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

Repetitive Negative Thinking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06192056
• Other study ID #: CSV202302
• Status: Completed
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 22, 2023

Study information

• Verified date: January 2024
• Source: CanSagligi Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 22, 2023
• Est. primary completion date: December 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Repetitive Negative Thinking

Intervention

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.

Locations

Country	Name	City	State
Turkey	CanSagligi Foundation	Istanbul	Uskudar

Sponsors (1)

Lead Sponsor	Collaborator
CanSagligi Foundation

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improvement in Cognitive Fusion Questionnaire (CFQ) Scores	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
Secondary	Enhancement in Psychological Flexibility measured by Acceptance and Action Questionnaire (AAQ-II)	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
Secondary	Change from Baseline in Depression Anxiety Stress Scale-21 (DASS-21) Scores	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
Secondary	Increase in Committed Actions	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
Secondary	System Usability Assessment	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