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

August 12, 2024 updated by: CanSagligi Foundation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

50

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

  • Turkey
    • Uskudar
      • Istanbul, Uskudar, Turkey
        • CanSagligi Foundation

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

Yes

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention group
The RNT-focused web based self-help program will be given to the intervention group.
Behavioral: RNT Focused Web- Based Self-Help Program
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.
No Intervention: Waitlist group
Waitlist group will be given only pre and post test measures at the same time with the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline and Week 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 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.
Baseline and Week 2
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)
Baseline and Week 2
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)
Baseline and Week 2
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).
Week 2

Collaborators and Investigators

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

Sponsor

CanSagligi Foundation

Investigators

  • Principal Investigator: Fatih K Yavuz, İstanbul Medipol University

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, 2023

Primary Completion (Actual)

December 22, 2023

Study Completion (Actual)

December 22, 2023

Study Registration Dates

First Submitted

December 7, 2023

First Submitted That Met QC Criteria

January 4, 2024

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 12, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CSV202302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data would be available upon request.

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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