Evaluation of the Effectiveness of a Web-based Treatment Program for Depression for the Reduction of Depressive Symptoms

NCT01401296 | Completed

• 1 other identifier: Deprexis
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

200 persons with depression are recruited via internet depression forums devoted to depression and are randomly assigned either to the online program deprexis or to a wait-list control condition. All participants receive free-of-charge online access to deprexis either immediately or with an eight week delay. Prior to intervention and eight weeks later, both groups are assessed via an anonymous online survey which was implemented using the software package OPST®. The survey consists of different questionnaires. The Beck Depression Inventory (BDI) represents the primary outcome. It is assumed that the severity of depressive symptoms will improve to a significantly greater extent in the deprexis than in the wait-list control condition in the course of eight weeks.

Conditions

Depression

Keywords

Depression; Online-Therapy; Deprexis; Self-help

Outcome Measures

Primary Outcomes (1)

• Severity of depressive symptoms

  Severity of depressive symptoms as assessed with the Beck Depression Inventory (BDI)

  7 Days

Secondary Outcomes (1)

• quality of life as assessed by the WHO Quality of Life scale (WHO-QOL BREF)

  7 days

Study Arms (2)

Wait-list group

ACTIVE COMPARATOR

Subjects receive access to deprexis after eight weeks

Behavioral: Wait-list

Deprexis

EXPERIMENTAL

Web-based intervention deprexis consists of ten online modules (plus one introductory and one summary module) representing different psychotherapeutic strategies with a strong focus on evidence-based cognitive-behavioral techniques (e.g. interpersonal skills). Each module lasts approximately 10-60 minutes (e.g. depending on the user´s reading speed). Modules are sequential and organized as simulated dialogues. Each module refers and builds upon previous one. The program is delivered at no cost to participants.

Behavioral: Deprexis

Interventions

Deprexis BEHAVIORAL

Behavioral: Deprexis (10 sessions) delivered online versus wait-list control group

Also known as: web-based treatment program for depression

Deprexis

Wait-list BEHAVIORAL

Behavioral: the wait-list group receives Deprexis after 8 weeks

Also known as: web-based treatment for depression after 8 weeks

Wait-list group

Eligibility Criteria

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

You may qualify if:

• registration in a moderated online forum exclusively for affective disorders
• (externally) confirmed diagnosis of a unipolar depression
• informed consent (provided online in line with regulations by the Hamburg Department of Data Security)

You may not qualify if:

• unable to provide informed consent
• diagnosis of bipolar or schizophrenia spectrum disorders
• substantial neurological impairment (e.g. dementia)
• acute suicidal tendencies as assessed with the Suicide Behaviors Questionnaire-Revised (SBQ-R). Subjects excluded for this reason are provided various emergency contacts and phone numbers.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Links

• link to metacognitive training site, where training material can be downloaded cost-free

MeSH Terms

Conditions

Depression

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Steffen Mortz, PhD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 25, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 12, 2014

Record last verified: 2014-12

Locations

DE (1)