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DepressionNCT04363086

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

A study testing iFightDepression online self-help tool, Treatment as Usual and phone call in people with Depression, run by Semmelweis University at 1 site in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 15 to 82 years
Conditions the study is for
Depression
What is being tested?
iFightDepression online self-help tool, Treatment as Usual and phone call
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteHungary
Study dates
12 Jun 2017to 12 Jun 2018
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 15 to 82 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • mild symptoms of depression

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Hungary1 site
  • Semmelweis University

    Budapest, 1089

Other trials in Hungary

About this study

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.

Conditions
Depression
Being tested
iFightDepression online self-help tool, Treatment as Usual, phone call
Keywords
depression, adherence, online self-help, cognitive behavior therapy
Medical subject headings
Depression

What participants receive

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

  • iFightDepression online self-help toolBehavioural

    Computerized cognitive behavior therapy

  • Treatment as UsualBehavioural

    TAU

  • phone callBehavioural

    phone call

Study groups in NCT04363086
Study groupRoleWhat they receive
TAUExperimentalNot described
Receives: Behavioral: Treatment as Usual
iFDExperimentalNot described
Receives: Behavioral: iFightDepression online self-help tool
iFD + weekly phone callsExperimentalNot described
Receives: Behavioral: iFightDepression online self-help tool; Behavioral: phone call

What is being measured

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

  1. Sociodemographic data

    gender, age, education and place of living

    Measured: 6 weeks

  2. Depression

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

    Measured: 6 weeks

  3. Hopelessness

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

    Measured: 6 weeks

Timeline

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

  1. First posted27 Apr 2020
  2. Study start12 Jun 2017
  3. Primary completion12 Sep 2017
  4. Study completion12 Jun 2018

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
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04363086
Sponsor's protocol ID
SE TUKEB 5/2017
Status last verified
Apr 2020
First submitted
20 Apr 2020
Last updated
27 Apr 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing iFightDepression online self-help tool, Treatment as Usual and phone call in people with Depression, run by Semmelweis University at 1 site in Hungary.

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 4 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: finished, as of the sponsor's last update on 27 Apr 2020. 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 Hungary. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sociodemographic data (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 Apr 2020.

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Clinical Trial NCT04363086 | AzTrials