NCT02671929

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

October 30, 2017

Status Verified

October 1, 2017

Enrollment Period

8 months

First QC Date

January 15, 2016

Last Update Submit

October 27, 2017

Conditions

Treatment Satisfaction

Outcome Measures

Primary Outcomes (1)

  • Satisfaction of the intervention group with the internet-based self-help program measured with an reworded version of the "patient satisfaction questionnaire" (ZUF-8)

    10 weeks after study inclusion (T1)

Secondary Outcomes (12)

  • Emotional competence measured with the "SEK-27" (questionnaire for self-assessment of emotional competence)

    10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)

  • Depression measured with the German version of the "PHQ-9" (Patient Health Questionnaire)

    10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)

  • Quality of life measured with the German version of the "EUROHIS-QOL 8" (European Health Interview Survey Quality of Life 8)

    10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)

  • Anxiety measured with the German version of the "GAD-7" (General Anxiety Disorder Screener)

    10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)

  • Self-esteem measured with the German version of the "RSE" (Rosenberg Self-Esteem Scale)

    10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)

  • +7 more secondary outcomes

Study Arms (2)

self-help program + feedback

EXPERIMENTAL

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

Behavioral: self-help programBehavioral: therapeutic feedback

self-help program

ACTIVE COMPARATOR

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

Behavioral: self-help program

Interventions

self-help programBEHAVIORAL

Access to the internet-based self-help program

self-help programself-help program + feedback
therapeutic feedbackBEHAVIORAL

Therapeutic feedback on the written information sent to the online therapist

self-help program + feedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Related Publications (1)

  • 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.

    PMID: 29038094BACKGROUND

Study Officials

  • Manfred E Beutel, Prof. Dr.

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 15, 2016

First Posted

February 2, 2016

Study Start

September 1, 2015

Primary Completion

May 1, 2016

Study Completion

July 1, 2016

Last Updated

October 30, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)