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NCT Number: NCT06825351

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Suicidal Ideation Behavior Behavioral Symptoms Self-Injurious Behavior Suicide

Age range

18 year–27 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Valley Committee

Qina, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psychological First Aid versus Dialectal behavioral Intervention

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.

Primary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 13, 2025
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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