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

NCT ID: NCT01401296

Last Updated: 2014-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Deprexis is a web-based intervention that can be obtained online (www.deprexis.com). Deprexis encompasses 10 content modules with a strong focus on evidence-based cognitive-behavioral techniques, either from its so-called first (behavior-oriented), second (cognitive-oriented) or third wave (e.g. mindfulness and acceptance): (1) psychoeducation, (2) behavioral activation, (3) cognitive modification, (4) mindfulness and acceptance, (5) interpersonal skills, (6) relaxation, physical exercise and lifestyle modification, (7) problem solving and (8) expressive writing and forgiveness, (9) positive psychology and (10) dreamwork and emotion-focus interventions. The ten modules are framed by one introductory and one summary module. Communication is carried out online via simulated dialogues. Patients have to respond to narrative text messages from the virtual therapists in multiple-choice response fashion, enabling them to express doubt, to affirm a particular message or to request more information. Text messages are aided with drawings, photographs and animations. The program is adaptive and selects exercises and contents on the basis of the subject's response. The modules are sequential and each module refers and builds upon previous one. Modules can (and should be) repeated within the intervention period.

Conditions

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Depression

Keywords

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Depression Online-Therapy Deprexis Self-help

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Wait-list group

Subjects receive access to deprexis after eight weeks

Group Type ACTIVE_COMPARATOR

Wait-list

Intervention Type BEHAVIORAL

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

Deprexis

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.

Group Type EXPERIMENTAL

Deprexis

Intervention Type BEHAVIORAL

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

Interventions

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Deprexis

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

Intervention Type BEHAVIORAL

Wait-list

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

Intervention Type BEHAVIORAL

Other Intervention Names

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web-based treatment program for depression web-based treatment for depression after 8 weeks

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steffen Mortz, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

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University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Countries

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Germany

Related Links

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http://www.deprexis.com

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

Other Identifiers

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Deprexis

Identifier Type: -

Identifier Source: org_study_id