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

Primary Purpose

Depressive Symptoms

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Her Sey Kontrol Altinda (HSKA)
Sponsored by
Burçin Ünlü İnce
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms focused on measuring Randomized Controlled trial, Mobile Application, Problem-Solving Therapy, Online Guided Intervention

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Middle East Technical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

HSKA - Web Group

HSKA - Mobile Group

Control Group

Arm Description

The first experimental group will receive direct access to the web version of HSKA.

The second experimental group will receive direct access to the mobile app of HSKA 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.

Outcomes

Primary Outcome Measures

Change on Beck Depression Inventory-II
Depressive symptoms

Secondary Outcome Measures

Change on State-Trait Anxiety Inventory (STAI)
Anxiety symptoms
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.
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.
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.
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).
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).

Full Information

First Posted
November 20, 2018
Last Updated
November 26, 2018
Sponsor
Burçin Ünlü İnce
Collaborators
Middle East Technical University, VU University of Amsterdam
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1. Study Identification

Unique Protocol Identification Number
NCT03754829
Brief Title
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 19, 2018 (Actual)
Primary Completion Date
April 1, 2019 (Anticipated)
Study Completion Date
May 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Burçin Ünlü İnce
Collaborators
Middle East Technical University, VU University of Amsterdam

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms
Keywords
Randomized Controlled trial, Mobile Application, Problem-Solving Therapy, Online Guided Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A three-armed randomized controlled trial with 2 experimental groups and 1 control group.
Masking
Investigator
Allocation
Randomized
Enrollment
444 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HSKA - Web Group
Arm Type
Experimental
Arm Description
The first experimental group will receive direct access to the web version of HSKA.
Arm Title
HSKA - Mobile Group
Arm Type
Experimental
Arm Description
The second experimental group will receive direct access to the mobile app of HSKA as well as automated supportive text messages based on PST.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Her Sey Kontrol Altinda (HSKA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change on Beck Depression Inventory-II
Description
Depressive symptoms
Time Frame
Screening; baseline, 6-8 weeks after baseline and 4 months after baseline
Secondary Outcome Measure Information:
Title
Change on State-Trait Anxiety Inventory (STAI)
Description
Anxiety symptoms
Time Frame
baseline, 6-8 weeks after baseline and 4 months after baseline
Title
Change on Penn State Worry Questionnaire (PSWQ)
Description
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.
Time Frame
baseline, 6-8 weeks after baseline and 4 months after baseline
Title
Change on Perceived Stress Scale (PSS)
Description
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.
Time Frame
baseline, 6-8 weeks after baseline and 4 months after baseline
Title
Change on General Self-Efficacy Scale (GSE)
Description
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.
Time Frame
baseline, 6-8 weeks after baseline and 4 months after baseline
Title
Change on EuroQol-5D-5L (EQ-5D-5L)
Description
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).
Time Frame
baseline, 6-8 weeks after baseline and 4 months after baseline
Title
Satisfaction with the intervention questionnaire
Description
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).
Time Frame
6-8 weeks after baseline only in the two experimental groups
Other Pre-specified Outcome Measures:
Title
MINI-International Neuropsychiatric Interview
Description
Suicidal ideations
Time Frame
Screening

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Burçin Ünlü Ince, Ph.D.
Phone
+905307341776
Email
unlu_burcin@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Didem Gökçay, Ph.D.
Phone
+90312210 3750
Email
dgokcay@metu.edu.tr
Facility Information:
Facility Name
Middle East Technical University
City
Çankaya
State/Province
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didem Gökçay, Ph.D.
Phone
+903122103750
Email
dgokcay@metu.edu.tr
First Name & Middle Initial & Last Name & Degree
Burçin Ünlü Ince, Ph.D.
Phone
+905307341776
Email
unlu_burcin@outlook.com
First Name & Middle Initial & Last Name & Degree
Didem Gökçay, Ph.D.
First Name & Middle Initial & Last Name & Degree
Burçin Ünlü Ince, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30950802
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.
Results Reference
derived

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

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