Clinical trial NCT06192056: Feasibility and Preliminary Efficacy of a Web-Based Self-Help Program for College Students
Official title: Feasibility and Preliminary Efficacy of Web-Based Self-Help Program on Repetitive Negative Thinking for College Students: A Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Repetitive Negative Thinking
Keywords: Acceptance and Commitment Therapy
Rumination
Lead sponsor: CanSagligi Foundation
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group vs waitlist group
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Perseverative Thinking Questionnaire (PTQ) Scores
timeFrame: Baseline and Week 2
Secondary outcomes:
measure: Improvement in Cognitive Fusion Questionnaire (CFQ) Scores
timeFrame: Baseline and Week 2
measure: Enhancement in Psychological Flexibility measured by Acceptance and Action Questionnaire (AAQ-II)
timeFrame: Baseline and Week 2
measure: Change from Baseline in Depression Anxiety Stress Scale-21 (DASS-21) Scores
timeFrame: Baseline and Week 2
measure: Increase in Committed Actions
timeFrame: Baseline and Week 2
measure: System Usability Assessment
timeFrame: Week 2
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: CanSagligi Foundation
state: Uskudar
Study officials:
affiliation: İstanbul Medipol University
name: Fatih K Yavuz
role: PRINCIPAL_INVESTIGATOR
References: