- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06825351
A Feasibility Study of Psychological First Aid Versus Dialectal Behavioral Intervention in Undergraduate Students With Suicide Risk: A Comparative Crossover Randomized ControlledTrial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Qinā, Egypt
- South Valley Committee
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
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. |
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. |
|
Active Comparator: Control
Group A: Begins with PFA followed by DBT.
Group B: Begins with DBT followed by PFA.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 months
|
|
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
|
3 months
|
|
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.
|
3 months
|
|
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.
|
3 months
|
|
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.
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025 (Other Identifier: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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