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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| TAU | Experimental | Not described Receives: Behavioral: Treatment as Usual |
| iFD | Experimental | Not described Receives: Behavioral: iFightDepression online self-help tool |
| iFD + weekly phone calls | Experimental | Not 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.
Sociodemographic data
gender, age, education and place of living
Measured: 6 weeks
Depression
Measured by Beck Depression Inventory; a) no depression; b) mild depression; c) moderate depression; d) severe depression
Measured: 6 weeks
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.
- First posted27 Apr 2020
- Study start12 Jun 2017
- Primary completion12 Sep 2017
- Study completion12 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Varga, Semmelweis University
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to the iFightDepression Online Self-help Tool for Mild and Moderate Depression
- ClinicalTrials.gov ID
- NCT04363086
- Acronym / sponsor ID
- SE TUKEB 5/2017
- Conditions
- Depression
- Keywords
- depression, adherence, online self-help, cognitive behavior therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 12 Sep 2017 (actual)
- Study completion
- 12 Jun 2018 (actual)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAU | Experimental | Behavioral: Treatment as Usual |
| iFD | Experimental | Behavioral: iFightDepression online self-help tool |
| iFD + weekly phone calls | Experimental | Behavioral: iFightDepression online self-help tool, Behavioral: phone call |
Who may qualify
- Ages
- 15 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- mild symptoms of depression
Key exclusion criteria (4 listed)
- acute psychotic episodes
- acute suicidal behavior
- acute substance abuse
- bipolar disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iFightDepression online self-help toolComputerized cognitive behavior therapy | Behavioural | iFD, iFD + weekly phone calls |
| Treatment as UsualTAU | Behavioural | TAU |
| phone callphone call | Behavioural | iFD + weekly phone calls |
Primary outcome
Sociodemographic data
Time frame: 6 weeks
gender, age, education and place of living
Depression
Time frame: 6 weeks
Measured by Beck Depression Inventory; a) no depression; b) mild depression; c) moderate depression; d) severe depression
Hopelessness
Time frame: 6 weeks
Measured by Shortened Beck Hopelessness Scale; possible responses: no (0), yes (1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.