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

February 9, 2025 updated by: Mahmoud Khedr, Alexandria University
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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Qinā, Egypt
        • South Valley Committee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

March 15, 2025

Study Completion (Estimated)

March 15, 2025

Study Registration Dates

First Submitted

February 9, 2025

First Submitted That Met QC Criteria

February 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 9, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

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

No

Studies a U.S. FDA-regulated device product

No

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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