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

Internet-Based Treatment of Depression: A Randomized Controlled Trial Comparing Guided With Unguided Self-Help

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Device: Deprexis

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deprexis (unguided); web-based self-help program without any support from a therapist during the 10-week treatment period	Device: Deprexis; CBT-based, integrative online self-help program
Experimental: Deprexis (guided, with therapist); web-based self-help program plus scheduled e-mail contact with a therapist during the 10-week treatment period	Device: Deprexis; CBT-based, integrative online self-help program
No Intervention: Wait-list; Wait-list group (subjects receive access to Deprexis after 10 weeks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Symptom Inventory (53-item BSI)	Psychopathology severity self-report measure; minimum value = 0, maximum value = 4 (higher scores indicate more severe psychopathology).	10 weeks
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)	10 weeks
WHOQOL-BREF	Self-report quality of life measure; scores can range from 0 to 100, with higher scores indicating better quality of life.	10 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CSQ-8 (Client Satisfaction Questionnaire)	Self-report measure of global client satisfaction; scores can range from 1 to 4, with higher scores indicating greater satisfaction.	10 weeks

Collaborators and Investigators

• Sponsor: Gaia AG
• Collaborators: Karolinska Institutet; Linkoeping University; University of Bern
• Investigators: Principal Investigator: Thomas Berger, Ph.D., University of Bern

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2009
• Primary Completion (Actual): December 31, 2010
• Study Completion (Actual): December 31, 2010

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: Berger_2011_deprexis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Contact the PI for requests to use data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No