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NCT Number: NCT06192056

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

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.

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Key information

Conditions

Repetitive Negative Thinking Digestive System Diseases Feeding and Eating Disorders Gastrointestinal Diseases Mental Disorders Rumination Syndrome

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Halic University

Istanbul, Eyupsultan, Turkey (Türkiye)

About this study

After obtaining informed consent, all participants will receive a set of questionnaires for baseline measurement. Participants will be randomized into two groups using block randomization: one as the intervention group and the other as the control group (waitlist condition). This method helps ensure an equal distribution of participants with similar characteristics in both groups, minimizing potential biases and increasing the validity of the study.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • having internet connection and a working smart phone or computer

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Change from Baseline in Perseverative Thinking Questionnaire (PTQ) Scores

    Time frame: Baseline and Week 2

    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)

Secondary outcomes

  1. Improvement in Cognitive Fusion Questionnaire (CFQ) Scores

    Time frame: Baseline and Week 2

    Improvement is defined as a significant reduce in participants' CFQ scores. Turkish version of CFQ is a 7-item questionnaire assessed on 7-point Likert-type scale (1: "Never true"; 7: "Always true"). The validity and reliability study for Turkish version of the CFQ was conducted.

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

    Time frame: Baseline and Week 2

    The AAQ-II is a validated self-report instrument designed to measure psychological inflexibility. Higher scores on the AAQ-II indicate greater psychological inflexibility. The 7-item questionnaire has been found to be reliable and valid in Turkish.

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

    Time frame: Baseline and Week 2

    The DASS-21 consists of three subscales, each with 7 items rated on a scale of 0 (never) to 3 (always). The scale assesses depression, anxiety, and stress levels in the past week. The Turkish version of the scale has been found to be reliable and valid. Change (Post-intervention score- Baseline score)

  4. Increase in Committed Actions

    Time frame: Baseline and Week 2

    The change in participants' committed actions in life is measured by the Valuing Questionnaire (VQ). The questionnaire comprises 10 items rated on a 7-point Likert scale (0=Not at all true; 6=Completely true). A higher score on the scale indicates that individuals are behaving in a manner consistent with their values. Change (Post-intervention score- Baseline score)

  5. System Usability Assessment

    Time frame: Week 2

    The Turkish version of the System Usability Scale (SUS) will be administered at the conclusion of the 10-day web-based self-help program to assess the understandability and applicability of the program for participants. The SUS is a 10-item standardized questionnaire that offers a subjective assessment of usability. Participants rate the items on a scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree).

Sponsors and collaborators

Lead sponsor

Halic University

Other

Collaborators

  • CanSagligi Foundation

Registry information

Official study title

Feasibility and Preliminary Efficacy of Web-Based Self-Help Program on Repetitive Negative Thinking for College Students: A Randomized Pilot Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 5, 2024
Registry last updated
Jul 24, 2026

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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