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Depressive SymptomsNCT03754829

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

A study testing Her Sey Kontrol Altinda (HSKA) in people with Depressive Symptoms, run by Burçin Ünlü İnce at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Depressive Symptoms
What is being tested?
Her Sey Kontrol Altinda (HSKA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
444 participants
Where
1 siteTurkey (Türkiye)
Study dates
19 Mar 2018to 1 May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Burçin Ünlü Ince, Ph.D. contact

+905307341776

unlu_burcin@outlook.com

Didem Gökçay, Ph.D. contact

+90312210 3750

dgokcay@metu.edu.tr

Turkey (Türkiye)1 site, 1 recruiting

  • Middle East Technical University

    Çankaya, Ankara, 06800

    Didem Gökçay, Ph.D., +903122103750, dgokcay@metu.edu.tr

    Burçin Ünlü Ince, Ph.D., +905307341776, unlu_burcin@outlook.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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).

Being tested
Her Sey Kontrol Altinda (HSKA)
Keywords
Randomized Controlled trial, Mobile Application, Problem-Solving Therapy, Online Guided Intervention
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Her Sey Kontrol Altinda (HSKA)Behavioural

    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.

Study groups in NCT03754829
Study groupRoleWhat they receive
HSKA - Web GroupExperimentalThe first experimental group will receive direct access to the web version of HSKA.
Receives: Behavioral: Her Sey Kontrol Altinda (HSKA)
HSKA - Mobile GroupExperimentalThe second experimental group will receive direct access to the mobile app of HSKA as well as automated supportive text messages based on PST.
Receives: Behavioral: Her Sey Kontrol Altinda (HSKA)
Control GroupNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Change on Beck Depression Inventory-II

    Depressive symptoms

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

Secondary outcomes (6)

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

    Anxiety symptoms

    Measured: baseline, 6-8 weeks after baseline and 4 months after baseline

  2. 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.

    Measured: baseline, 6-8 weeks after baseline and 4 months after baseline

  3. 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.

    Measured: baseline, 6-8 weeks after baseline and 4 months after baseline

  4. 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.

    Measured: baseline, 6-8 weeks after baseline and 4 months after baseline

  5. 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).

    Measured: baseline, 6-8 weeks after baseline and 4 months after baseline

  6. 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).

    Measured: 6-8 weeks after baseline only in the two experimental groups

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2018
  2. Study start19 Mar 2018
  3. Primary completion1 Apr 2019 (estimated)
  4. Study completion1 May 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A three-armed randomized controlled trial with 2 experimental groups and 1 control group.
Masking
Single blind
Who is masked
Investigator
Enrolment
444 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03754829
Sponsor's protocol ID
No: 53325897-115.02-E.263941
Status last verified
Nov 2018
First submitted
20 Nov 2018
Last updated
27 Nov 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 30950802

Questions about this trial

What is this clinical trial studying?

A study testing Her Sey Kontrol Altinda (HSKA) in people with Depressive Symptoms, run by Burçin Ünlü İnce at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Burçin Ünlü Ince, Ph.D. (+905307341776, unlu_burcin@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change on Beck Depression Inventory-II (time frame: Screening; baseline, 6-8 weeks after baseline and 4 months after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03754829, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018.

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