover randomized controlled trial design, allowing participants to experience both interventions at different times.
Detailed description
Suicide risk among undergraduate students is a pressing mental health concern, exacerbated by academic pressures and social isolation. Psychological First Aid (PFA) is a supportive intervention designed to reduce distress and foster coping in the immediate aftermath of a crisis. Conversely, Dialectical Behavior Therapy (DBT) is a structured, evidence-based therapy that focuses on emotional regulation, interpersonal effectiveness, and distress tolerance. This study explores the feasibility and effectiveness of these two interventions in a university setting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Psychological First Aid versus Dialectal behavioral InterventionParticipants: Undergraduate students identified as at risk for suicide. Interventions: Participants will receive both PFA and DBT at different times. PFA: Focuses on immediate emotional support and connecting students to resources. DBT: A structured program that teaches coping skills, emotional regulation, and interpersonal effectiveness. |
| Control | Active comparator | Behavioral: Psychological First Aid versus Dialectal behavioral InterventionGroup A: Begins with PFA followed by DBT. Group B: Begins with DBT followed by PFA. |
Who may qualify
- Ages
- 18 to 27 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants in this feasibility study must be undergraduate students aged 18-25 years who are identified as at risk for suicide based on a validated screening tool. They must be currently enrolled in a degree program, able to provide informed consent, and proficient in English.
Key exclusion criteria (1 listed)
- Individuals with severe mental illnesses (e.g., schizophrenia, bipolar disorder), those in acute crisis requiring immediate intervention, current substance abuse issues, significant cognitive impairments, prior experience with DBT or similar therapies within the last year, and physical health conditions that could complicate participation.
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 |
|---|---|---|
| Psychological First Aid versus Dialectal behavioral InterventionPFA is an immediate, supportive intervention aimed at helping individuals in distress. It focuses on providing emotional support and practical assistance in the aftermath of a crisis. Key Components: Safety and Comfort: Ensuring that participants feel safe and secure in their environment. Active Listening: Engaging in empathetic listening to validate participants' feelings and experiences. Assessment of Needs: Identifying immediate needs and concerns, including emotional and practical aspects. Information and Resources: Providing clear information about available resources, such as mental health services and coping strategies. Encouragement of Social Support: Guiding participants to connect with friends, family, or support groups. | Behavioural | Control, Intervention |
Primary outcome
Suicidal Ideation Attributes Scale
Time frame: 3 months
It is a brief and reliable tool for assessing the severity of suicidal ideation over the past month, was developed by Van Spijker et al, (2014). It comprises five items that evaluate the frequency of suicidal thoughts, the level of control over these thoughts, proximity to a suicide attempt, the distress caused by the thoughts, and their impact on daily functioning.
The Attitudes Toward Seeking Professional Psychological Help-Short Form
Time frame: 3 months
It is a 10-item scale to evaluate attitudes toward seeking psychological help. Responses are rated on a 4-point Likert scale ranging from 0 to 3, with higher scores indicating more favourable attitudes and lower stigma associated with mental illness
Perception of Academic Stress Scale
Time frame: 3 months
It was developed by Bedewy, D., \& Gabriel, A. (2015), to measure sources of academic stress among university students. PAS IS an 18-item, 5-point Likert-type questionnaire designed, with a higher score indicating higher academic stress.
The Brief Resilience Scale
Time frame: 3 months
It is a six-item self-report measure designed to assess resilience by Smith et al. (2008), specifically focusing on an individual's ability to bounce back or recover from stress. Unlike other resilience scales emphasizing resources or traits promoting resilience, the BRS directly evaluates recovery and adaptability following stressful events.
The Self-Compassion Scale
Time frame: 3 months
It was developed by Dr. Kristin Neff, is a widely recognized tool designed to measure self-compassion, which encompasses being kind and understanding toward oneself in times of difficulty.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological First Aid versus Dialectal behavioral Intervention in people with Suicidal Ideation, run by Alexandria University 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 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: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Suicidal Ideation Attributes Scale (time frame: 3 months). The study lists 5 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 13 Feb 2025.