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Clinical Trials/NCT03754829
NCT03754829
Unknown
N/A

A Randomized Controlled Trial of a Web and Mobile Guided Psychological Intervention for Depressive Symptoms in Turkey.

Burçin Ünlü İnce1 site in 1 country444 target enrollmentMarch 19, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depressive Symptoms
Sponsor
Burçin Ünlü İnce
Enrollment
444
Locations
1
Primary Endpoint
Change on Beck Depression Inventory-II
Last Updated
7 years ago

Overview

Brief Summary

The aim of this study is to test the clinical effects of a web and mobile application of guided Problem Solving Therapy for depressive symptoms among the general population in Turkey.

Detailed Description

In Turkey, there are serious deficiencies in mental health care. Among these, undertreatment of mentally ill patients, lack of psychologists and inadequate psychosocial and rehabilitation options for patients and their relatives are important prohibiting factors that reduce patients' outreach for getting help. While depression is highly prevalent (4.4%), only a small number of people seek professional help (18%) in Turkey. Innovative solutions are needed to overcome this treatment gap. Online Problem-Solving Therapy (PST) is a brief intervention proven to be effective in the treatment of depression, although little is known about its clinical effects in Turkey. The aim of this study is to test the clinical effects of a web and mobile application of PST for depressive symptoms among the general population in Turkey. Participants will be recruited through announcements in social media and the Middle East Technical University. A randomized controlled trial with a sample size of 444 participants randomized across three groups will be utilized. The first experimental group will receive direct access to the web version of the intervention; the second experimental group will receive direct access to the mobile app of the intervention as well as automated supportive text messages based on PST. The control group consists of a wait-list and for ethical reasons, participants in this group will gain access to the intervention (either web or mobile application) four months after the baseline. The intervention is based on an existing PST for the Turkish population, "Her Sey Kontrol Altinda" (HSKA).

Registry
clinicaltrials.gov
Start Date
March 19, 2018
End Date
May 1, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Burçin Ünlü İnce
Responsible Party
Sponsor Investigator
Principal Investigator

Burçin Ünlü İnce

Ph.D., Postdoctoral Researcher

The Scientific and Technological Research Council of Turkey

Eligibility Criteria

Inclusion Criteria

  • Turkish participants living in Turkey are eligible if the applicants are aged between 18-55 years and have mild to moderate depressive symptoms (Beck Depression Inventory-II score between 10 and 29).

Exclusion Criteria

  • Participants will be excluded if they have a BDI-II score above 29, or a medium-to- high suicidal risk (according to the MINI-International Neuropsychiatric Interview) and are advised to contact a psychiatrist or clinical psychologist.

Outcomes

Primary Outcomes

Change on Beck Depression Inventory-II

Time Frame: Screening; baseline, 6-8 weeks after baseline and 4 months after baseline

Depressive symptoms

Secondary Outcomes

  • Change on Penn State Worry Questionnaire (PSWQ)(baseline, 6-8 weeks after baseline and 4 months after baseline)
  • Satisfaction with the intervention questionnaire(6-8 weeks after baseline only in the two experimental groups)
  • Change on State-Trait Anxiety Inventory (STAI)(baseline, 6-8 weeks after baseline and 4 months after baseline)
  • Change on Perceived Stress Scale (PSS)(baseline, 6-8 weeks after baseline and 4 months after baseline)
  • Change on General Self-Efficacy Scale (GSE)(baseline, 6-8 weeks after baseline and 4 months after baseline)
  • Change on EuroQol-5D-5L (EQ-5D-5L)(baseline, 6-8 weeks after baseline and 4 months after baseline)

Study Sites (1)

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