Treatment SatisfactionPhase 2KENNCT02671929

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

A Phase 2 study testing self-help program and therapeutic feedback in people with Treatment Satisfaction, run by Johannes Gutenberg University Mainz at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Treatment Satisfaction
What is being tested?: self-help program and therapeutic feedback
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 83 participants
Where: 1 siteGermany
Study dates: Sep 2015to Jul 2016
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University
Mainz, Rhineland-Palatinate, 55131

Other trials in Germany

About this study

Official title: Translation and Development of an Online Self-help Intervention With Subsequent Feasibility Study as an After Care After Inpatient Psychosomatic Treatment

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.

Conditions: Treatment Satisfaction
Being tested: self-help program, therapeutic feedback

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

self-help programBehavioural
Access to the internet-based self-help program
therapeutic feedbackBehavioural
Therapeutic feedback on the written information sent to the online therapist

Study groups in NCT02671929
Study group	Role	What they receive
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. Receives: Behavioral: self-help program; Behavioral: 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 Receives: Behavioral: self-help program

What is being measured

The primary outcome is the main question the study is designed to answer.

Satisfaction of the intervention group with the internet-based self-help program measured with an reworded version of the "patient satisfaction questionnaire" (ZUF-8)
Measured: 10 weeks after study inclusion (T1)

Secondary outcomes (12)

Emotional competence measured with the "SEK-27" (questionnaire for self-assessment of emotional competence)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
Somatoform afflictions measured with the German version of the "SSS-8" (Somatic Symptom Scale)
Measured: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
Subjective prognosis of work ability measured with the "SPE" (Subjective Prognosis of Work Ability)
Measured: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
Therapeutic alliance measured with the German version of the "WAI-SR" (Working Alliance Inventory - Short Revised)
Measured: 10 weeks after study inclusion (T1)
Depersonalisation measured with the German short version of the "CDS-2" (Cambridge Depersonalisation Scale)
Measured: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
Acceptance of the internet-based self-help program measured with an especially for the self-help program devised questionnaire
Measured: End of every unit (weekly) and 10 weeks after study inclusion (T1)
Usage of the internet-based self-help program measured with an especially for the self-help program devised questionnaire
Measured: 10 weeks after study inclusion (T1)
Utilization of alternative after care measures (psychotherapy and drugs) with a self-devised questionnaire
Measured: 10 weeks after study inclusion (T1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Jul 2016

First posted2 Feb 2016 (estimated)
Study startSep 2015
Primary completionMay 2016
Study completionJul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Treatment SatisfactionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02671929
Sponsor's protocol ID: RK-91809
Acronym: KEN
Status last verified: Oct 2017
First submitted: 15 Jan 2016
Last updated: 30 Oct 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 29038094

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Translation and Development of an Online Self-help Intervention With Subsequent Feasibility Study as an After Care After Inpatient Psychosomatic Treatment
ClinicalTrials.gov ID: NCT02671929
Acronym / sponsor ID: KEN / RK-91809
Conditions: Treatment Satisfaction
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: Johannes Gutenberg University MainzUniversity, hospital or other
Study start: Sep 2015
Primary completion: May 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 2 Feb 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
self-help program + feedback	Experimental	Behavioral: self-help program, Behavioral: therapeutic feedbackPatients in this arm receive access to the internet-based self-help program and get feedback on their progress in the program.
self-help program	Active comparator	Behavioral: self-help programPatients in this arm receive access to the internet-based self-help program and don't get any therapeutic feedback

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
self-help programAccess to the internet-based self-help program	Behavioural	self-help program, self-help program + feedback
therapeutic feedbackTherapeutic feedback on the written information sent to the online therapist	Behavioural	self-help program + feedback

Primary outcome

Satisfaction of the intervention group with the internet-based self-help program measured with an reworded version of the "patient satisfaction questionnaire" (ZUF-8)
Time frame: 10 weeks after study inclusion (T1)

12 secondary outcomes

Emotional competence measured with the "SEK-27" (questionnaire for self-assessment of emotional competence)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
Somatoform afflictions measured with the German version of the "SSS-8" (Somatic Symptom Scale)
Time frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
Subjective prognosis of work ability measured with the "SPE" (Subjective Prognosis of Work Ability)
Time frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
Therapeutic alliance measured with the German version of the "WAI-SR" (Working Alliance Inventory - Short Revised)
Time frame: 10 weeks after study inclusion (T1)
Depersonalisation measured with the German short version of the "CDS-2" (Cambridge Depersonalisation Scale)
Time frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
Acceptance of the internet-based self-help program measured with an especially for the self-help program devised questionnaire
Time frame: End of every unit (weekly) and 10 weeks after study inclusion (T1)
Usage of the internet-based self-help program measured with an especially for the self-help program devised questionnaire
Time frame: 10 weeks after study inclusion (T1)
Utilization of alternative after care measures (psychotherapy and drugs) with a self-devised questionnaire
Time frame: 10 weeks after study inclusion (T1)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
Background: PubMed 29038094Zwerenz 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Manfred E Beutel, Prof. Dr. study director

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing self-help program and therapeutic feedback in people with Treatment Satisfaction, run by Johannes Gutenberg University Mainz at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Satisfaction of the intervention group with the internet-based self-help program measured with an reworded version of the "patient satisfaction questionnaire" (ZUF-8) (time frame: 10 weeks after study inclusion (T1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02671929, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2017.