Plain English Summary
Background and study aims
Schizophrenia is a severe mental illness with a high risk of relapse. Following discharge from inpatient or day hospital psychiatric treatment, patients are confronted with the challenges of daily life and the management of their illness. Continuous support is important during this period, yet challenging to implement as part of routine mental healthcare. The aftercare intervention HEINS is delivered via mobile phones and internet and provides continuous low-threshold support to patients following their discharge from inpatient or day hospital treatment. In case of symptoms becoming worse, more intense professional support is offered to participants. It is expected that participation in the aftercare intervention has positive effects on patients’ well-being and on their utilization of mental healthcare services following their discharge from the hospital. Overall, the study’s findings should help to improve the continuity of care for patients with schizophrenia.
Who can participate?
Adult patients discharged from treatment for schizophrenia, schizotypal, or delusional disorder at the Department of General Psychiatry, University Hospital Heidelberg, Germany. Participation in the study requires that patients undergo treatment as usual following their discharge from the hospital (i.e., they have to have an outpatient mental healthcare provider). Furthermore, participation requires that patients have access to the Internet, possess a mobile phone, and have sufficient knowledge of the German language.
What does the study involve?
Participants are randomly assigned to one of two groups, i.e. either they receive treatment as usual or they receive treatment as usual plus participation in the aftercare intervention HEINS which is delivered via Internet and mobile phone for six months. HEINS is made up of several modules, i.e., psychoeducation, an individualized crises plan, and counselling via chat and/or telephone. The central module is a monitoring and feedback system. Once a week, participants answer a short questionnaire on their adherence to medication, sleep, anxiety, social contacts, and well-being via their mobile phone. Participants receive an automated feedback message referring to their current status and changes. In case of severe impairment participants are contacted by the hospital in order to evaluate the situation and provide further support if necessary.
What are the possible benefits and risks of participating?
The intervention aims at strengthening self-management competencies, and the detection of early warning signs in order to prevent relapses and counteract deteriorations as early as possible. There are no known risks associated with participation.
Where is the study run from?
Center for Psychotherapy Research and the Department of General Psychiatry at the University Hospital Heidelberg (Germany).
When is the study starting and how long is it expected to run for?
July 2015 to April 2016
Who is funding the study?
Center for Psychotherapy Research, University Hospital Heidelberg (Germany)
Who is the main contact?
Dr Stephanie Bauer
stephanie.bauer@med.uni-heidelberg.de
Trial website
Contact information
Type
Scientific
Primary contact
Dr Stephanie Bauer
ORCID ID
Contact details
Center for Psychotherapy Research
University Hospital Heidelberg
Bergheimer Str. 54
Heidelberg
69115
Germany
00496221567345
stephanie.bauer@med.uni-heidelberg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Is an aftercare intervention delivered via mobile phones and internet a feasible add-on to treatment as usual for patients with schizophrenia?
Acronym
HEINS
Study hypothesis
1. The intervention HEINS is well-accepted by the target population
2. The assessments and procedures prove to be feasible
3. Participation in HEINS yields to improved well-being six months after discharge from inpatient treatment compared to TAU
4. Participation in HEINS yields to improved service utilization in case of crisis within six months after discharge from inpatient treatment compared to TAU
Ethics approval
Ethikkommission der Medizinischen Fakultät Heidelberg [Ethics Committee of the Faculty of Medicine, University of Heidelberg], 01/06/2015, ref: S-147/2015
Study design
Prospective single center randomized controlled trial; Pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Schizophrenia, schizotypal, and delusional disorders; ICD-10 Categories F20-F29
Intervention
All patients undergo treatment at the Department of General Psychiatry at the University Hospital Heidelberg. Prior to discharge patients are randomized to one of two arms:
1. TAU (Treatment as usual): Patients in the TAU condition undergo the standard outpatient follow-up treatment, provided by an outpatient psychiatrist or the outpatient unit of the Department of General Psychiatry.
2. TAU plus HEINS (“Heidelberger Nachsorgeprogramm fuer Schizophrenie / Heidelberg aftercare program for schizophrenia”): HEINS is an aftercare program based on mobile phone and Internet technology. The intervention comprises several modules, i.e., psychoeducation, an individualized crises plan, and counselling via chat and/or telephone. The central module is a monitoring and feedback system. Once a week, participants answer a short questionnaire on their adherence to medication, sleep, anxiety, social contacts, and well-being via their mobile phone. Participants receive an automated feedback message referring to their current status and changes. In case of severe impairment participants are contacted by the hospital in order to evaluate the situation and provide further support if necessary. The duration of participation in HEINS is six months.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Willingness to participate: The proportion of the target population willing to participate in the study
2. Adherence: Utilization of HEINS modules and rate of drop-out from the intervention
3. Attitudes, expectations, and satisfaction: Attitudes and expectations towards Internet-based interventions at the beginning of participation and satisfaction with HEINS at the end of participation
Secondary outcome measures
1. Feasibility of assessment instruments (questionnaires and interviews)
2. Feasibility of procedures and external randomization
3. Intervention effects on well-being six months after discharge from hospital (measured with the Positive and Negative Syndrome Scale; PANSS)
4. Intervention effects on service utilization within six months after discharge from hospital (measured with the Longitudinal Follow-up Evaluation; LIFE)
Overall trial start date
01/01/2015
Overall trial end date
31/12/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. ICD-10 Diagnosis Categories F20-F29 (Schizophrenia, schizotypal and delusional disorders)
2. Inpatient or day hospital treatment at the University Hospital Heidelberg, Department of General Psychiatry
3. Outpatient follow-up treatment provided by an outpatient provider or the outpatient unit of the Department of General Psychiatry
4. Age: at least 18 years old
5. Sufficient German language skills
6. Mobile phone
7. Access to the Internet
8. Capability to give informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Dependence syndrome (except tacacco) in the last 2 years
2. Severe craniocerebral injury
3. Acute psychotic disorder with a duration of less than 4 weeks
Recruitment start date
15/07/2015
Recruitment end date
15/04/2016
Locations
Countries of recruitment
Germany
Trial participating centre
Department of General Psychiatry
University Hospital Heidelberg
Voßstr. 2
Heidelberg
69115
Germany
Sponsor information
Organisation
Center for Psychotherapy Research
Sponsor details
Bergheimer Str. 54
Heidelberg
69115
Germany
Sponsor type
University/education
Website
Funders
Funder type
Not defined
Funder name
Center for Psychotherapy Research, University Hospital Heidelberg (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
31/12/2016
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list