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

NCT04428450 | Completed

• 1 other identifier: Berger_2011_deprexis
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Brief Symptom Inventory (53-item BSI)

  10 weeks

• Inventory of Interpersonal Problems (IIP)

  10 weeks

• WHOQOL-BREF

  10 weeks

Other Outcomes (1)

• CSQ-8 (Client Satisfaction Questionnaire)

  10 weeks

Study Arms (3)

Deprexis (unguided)

EXPERIMENTAL

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

Device: Deprexis

Deprexis (guided, with therapist)

EXPERIMENTAL

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

Device: Deprexis

Wait-list

NO INTERVENTION

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

Interventions

Deprexis DEVICE

CBT-based, integrative online self-help program

Deprexis (guided, with therapist); Deprexis (unguided)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Gaia AG: lead
• University of Bern: collaborator
• Linkoeping University: collaborator
• Karolinska Institutet: collaborator

Related Publications (1)

• 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.

  PMID: 22060248 RESULT

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Thomas Berger, Ph.D.

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: September 1, 2009
• Primary Completion: December 31, 2010
• Study Completion: December 31, 2010
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share