RTW-PIA - Intensified Return to Work (RTW) aftercare in psychiatric outpatient clinics of psychiatric hospitals
Organizational Data
- DRKS-ID:
- DRKS00026232
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2021-09-01
- Last update in DRKS:
- 2023-11-24
- Registration type:
- Prospective
Acronym/abbreviation of the study
RTW-PIA
URL of the study
Brief summary in lay language
Mental health problems have significant economic and health political consequences. They involve a high risk of relapse and chronicity and represent one of the most frequent causes for sick leave and early retirement. At the intersection of the mental healthcare system and the workplace, a coordinated and harmonised approach can promote a stable, sustainable return to work (RTW) after a mental disorder. It can also reduce renewed prolonged absence periods due to sickness, as well as the risk of reduced earning capacity through improved relapse prevention. The majority of RTW-research on people with mental health disorders has focused primarily on the time until RTW but only few papers have studied the time during as well as after RTW. Therefore, the effectiveness of an intensified RTW support and aftercare in psychiatric outpatient clinics (ger: Psychiatrische Institutsambulanzen [PIAs]) of psychiatric hospitals will be examined through a multicentre, randomized controlled trial. The focus is on maintaining and restoring the workability and earning capacity of employees with mental health problems in terms of a sustainable RTW. The study is funded by the Innovation Fund of the Federal Joint Committee (Gemeinsamer Bundesausschuss [G-BA]) for a period of four years [Project ID: 01NVF19010]. The Hannover Medical School is the consortium leader. BAuA is responsible for the quantitative and qualitative effectiveness - and process evaluation. A health economic evaluation will be conducted by the project partner from the Friedrich-Alexander University Erlangen-Nürnberg. In case of a positive evaluation, there is a prospect of transferring the intensified RTW PIA aftercare to regular care.
Brief summary in scientific language
The present quantitative efficacy evaluation is designed as a two-arm multicentre, 1:1 randomised controlled trial (RCT) in which an intervention group (IG) “RTW-PIA” will be compared to a control group (CG) “PIA as usual” with 506 participants in total. In addition, qualitative before-and-after interviews are planned to be carried out with a sub-sample of 30 people at a ratio of 2: 1 (IG:CG). The recruitment and implementation of the interventions will take place in five different german psychiatric outpatient clinics of psychiatric hospitals. The primary aim of this study is to evaluate the effectiveness of "RTW-PIA" intervention versus standard care "PIA as usual" in terms of the achievement of a sustainable return to work among employees with symptoms of CMD. In addition, it will be evaluated which participant groups benefit most from the new form of care “RTW-PIA” and for what reasons. Furthermore, it will be determined whether the new form of care “RTW-PIA” is superior to the existing standard care in terms of the cost-benefit ratio. Within the participating psychiatric outpatient clinics (ger: Psychische Institutsambulanz, abbrev.: PIA), the control group "PIA as usual" receives standard care which is needs-oriented and not specifically devoted to the subjects of RTW. Thus, standard care only focuses on the treatment of the mentally ill patients. On the other hand, the intervention group "RTW-PIA" receives besides standard care an additional new form of care which combines three sequential modules. The modules will be initiated and implemented by the PIAs during the study participant´s clinical treatment and throughout their RTW at the company: RTW consultation and coaching, RTW aftercare groups and accompanying web-based aftercare. Furthermore, quantiative data will be collected from both participant groups at five timepoints: baseline (t0), after 6 months (t1), 12 months (t2), 18 months (t3) and 24 months (t4). The quantitative survey times are used to obtain regular information from the study participant´s return, its process and how they stay at work in a sustainable way. Furthermore, a total of 20 participants from the IG and 10 participants from the CG will be asked to participate in qualitative before-and-after interviews which are held at t0 and t3.
Health condition or problem studied
- ICD10:
- F20-F29 - Schizophrenia, schizotypal and delusional disorders
- ICD10:
- F30-F39 - Mood [affective] disorders
- ICD10:
- F40-F48 - Neurotic, stress-related and somatoform disorders
- ICD10:
- F50-F59 - Behavioural syndromes associated with physiological disturbances and physical factors
- ICD10:
- F60-F69 - Disorders of adult personality and behaviour
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Besides receiving standard care, study participants of the intervention group will be offered a new form of care which combines the following three sequential modules that are initiated and implemented by the PIAs during the clinical treatment as well as throughout RTW at the company: - RTW-consultation hours and RTW-coaching: participants may take up to eight private sessions for professional guidance during their reintegration process. - RTW-aftercare-group treatment: Six up to a maximum of nine group meetings will be offered to the participants of the intervention group, in which an exchange of experiences with other affected persons can take place. Within the group sessions, problems returning to work and general strategies, e.g. for coping with stress, can be discussed - Webbased aftercare: The long-term RTW will be accompanied by a web-based program that is primarily intended to support the study participant´s personal self-care. This is a digital health application made available by the provider "minddistrict". The study participants can use the digital health application continuously over a period of around 12 months.
- Arm 2:
- The control group "PIA as usual" receives standard care within the participating psychiatric outpatient clinics, which is needs-oriented and not specifically devoted to the subjects of RTW. Thus, standard care only focuses on the treatment of the mentally ill patients. As part of standard care, participants of the control group will have access to regular therapeutic discussions within the PIA. Depending on the participants needs, the treatment is normally carried out by a multi-professional team (e.g. doctors, social workers, psychologists). During the study participation, it is not possible for those of the control group to receive any other psychiatric treatment from practitioners outside of the PIA.
Endpoints
- Primary outcome:
- Sustainable Return to Work, defined as a "twelve-month stay at work period without longer sick leave periods of > 6 weeks within the last 12 months after first returning to work" (self-developed, in accordance with TiC-P instrument (Treatment Inventory of Costs in Patients with psychiatric disorders))
- Secondary outcome:
- - Occurrence of a relapse based on sympton severity (BSI-18=Brief Symptom Inventory) - Work ability (Work-Ability-Scale) - Functionality (NFAS=Norwegian Function Assessment Scale) -RTW Self-Efficacy (RTW-SE=Return To Work-Self Efficacy Scale) - Health-related quality of life (AQoL-6D=Assessment of Quality of Life - 6D scale) - Job satisfaction (COPSOQ=Copenhagen Psychosocial Questionnaire) - Utilisation of medical services (TiC-P=Treatment Inventory of Costs in Patients with psychiatric disorders) At 5 different timepoints, study participants will be asked to respond to a six month interval-online survey.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Medical center Klinik Wittgenstein Bad Berleburg
- Medical center Alexianer St. Joseph Klinikum Berlin-Weißensee (Klinik für Psychiatrie, Psychotherapie und Psychosomatik) Berlin
- Medical center Burghof-Klinik Rinteln (Klinik für Psychiatrie, Psychosomatik und Psychotherapie) Rinteln
- Medical center Asklepios-Klinikum Harburg (Zentrum für seelische Gesundheit) Hamburg
- University medical center Medizinische Hochschule Hannover (Klinik für Psychiatrie, Sozialpsychiatrie und Psychotherapie) Hannover
Recruitment period and number of participants
- Planned study start date:
- 2021-09-30
- Actual study start date:
- 2021-09-30
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 506
- Final Sample Size:
- 484
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 60 Years
- Additional Inclusion Criteria:
- (1) aged between 18 and 60 years, (2) employment with at least 15 hours per week on the primary labour market, (3) at least 6 weeks of current incapacity for work, (4) inpatient, day-care or outpatient treatment within a care hospital´s psychiatric institutional outpatient department due to a currently diagnosed mental disorder (ICD-10; World Health Organization, 2004) from F20 to F69, (5) fulfilment of the other entrance criteria into the psychiatric outpatient clinics of psychiatric hospitals, formulated in section 118 of Book V of the German Social Security Code (SBG V) (with respect to the clinic´s criteria regarding type, severity and duration of illness)
Exclusion Criteria
(1) single or main diagnosis of organic psychiatric disorders (F00-F09) and substance abuse (F10-19) (2) acute severe somatic disease (3) present pregnancy (4) conscious decision against returning to job market (5) already planned, approved and prepared rehabilitation
Addresses
Primary Sponsor
- Address:
- Medizinische Hochschule HannoverCarl-Neuberg-Str. 130625 HannoverGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.mh-hannover.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Medizinische Hochschule HannoverDr. Gregor Rafael SzycikCarl-Neuberg-Str. 130625 HannoverGermany
- Telephone:
- 0511 532-7362
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.mh-hannover.de
Contact for Public Queries
- Address:
- Medizinische Hochschule HannoverCarl-Neuberg-Str. 130625 HannoverGermany
- Telephone:
- 0511 532-7362
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.mh-hannover.de
Principal Investigator
- Address:
- Medizinische Hochschule HannoverDr. Gregor Rafael SzycikCarl-Neuberg-Str. 130625 HannoverGermany
- Telephone:
- 0511 532-7362
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.mh-hannover.de
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Innovationsausschuss beim G-BAPostfach 12 06 0610596 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Hochschule HannoverCarl-Neuberg-Str. 130625 HannoverGermany
- Telephone:
- +49-511-5323443
- Fax:
- +49-511-5325423
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-07-28
- Ethics committee number:
- 9824_BO_S_2021
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-08-13
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- Starke, F., Sikora, A., Stegmann, R. et al. Evaluating a multimodal, clinical and work-directed intervention (RTW-PIA) to support sustainable return to work among employees with mental disorders: study protocol of a multicentre, randomised controlled trial. BMC Psychiatry 23, 380 (2023). https://doi.org/10.1186/s12888-023-04753-5
- PDF: Starke, F., Sikora, A., Stegmann, R. et al. Evaluating a multimodal, clinical and work-directed intervention (RTW-PIA) to support sustainable return to work among employees with mental disorders: study protocol of a multicentre, randomised controlled trial. BMC Psychiatry 23, 380 (2023). https://doi.org/10.1186/s12888-023-04753-5
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry