NCT03754829

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
444

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

November 27, 2018

Status Verified

November 1, 2018

Enrollment Period

1 year

First QC Date

November 20, 2018

Last Update Submit

November 26, 2018

Conditions

Depressive Symptoms

Keywords

Randomized Controlled trialMobile ApplicationProblem-Solving TherapyOnline Guided Intervention

Outcome Measures

Primary Outcomes (1)

  • Change on Beck Depression Inventory-II

    Depressive symptoms

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

Secondary Outcomes (6)

  • Change on State-Trait Anxiety Inventory (STAI)

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

  • Change on Penn State Worry Questionnaire (PSWQ)

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

  • Change on Perceived Stress Scale (PSS)

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

  • Change on General Self-Efficacy Scale (GSE)

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

  • Change on EuroQol-5D-5L (EQ-5D-5L)

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

  • +1 more secondary outcomes

Other Outcomes (1)

  • MINI-International Neuropsychiatric Interview

    Screening

Study Arms (3)

HSKA - Web Group

EXPERIMENTAL

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

Behavioral: Her Sey Kontrol Altinda (HSKA)

HSKA - Mobile Group

EXPERIMENTAL

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)

Control Group

NO INTERVENTION

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.

Interventions

Her Sey Kontrol Altinda (HSKA)BEHAVIORAL

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.

HSKA - Mobile GroupHSKA - Web Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Middle East Technical University

Çankaya, Ankara, 06800, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30950802DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Central Study Contacts

Burçin Ünlü Ince, Ph.D.

CONTACT

+905307341776unlu_burcin@outlook.com

Didem Gökçay, Ph.D.

CONTACT

+90312210 3750dgokcay@metu.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A three-armed randomized controlled trial with 2 experimental groups and 1 control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ph.D., Postdoctoral Researcher

Study Record Dates

First Submitted

November 20, 2018

First Posted

November 27, 2018

Study Start

March 19, 2018

Primary Completion

April 1, 2019

Study Completion

May 1, 2019

Last Updated

November 27, 2018

Record last verified: 2018-11

Locations

TU(1)