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Internet-Based Treatment of Depression: Comparing Guided With Unguided Self-Help

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Deprexis
Sponsored by
Gaia AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • access to the internet
  • informed consent to participate
  • BDI-II score > 13
  • if prescribed, constant dosage of medication (depression/anxiety) for 1 month prior and during study

Exclusion Criteria:

  • suicide item of BDI ≥ 2
  • other psychological treatment during this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Deprexis (unguided)

    Deprexis (guided, with therapist)

    Wait-list

    Arm Description

    web-based self-help program without any support from a therapist during the 10-week treatment period

    web-based self-help program plus scheduled e-mail contact with a therapist during the 10-week treatment period

    Wait-list group (subjects receive access to Deprexis after 10 weeks)

    Outcomes

    Primary Outcome Measures

    Beck Depression Inventory - II (BDI-II)
    Self-report questionnaire, depression symptom severity, scores can range from 0 to 63, with higher scores indicating more severe depression.

    Secondary Outcome Measures

    Brief Symptom Inventory (53-item BSI)
    Psychopathology severity self-report measure; minimum value = 0, maximum value = 4 (higher scores indicate more severe psychopathology).
    Inventory of Interpersonal Problems (IIP)
    Self-report measure of interpersonal problems; total score computed as the mean across all items; minimum value = 0, maximum value = 4 (higher scores indicate more severe psychopathology)
    WHOQOL-BREF
    Self-report quality of life measure; scores can range from 0 to 100, with higher scores indicating better quality of life.

    Full Information

    First Posted
    June 9, 2020
    Last Updated
    June 12, 2020
    Sponsor
    Gaia AG
    Collaborators
    University of Bern, Linkoeping University, Karolinska Institutet
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04428450
    Brief Title
    Internet-Based Treatment of Depression: Comparing Guided With Unguided Self-Help
    Official Title
    Internet-Based Treatment of Depression: A Randomized Controlled Trial Comparing Guided With Unguided Self-Help
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2009 (Actual)
    Primary Completion Date
    December 31, 2010 (Actual)
    Study Completion Date
    December 31, 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Gaia AG
    Collaborators
    University of Bern, Linkoeping University, Karolinska Institutet

    4. Oversight

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

    5. Study Description

    Brief Summary
    The study is a randomized controlled trial and to compare the benefits of a 10-week web-based unguided self-help treatment with the same intervention complemented with weekly therapist support via e-mail. A waiting-list control group will be included. The Beck Depression Inventory (BDI-II) will be used as the primary outcome measure. Secondary outcomes include general psychopathology, interpersonal problems, and quality of life.
    Detailed Description
    Depression is a major health problem associated with significant disability and economic costs. Although depression can be treated effectively with several psychological and pharmacological treatment options, many sufferers still seek or receive inadequate therapy or no therapy at all. Internet-based treatments may help to serve this demand, being accessible anytime and anywhere making it easier for underserved populations and people living in remote areas to receive treatment. The present study aims to assess the efficacy of an internet-based CBT intervention for depression (Deprexis), directly comparing the benefits of a low intensity therapist-guided with an unguided self-help version. A waiting-list control group will be included. Individuals meeting the diagnostic criteria of major depression or dysthymia will be randomly assigned to one of the three conditions. While unguided self-help will not include any contact with a therapist or the study team during the treatment, guided self-help will include a weekly scheduled e-mail feedback by a therapist and the possibility to ask questions via e-mail. While in an earlier study Deprexis was assessed as an add-on to TAU, this study will examine the efficacy of the program when delivered as a stand-alone intervention (i.e., only individuals who currently do not receive psychotherapy will be included). Moreover, this study will include a structured diagnostic interview at pretreatment. Only participants fulfilling the criteria of a depressive disorder (major depression or dysthymia) will be included in the trial. Participants will be recruited in Switzerland and Germany via articles in national and regional newspapers and a national television interview. All questionnaires will be administered via the internet. The 21-item BDI-II will be used as the main outcome measure. Secondary outcome measures will include the Brief Symptom Inventory (53-item BSI), the Inventory of Interpersonal Problems (64-item IIP), and the WHOQOL-BREF.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    76 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Deprexis (unguided)
    Arm Type
    Experimental
    Arm Description
    web-based self-help program without any support from a therapist during the 10-week treatment period
    Arm Title
    Deprexis (guided, with therapist)
    Arm Type
    Experimental
    Arm Description
    web-based self-help program plus scheduled e-mail contact with a therapist during the 10-week treatment period
    Arm Title
    Wait-list
    Arm Type
    No Intervention
    Arm Description
    Wait-list group (subjects receive access to Deprexis after 10 weeks)
    Intervention Type
    Device
    Intervention Name(s)
    Deprexis
    Intervention Description
    CBT-based, integrative online self-help program
    Primary Outcome Measure Information:
    Title
    Beck Depression Inventory - II (BDI-II)
    Description
    Self-report questionnaire, depression symptom severity, scores can range from 0 to 63, with higher scores indicating more severe depression.
    Time Frame
    10 weeks
    Secondary Outcome Measure Information:
    Title
    Brief Symptom Inventory (53-item BSI)
    Description
    Psychopathology severity self-report measure; minimum value = 0, maximum value = 4 (higher scores indicate more severe psychopathology).
    Time Frame
    10 weeks
    Title
    Inventory of Interpersonal Problems (IIP)
    Description
    Self-report measure of interpersonal problems; total score computed as the mean across all items; minimum value = 0, maximum value = 4 (higher scores indicate more severe psychopathology)
    Time Frame
    10 weeks
    Title
    WHOQOL-BREF
    Description
    Self-report quality of life measure; scores can range from 0 to 100, with higher scores indicating better quality of life.
    Time Frame
    10 weeks
    Other Pre-specified Outcome Measures:
    Title
    CSQ-8 (Client Satisfaction Questionnaire)
    Description
    Self-report measure of global client satisfaction; scores can range from 1 to 4, with higher scores indicating greater satisfaction.
    Time Frame
    10 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: access to the internet informed consent to participate BDI-II score > 13 if prescribed, constant dosage of medication (depression/anxiety) for 1 month prior and during study Exclusion Criteria: suicide item of BDI ≥ 2 other psychological treatment during this study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thomas Berger, Ph.D.
    Organizational Affiliation
    University of Bern
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Contact the PI for requests to use data.
    Citations:
    PubMed Identifier
    22060248
    Citation
    Berger T, Hammerli K, Gubser N, Andersson G, Caspar F. Internet-based treatment of depression: a randomized controlled trial comparing guided with unguided self-help. Cogn Behav Ther. 2011;40(4):251-66. doi: 10.1080/16506073.2011.616531.
    Results Reference
    result

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    Internet-Based Treatment of Depression: Comparing Guided With Unguided Self-Help

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