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

November 26, 2018 updated by: Burçin Ünlü İnce

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

444

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ankara
      • Çankaya, Ankara, Turkey, 06800
        • Recruiting
        • Middle East Technical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Didem Gökçay, Ph.D.
        • Principal Investigator:
          • Burçin Ünlü Ince, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HSKA - Web Group
The first experimental group will receive direct access to the web version of HSKA.
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.
Experimental: HSKA - Mobile Group
The second experimental group will receive direct access to the mobile app of HSKA as well as automated supportive text messages based on PST.
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.
No Intervention: Control Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change on Beck Depression Inventory-II
Time Frame: Screening; baseline, 6-8 weeks after baseline and 4 months after baseline
Depressive symptoms
Screening; baseline, 6-8 weeks after baseline and 4 months after baseline

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
MINI-International Neuropsychiatric Interview
Time Frame: Screening
Suicidal ideations
Screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Burçin Ünlü İnce

Collaborators

VU University of Amsterdam
Middle East Technical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2018

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

November 20, 2018

First Submitted That Met QC Criteria

November 26, 2018

First Posted (Actual)

November 27, 2018

Study Record Updates

Last Update Posted (Actual)

November 27, 2018

Last Update Submitted That Met QC Criteria

November 26, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No: 53325897-115.02-E.263941

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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