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

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
iFightDepression online self-help tool
Treatment as Usual
phone call
Sponsored by
Semmelweis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring depression, adherence, online self-help, cognitive behavior therapy

Eligibility Criteria

15 Years - 82 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • mild symptoms of depression

Exclusion Criteria:

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

Sites / Locations

  • Semmelweis University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

TAU

iFD

iFD + weekly phone calls

Arm Description

Outcomes

Primary Outcome Measures

Sociodemographic data
gender, age, education and place of living
Depression
Measured by Beck Depression Inventory; a) no depression; b) mild depression; c) moderate depression; d) severe depression
Hopelessness
Measured by Shortened Beck Hopelessness Scale; possible responses: no (0), yes (1)

Secondary Outcome Measures

Full Information

First Posted
April 20, 2020
Last Updated
April 24, 2020
Sponsor
Semmelweis University
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1. Study Identification

Unique Protocol Identification Number
NCT04363086
Brief Title
Adherence to the iFightDepression Online Self-help Tool for Mild and Moderate Depression
Official Title
Adherence to the iFightDepression Online Self-help Tool for Mild and Moderate Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 12, 2017 (Actual)
Primary Completion Date
September 12, 2017 (Actual)
Study Completion Date
June 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Semmelweis University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, adherence, online self-help, cognitive behavior therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAU
Arm Type
Experimental
Arm Title
iFD
Arm Type
Experimental
Arm Title
iFD + weekly phone calls
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
iFightDepression online self-help tool
Intervention Description
Computerized cognitive behavior therapy
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
TAU
Intervention Type
Behavioral
Intervention Name(s)
phone call
Intervention Description
phone call
Primary Outcome Measure Information:
Title
Sociodemographic data
Description
gender, age, education and place of living
Time Frame
6 weeks
Title
Depression
Description
Measured by Beck Depression Inventory; a) no depression; b) mild depression; c) moderate depression; d) severe depression
Time Frame
6 weeks
Title
Hopelessness
Description
Measured by Shortened Beck Hopelessness Scale; possible responses: no (0), yes (1)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: mild symptoms of depression Exclusion Criteria: acute psychotic episodes acute suicidal behavior acute substance abuse bipolar disorder
Facility Information:
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1089
Country
Hungary

12. IPD Sharing Statement

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

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