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

NCT ID: NCT06192056

Last Updated: 2024-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2023-12-22

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Repetitive Negative Thinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention group vs waitlist group
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

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

Group Type ACTIVE_COMPARATOR

RNT Focused Web- Based Self-Help Program

Intervention Type 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.

Waitlist group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CanSagligi Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fatih K Yavuz

Role: PRINCIPAL_INVESTIGATOR

İstanbul Medipol University

Locations

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CanSagligi Foundation

Istanbul, Uskudar, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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CSV202302

Identifier Type: -

Identifier Source: org_study_id

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