Translation and Development of an Online Self-help Intervention With Subsequent Feasibility Study

NCT ID: NCT02671929

Last Updated: 2017-10-30

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

PHASE2

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-07-31

Brief Summary

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The purpose of this study is to determine the feasibility and effectiveness of an internet-based self help program concerning satisfaction with the treatment and their life, depression and anxiety. Both study groups get access to the internet-based self-help program. The intervention group receives additional feedback to their progress in the program from an online therapist. The investigators hypothesize that (1) at least 75% of the patients in the intervention group are "satisfied" or "very satisfied" with the self-help program, (2) 50% of the patients in the intervention group work with all eight units and (3) patients of the intervention group have a higher emotional competence than the patients of the control group at the end of the self-help program.

Detailed Description

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Conditions

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Treatment Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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self-help program + feedback

Patients in this arm receive access to the internet-based self-help program and get feedback on their progress in the program.

Group Type EXPERIMENTAL

self-help program

Intervention Type BEHAVIORAL

Access to the internet-based self-help program

therapeutic feedback

Intervention Type BEHAVIORAL

Therapeutic feedback on the written information sent to the online therapist

self-help program

Patients in this arm receive access to the internet-based self-help program and don't get any therapeutic feedback

Group Type ACTIVE_COMPARATOR

self-help program

Intervention Type BEHAVIORAL

Access to the internet-based self-help program

Interventions

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self-help program

Access to the internet-based self-help program

Intervention Type BEHAVIORAL

therapeutic feedback

Therapeutic feedback on the written information sent to the online therapist

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* day care/ inpatient treatment in the Department of Psychosomatic Medicine and Psychotherapy at the University Medical Center of the Johannes Gutenberg-University Mainz
* minimum age of 18 years
* private internet access
* e-mail address

Exclusion Criteria

* acute suicidality
* psychosis
* current alcohol or drug addiction
* life time diagnosis of a schizophrenic, schizoaffective, bipolar or organic psychic disorder
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Dr. RĂ¼diger Zwerenz

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manfred E Beutel, Prof. Dr.

Role: STUDY_DIRECTOR

Department for Psychosomatic Medicine and Psychotherapy at the University Medical Center of the Johannes Gutenberg-University Mainz

Locations

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University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University

Mainz, Rhineland-Palatinate, Germany

Site Status

Countries

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Germany

References

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Zwerenz R, Becker J, Johansson R, Frederick RJ, Andersson G, Beutel ME. Transdiagnostic, Psychodynamic Web-Based Self-Help Intervention Following Inpatient Psychotherapy: Results of a Feasibility Study and Randomized Controlled Trial. JMIR Ment Health. 2017 Oct 16;4(4):e41. doi: 10.2196/mental.7889.

Reference Type BACKGROUND
PMID: 29038094 (View on PubMed)

Other Identifiers

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RK-91809

Identifier Type: -

Identifier Source: org_study_id