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
About this trial
This is an interventional treatment trial for Depression
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
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
NCT ID
NCT04428450
First Posted
June 9, 2020
Last Updated
June 12, 2020
Sponsor
Gaia AG
Collaborators
University of Bern, Linkoeping University, Karolinska Institutet
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
Learn more about this trial
Internet-Based Treatment of Depression: Comparing Guided With Unguided Self-Help
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