NCT04363086

Brief Summary

Background Computerized cognitive behavioural therapy (cCBT) is proven to be an effective self-help tool for preventing depression and suicide. Patient adherence is one of the components that the effectiveness of cCBT self-help tools are dependent on and that needs to be researched for understanding and maximizing the effectiveness of computer-based interventions for depression and suicide. Aims The aims of this study were to compare the adherence of iFightDepression (iFD) online tool user patients with and without an extra weekly phone call consultation and to test predictors of adherence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
Last Updated

April 27, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

April 20, 2020

Last Update Submit

April 24, 2020

Conditions

Depression

Keywords

depressionadherenceonline self-helpcognitive behavior therapy

Outcome Measures

Primary Outcomes (3)

  • Sociodemographic data

    gender, age, education and place of living

    6 weeks

  • Depression

    Measured by Beck Depression Inventory; a) no depression; b) mild depression; c) moderate depression; d) severe depression

    6 weeks

  • Hopelessness

    Measured by Shortened Beck Hopelessness Scale; possible responses: no (0), yes (1)

    6 weeks

Study Arms (3)

TAU

EXPERIMENTAL
Behavioral: Treatment as Usual

iFD

EXPERIMENTAL
Behavioral: iFightDepression online self-help tool

iFD + weekly phone calls

EXPERIMENTAL
Behavioral: iFightDepression online self-help toolBehavioral: phone call

Interventions

iFightDepression online self-help toolBEHAVIORAL

Computerized cognitive behavior therapy

iFDiFD + weekly phone calls
Treatment as UsualBEHAVIORAL

TAU

TAU
phone callBEHAVIORAL

phone call

iFD + weekly phone calls

Eligibility Criteria

Age15 Years - 82 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • mild symptoms of depression

You may not qualify if:

  • acute psychotic episodes
  • acute suicidal behavior
  • acute substance abuse
  • bipolar disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Semmelweis University

Budapest, 1089, Hungary

Location

MeSH Terms

Conditions

Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychologist, Psychotherapist, PhD student

Study Record Dates

First Submitted

April 20, 2020

First Posted

April 27, 2020

Study Start

June 12, 2017

Primary Completion

September 12, 2017

Study Completion

June 12, 2018

Last Updated

April 27, 2020

Record last verified: 2020-04

Locations

HU(1)