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CompletedNCT04363086Updated Apr 27, 2020

Adherence to the iFightDepression Online Self-help Tool for Mild and Moderate Depression

An interventional study of iFightDepression online self-help tool and Treatment as Usual in Depression, sponsored by Semmelweis University. Completed at 1 site in Hungary. Open to participants aged 15 Years to 82 Years. Per ClinicalTrials.gov, last updated 2020-04-27.

Sponsored by Semmelweis University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Jun 2017, registered Apr 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
73
Allocation
Non-randomized
Ages
15 Years to 82 Years
Sex
All
01

Study 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.

Read the detailed description

Depressive disorders are recognized as one of the most widespread lifetime disorders and unipolar depression is identified as a leading cause of disease burden . These findings legitimate the importance of reducing depressive symptoms by implementing cost-effective interventions. Despite the fact that cognitive behaviour therapy (CBT) is proved to be an efficient treatment for depression, mental health care resources are scarce and cannot fulfil the huge amount of need for face-to-face psychotherapeutic treatments. The aim of increasingly deploying computerized cognitive behavioural therapy (cCBT) is to improve access to psychological treatments, reduce waiting lists, speed up clinical recovery and to bridge the paucity of specialists in small towns. Moreover, guided web-based self-help interventions are proved to be cost-effective and time-saving for mental health care systems as well. Numerous studies have proved the cCBT to be effective in case of depression, however drop-out rates of online self-help interventions are usually high - between 5 and 38.7%. Systematic reviews showed that in web-based self-help treatments extra support obtains higher adherence than no guidance. Treatment-adherence, defined as the amount of a therapeutic intervention that an individual engages with or completes, has clear clinical implications: poor adherence limits the exposure to the full program and increases the required 'dosage' of treatment.

In the comparison of drop-out rates of different psychological treatments, no difference has been found between face-to-face and web-based interventions. Previous research has found that the drop-out risk from cCBT is significantly correlated with gender, educational level and age. Increased drop-out risk included male gender, younger age and lower educational level. This finding has been proved in another research as well, where females have been found to provide more effort to cope with depression compared to males.

With regard to adherence, a low educational level might negatively influence the adherence to cCBT as understanding the content of intervention can be troublesome. Results from previous studies suggested that younger individuals had higher adherence to web-based treatment, whilst some other studies showed that younger age was related to low treatment adherence. Several findings also suggested that additional forms of guidance or support via phone or email increase the level of adherence. In order to offer web-based treatment to patients with the most benefits, it would be useful to identify the predictors of treatment adherence and causes of the relatively high dropout rate.

Insomnia is one of the main symptoms of depression. Studies show insomnia to be one of the risk factors such for development of depression as for reducing response to depression treatment and increasing relapse of depression. Therefore, to quest a correlation between adherence in an online self-help program for depression and sleep disturbances would be subservient.

Our goal in this study was to identify predictors of adherence to a computerized CBT program and to investigate whether sociodemographic variables, hopelessness and sleep disturbances are connected to adherence. Another objective was to compare adherence in web-based self-help intervention with and without weekly follow-up phone-calls as extra support. Our hypothesis was that phone-support would increase adherence level of cCBT.

02

Conditions studied

  • Depression

Keywords

  • depression
  • adherence
  • online self-help
  • cognitive behavior therapy
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 73 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Semmelweis University is the lead sponsor of 136 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 82 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • mild symptoms of depression

Exclusion criteria

Exclusion Criteria:

  • acute psychotic episodes
  • acute suicidal behavior
  • acute substance abuse
  • bipolar disorder
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
73 participants (actual)

Study arms

  • Experimental
    TAU

    Behavioral: Treatment as Usual

  • Experimental
    iFD

    Behavioral: iFightDepression online self-help tool

  • Experimental
    iFD + weekly phone calls

    Behavioral: iFightDepression online self-help tool · Behavioral: phone call

Interventions

  • BehavioraliFightDepression online self-help tool

    Computerized cognitive behavior therapy

  • BehavioralTreatment as Usual

    TAU

  • Behavioralphone call

    phone call

06

What researchers measure

Primary outcomes

  1. Sociodemographic data

    gender, age, education and place of living

    Time frame: 6 weeks

  2. Depression

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

    Time frame: 6 weeks

  3. Hopelessness

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

    Time frame: 6 weeks

07

Study locations

1 site
  • Semmelweis University
    Budapest, 1089, Hungary
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04363086
Lead sponsor
Semmelweis University
Responsible party
Anna Varga (Clinical Psychologist, Psychotherapist, PhD student, Semmelweis University) — Principal investigator
First posted
Apr 27, 2020
Start date
Jun 12, 2017
Primary completion
Sep 12, 2017
Completion
Jun 12, 2018
Last update
Apr 27, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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