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

NCT06825351 | Active Not Recruiting DMC

• 1 other identifier: 2025
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. The study employs a crossover randomized controlled trial design, allowing participants to experience both interventions at different times.

Conditions

Suicidal Ideation

Outcome Measures

Primary Outcomes (5)

• 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.

  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

  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.

  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.

  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.

  3 months

Study Arms (2)

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.

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.

Behavioral: Psychological First Aid versus Dialectal behavioral Intervention

Interventions

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.

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 27 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

South Valley Committee

Qina, Egypt

Location

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Mahmoud Khedr

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: February 13, 2025
• Study Start: December 1, 2024
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

EG (1)