Feasibility and Preliminary Efficacy of a Web-Based Self-Help Program for College Students

NCT06192056 | Completed

• 1 other identifier: CSV202302
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot study is to test the feasibility and preliminary efficacy of the repetitive negative thinking (RNT) focused web-based self-help program in college students. The main questions it aims to answer are:

• Does the program work without any help of a clinician?
• Does the program have any reducing effect on the participants' RNT, depression, anxiety, stress and cognitive fusion scores? - Does the program help participants to improve their psychological flexibility and committed actions? Participants will be administered a set of questionnaires before and after completing the 10-day long web-based self-help program, provided on a daily basis. Researchers will compare the intervention group with a waitlist control group to assess for any potential placebo effect.

Conditions

Repetitive Negative Thinking

Keywords

Acceptance and Commitment Therapy; Rumination

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Perseverative Thinking Questionnaire (PTQ) Scores

  The PTQ is a validated self-report instrument assessed content-independent trait-based RNT. It consists of 15 items that rated on the score of 0 (never) to 4 (almost always). The reliability and validity of the Turkish version of the scale is checked and it found suitable for Turkish population. Change (Post-intervention score- Baseline score)

  Baseline and Week 2

Secondary Outcomes (5)

• Improvement in Cognitive Fusion Questionnaire (CFQ) Scores

  Baseline and Week 2

• Enhancement in Psychological Flexibility measured by Acceptance and Action Questionnaire (AAQ-II)

  Baseline and Week 2

• Change from Baseline in Depression Anxiety Stress Scale-21 (DASS-21) Scores

  Baseline and Week 2

• Increase in Committed Actions

  Baseline and Week 2

• System Usability Assessment

  Week 2

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

The RNT-focused web based self-help program will be given to the intervention group.

Behavioral: RNT Focused Web- Based Self-Help Program

Waitlist group

NO INTERVENTION

Waitlist group will be given only pre and post test measures at the same time with the intervention group.

Interventions

RNT Focused Web- Based Self-Help Program BEHAVIORAL

This 10 day long intervention contains psychoeducational contents, experimental exercises, monitoring behavior and committed action strategies. Each step of the intervention aims to develop a specific psychological flexibility skill like cognitive defusion etc.

Intervention group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• having internet connection and a working smart phone or computer

You may not qualify if:

• having thoughts of self-harm or suicide,
• diagnosed with psychotic disorder,
• substance abuse
• currently receiving psychological help

Sponsors & Collaborators

• CanSagligi Foundation: lead

Study Sites (1)

CanSagligi Foundation

Istanbul, Uskudar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rumination Syndrome

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Mental Disorders

Study Officials

• Fatih K Yavuz

  İstanbul Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention group vs waitlist group

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: January 5, 2024
• Study Start: December 1, 2023
• Primary Completion: December 22, 2023
• Study Completion: December 22, 2023
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)