Effectiveness of a Web and Mobile Guided Psychological Intervention for Depressive Symptoms in Turkey

Depressive Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03754829
• Other study ID #: No: 53325897-115.02-E.263941
• Status: Recruiting
• Phase: N/A
• Start date: March 19, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: November 2018
• Source: Tubitak
• Contact: Burçin Ünlü Ince, Ph.D.
• Phone: +905307341776
• Email: unlu_burcin[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 444
• Est. completion date: May 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

Intervention

Behavioral:
• Her Sey Kontrol Altinda (HSKA)
HSKA consists of 5 sessions over 5 weeks and is based on Problem-Solving therapy. Participants receive feedback on their homework assignments in brief weekly online messages from a clinical psychologist.

Locations

Country	Name	City	State
Turkey	Middle East Technical University	Çankaya	Ankara

Sponsors (3)

Lead Sponsor	Collaborator
Burçin Ünlü Ince	Middle East Technical University, VU University of Amsterdam

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MINI-International Neuropsychiatric Interview	Suicidal ideations	Screening
Primary	Change on Beck Depression Inventory-II	Depressive symptoms	Screening; baseline, 6-8 weeks after baseline and 4 months after baseline
Secondary	Change on State-Trait Anxiety Inventory (STAI)	Anxiety symptoms	baseline, 6-8 weeks after baseline and 4 months after baseline
Secondary	Change on Penn State Worry Questionnaire (PSWQ)	The PSWQ will be used to measure pathological worry. It has 16 items in total. Each item can be scored on a five-point scale from 1 (not at all typical of me) to 5 (very typical of me), with a total score varying from 16 to 80. Higher scores indicating greater worry.	baseline, 6-8 weeks after baseline and 4 months after baseline
Secondary	Change on Perceived Stress Scale (PSS)	The PSS will be used to measure the perception of stress. It consists of 10 items for which the total score range is 0-40. Each item is rated on a five-point scale, from 0 (never) to 4 (very often). Higher scores indicating greater stress.	baseline, 6-8 weeks after baseline and 4 months after baseline
Secondary	Change on General Self-Efficacy Scale (GSE)	The GSE is a measure to assess self-efficacy beliefs. It contains 10 items, which are rated on a four-point scale from 1 (not at all true) to 5 (exactly true). The total score varies from 10 to 50. Higher scores indicating greater self-efficacy beliefs.	baseline, 6-8 weeks after baseline and 4 months after baseline
Secondary	Change on EuroQol-5D-5L (EQ-5D-5L)	EQ-5D-5L will be used to measure quality of life. It consists of 5 items each measuring different dimensions of health status (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The items are rated on a five-point scale from level 1 to level 5 (no problems; slight, moderate; severe and extreme problems). All the answers to each item are combined resulting in 3125 possible health states, ranging from 11111 (full health) to 55555 (worst health). Furthermore, there is a visual analogue scale (EQ-VAS) measuring a global rating of self-perceived health. This is scored by 0 (the worst health you can imagine) to 100 (the best health you can imagine).	baseline, 6-8 weeks after baseline and 4 months after baseline
Secondary	Satisfaction with the intervention questionnaire	Participants will be asked about each module to define their satisfaction with the module concerned ('Was this lesson useful to you?'). The answers can be rated on a 5-point Likert scale from 1 (not at all) to 5 (very useful).	6-8 weeks after baseline only in the two experimental groups