Clinical trial NCT03754829: Effectiveness of a Web and Mobile Guided Psychological Intervention for Depressive Symptoms in Turkey
Official title: A Randomized Controlled Trial of a Web and Mobile Guided Psychological Intervention for Depressive Symptoms in Turkey.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Symptoms
Keywords: Randomized Controlled trial
Mobile Application
Problem-Solving Therapy
Online Guided Intervention
Lead sponsor: The Scientific and Technological Research Council of Turkey
Sponsor class: OTHER
Collaborators: name: Middle East Technical University
name: VU University of Amsterdam
First posted: 2018-11-27
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A three-armed randomized controlled trial with 2 experimental groups and 1 control group.
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Change on Beck Depression Inventory-II
timeFrame: Screening; baseline, 6-8 weeks after baseline and 4 months after baseline
Secondary outcomes:
measure: Change on State-Trait Anxiety Inventory (STAI)
timeFrame: baseline, 6-8 weeks after baseline and 4 months after baseline
measure: Change on Penn State Worry Questionnaire (PSWQ)
timeFrame: baseline, 6-8 weeks after baseline and 4 months after baseline
measure: Change on Perceived Stress Scale (PSS)
timeFrame: baseline, 6-8 weeks after baseline and 4 months after baseline
measure: Change on General Self-Efficacy Scale (GSE)
timeFrame: baseline, 6-8 weeks after baseline and 4 months after baseline
measure: Change on EuroQol-5D-5L (EQ-5D-5L)
timeFrame: baseline, 6-8 weeks after baseline and 4 months after baseline
measure: Satisfaction with the intervention questionnaire
timeFrame: 6-8 weeks after baseline only in the two experimental groups
Other outcomes:
measure: MINI-International Neuropsychiatric Interview
timeFrame: Screening
Locations:
city: Çankaya
country: Turkey
facility: Middle East Technical University
state: Ankara
Study officials:
References:
citation: Unlu Ince B, Gokcay D, Riper H, Cuijpers P. Effectiveness of a Web- and Mobile-Guided Psychological Intervention for Depressive Symptoms in Turkey: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Apr 5;8(4):e13239. doi: 10.2196/13239.