A Feasibility Study of Psychological First Aid Versus Dialectal Behavioral Intervention in Undergraduate Students With Suicide Risk: A Comparative Crossover Randomized ControlledTrial

NCT ID: NCT06825351

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-03-15

Brief Summary

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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

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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

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Suicidal Ideation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Psychological First Aid versus Dialectal behavioral Intervention

Intervention Type BEHAVIORAL

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.

Control

Group A: Begins with PFA followed by DBT. Group B: Begins with DBT followed by PFA.

Group Type ACTIVE_COMPARATOR

Psychological First Aid versus Dialectal behavioral Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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Psychological First Aid versus Dialectal behavioral Intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

27 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Khedr

Dr Mahmoud Khedr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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South Valley Committee

Qina, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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2025

Identifier Type: -

Identifier Source: org_study_id

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