Psychosomatic DisorderNCT04989842
Effectiveness and Equivalence of an Internet-based Virtual Classroom Intervention for Psychosomatic Aftercare
A study testing Curriculum Hannover in people with Psychosomatic Disorder and Mental Disorder, run by Dr. Becker Hospital Group at 1 site in Germany.
Trial summary
Outpatient psychosomatic aftercare after inpatient rehabilitation pursues the goal of helping patients to transfer the achieved rehabilitation result in everyday life and professional life. The Hanover Curriculum has been established as a treatment programme for psychosomatic aftercare. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Psychosomatic Disorder, Mental Disorder
- What is being tested?
- Curriculum Hannover
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,023 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2017to 31 Dec 2021
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients after psychosomatic rehabilitation
- indication for outpatient psychosomatic aftercare are included in both studies.
- access to a standard PC and broadband internet connection is required (DSL or LTE).
Who cannot join
- Persons who are
- are discharged with a capacity of less than three hours per day on the general labour market,
- receive or have applied for a pension of at least two-thirds of the full pension,
- receive a benefit that is regularly paid until the start of an old-age pension.
- suffering from acute addiction disorder / acute psychosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Studies on the Effectiveness and Equivalence of an Internet-based Virtual Classroom Intervention for Psychosomatic Aftercare According to the Hannover Curriculum
Outpatient psychosomatic aftercare after inpatient rehabilitation pursues the goal of helping patients to transfer the achieved rehabilitation result in everyday life and professional life. The Hanover Curriculum has been established as a treatment programme for psychosomatic aftercare. This comprises 25 weekly group sessions and two single therapies at the beginning and at the end of the therapy.
In Germany a vast majority of rehabilitants in a psychosomatic rehabilitation clinic has an indication for psychosomatic aftercare, but it is used only by less than half of the patients due to a lack of aftercare therapists. If there is a therapist in the patient's vicinity, there are often long travelling times to the therapist or the patients might feel stigmatized participating in a face-to-face therapy.
Read more
Thus, the expansion of internet-based aftercare services is recommended. Advantages are that they can be carried out at home, possible cost and time savings and improvement of the care situation.
Several meta-analyses provide high evidence for the effectiveness of internet-based therapy offers in depressive and anxiety disorders that are frequent among psychosomatic rehabilitation patients. First randomised controlled studies show that internet-based aftercare services can lead to a symptomatic improvement and to a reduction of relapses. It is currently not clear whether established aftercare concepts, such as the Curriculum Hannover, are also effective in an internet-based format (Curriculum Hannover Online).
The present project consists of a superiority study, examining whether participation in Curriculum- Hannover-Online leads to a stronger adoption and maintenance of the health improvements achieved in inpatient rehabilitation in comparison to care as usual, and an equivalnece study, examining, wether the Curriculum Hannover Online is an equivalent treatment option to the existing face-to-face aftercare therapy.
Read the detailed description
The use of information and communication technology with the aim of promoting mental health can be described as "e-Mental Health", which is regularly used synonymously with the term "internet-based interventions".
With regard to the study situation on internet-based aftercare interventions, especially in Germany, the research is in an early phase. An overview of the possible uses of internet-based treatment approaches in rehabilitation can be found in Lin, Ebert, Lehr, Berking and Baumeister (2013) and - based on the contributions of the Rehabilitation Science Colloquium since 2008 - Baumeister, Lin and Ebert (2013). However, the first randomised controlled studies on aftercare show, in agreement with the studies outlined above, that corresponding offers led to a reduction in relapses compared to Care as Usual (CAU) (Bauer, Okon, Meermann, Kordy, 2013; Ebert, Tarnowski, Gollwitzer, Sieland\& Berking, 2013).Both interventions represent new conceptual developments. Regarding the positive findings on the effectiveness of internet-based interventions and with a view to the suboptimal care situation, Kobelt, Winkler and Petermann (2011), for example, recommend the expansion of internet-based aftercare services and their evaluation.
The planned project aims to develop an internet-based variant of the aftercare concept Curriculum Hannover (Curriculum-Hannover-Online), to integrate it into routine care and to test its effectiveness. The technology of the virtual classroom is particularly suitable for internet-based interventions providing group therapy (cf. Wolever et al., 2012).
For this purpose, the existing manual for Curriculum Hannover (cf. Kobelt et al., 2002) is adapted in the course of the process for the needs of an online intervention. The therapists will be prepared for the specifics of the medium through a train-the-trainer-training for learning how to specifically establish and maintain a therapeutic relationship between therapist and participants. It is assumed that this new program for outpatient aftercare after inpatient psychosomatic rehabilitation can be an effective and useful therpy for patients who do not have access to the existing face-to-face aftercare therapies.. The Virtual Classroom is a direct, video- or audio-synchronous and multimedia contact between therapist and patient.
The main question of the superiority study is:
- Does participation in the Curriculum-Hannover-Online lead to improved uptake and maintenance of the health improvements achieved in inpatient rehabilitation? B. Can the implementation of the Curriculum-Hannover-Online be designed in such a way that its use as a routine procedure in rehabilitation can be recommended? C. Can the Curriculum-Hannover-Online be accepted by the relevant stakeholders to the same extent as the face-to-face version of the Curriculum-Hannover-Online? For the successful introduction of a new treatment approach, in addition to the proof of its effectiveness, significant challenges have to be overcome with regard to the organisation of work processes, the involvement of all actors involved in the process (especially patients, practitioners, management).
The main question of the equivalence study is:
A.Does participation in the Curriculum-Hannover-Online lead to an equivalent adoption and maintenance of the health improvements achieved in inpatient rehabilitation? B. Can the implementation of the Curriculum-Hannover-Online in addition to the offer of the face-to-face variant be designed in such a way that its use as a rou- tine procedure in rehabilitation can be recommended? C.Can the Curriculum-Hannover-Online be accepted by the relevant stakeholders to the same extent as the face-to-face version of the Curriculum-Hannover-Online? D.Can characteristics be identified that allow a differential indication for the recommendation to participate in the Curriculum Hannover in its online or face-to-face variant? E.What are the additional advantages of the Curriculum Hannover Online from the perspective of patients, therapists, service providers and health care providers? Both studies will be conducted as two-arm randomised controlled trials. Individual rehabilitation patients will be randomised to the respective study arms. The system is based on a randomisation list (permuted blocks of variable length) with the help of the "Randlist" software at the sites. The order of the completed questionnaires determines the position in the list.
All data of the participants will be treated in accordance with the data security regulations (DSGVO), good scientific practice and the ethical requirements. Furthermore, all patients are informed about the project, ethics and data protection in a generally understandable way by a cover letter from their clinic before the treatment. All project staff are obliged to comply with the ethics guidelines and to maintain confidentiality. The pre- and post-data of the patients are combined by means of a personal code, which does not allow any conclusion about the participant.
- Conditions
- Psychosomatic Disorder, Mental Disorder
- Being tested
- Curriculum Hannover
- Keywords
- Rehabilitation, Psychosomatics, Aftercare, webbased aftercare therapy
- Medical subject headings
- Psychophysiologic Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curriculum HannoverBehavioural
The methodology uses a natural variation design within the Dr. Becker Clinical Group. The interventions consist of a face-to-face or a digital psychosomatic aftercare basing upon the concept of the Curriculum Hanover. A control group is included that does not receive these two interventions (but receives a similar rehabilitation treatment to the intervention groups).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group 1 | Active comparator | webbased aftercare Receives: Behavioral: Curriculum Hannover |
| Control group | No intervention | care as usual |
| Intervention group 2 | Active comparator | webbased aftercare Receives: Behavioral: Curriculum Hannover |
| face-to-face aftercare | Active comparator | face-to-face aftercare Receives: Behavioral: Curriculum Hannover |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of psychic and somatoform complaints
according to the HEALTH-49 (Rabung et al., 2009)
Measured: up to 18 months
Secondary outcomes (11)
change of depressiveness
according to the HEALTH-49 (Rabung et al., 2009)
Measured: up to 18 months
change of phobic anxiety
according to the HEALTH-49 (Rabung et al., 2009)
Measured: up to 18 months
change of somatoform complaints
according to the HEALTH-49 (Rabung et al., 2009)
Measured: up to 18 months
change of mental well-being
according to the HEALTH-49 (Rabung et al., 2009)
Measured: up to 18 months
change of interactional difficulties
according to the HEALTH-49 (Rabung et al., 2009)
Measured: up to 18 months
change of self-efficacy
according to the HEALTH-49 (Rabung et al., 2009)
Measured: up to 18 months
change of activity and participation
according to the HEALTH-49 (Rabung et al., 2009)
Measured: up to 18 months
change of social support
according to the HEALTH-49 (Rabung et al., 2009)
Measured: up to 18 months
change of social stress
according to the HEALTH-49 (Rabung et al., 2009)
Measured: up to 18 months
change of employment prognosis
according to the subjective employment forecast (Mittag et al.,2006)
Measured: up to 18 months
change of workability
according to the work ability index (Hasselhorn\&Freude, 2007)
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start1 Mar 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Psychosomatic DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,023 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Becker Hospital Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Alina Dahmen, Dr. Becker Hospital Group
- Investigators
- Alina Dahmen, MD, Study director, Dr. Becker Hospital Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989842
- Sponsor's protocol ID
- Curriculum Hannover Online
- Status last verified
- May 2022
- First submitted
- 14 Jul 2021
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be published. Other researchers are welcome to get in contact with the PI to get access to anonymous data.
Publications
Andersson G, Cuijpers P, Carlbring P, Riper H, Hedman E. Guided Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: a systematic review and meta-analysis. World Psychiatry. 2014 Oct;13(3):288-95. doi: 10.1002/wps.20151.
PubMed 25273302Arnberg FK, Linton SJ, Hultcrantz M, Heintz E, Jonsson U. Internet-delivered psychological treatments for mood and anxiety disorders: a systematic review of their efficacy, safety, and cost-effectiveness. PLoS One. 2014 May 20;9(5):e98118. doi: 10.1371/journal.pone.0098118. eCollection 2014.
PubMed 24844847Cheng SK, Dizon J. Computerised cognitive behavioural therapy for insomnia: a systematic review and meta-analysis. Psychother Psychosom. 2012;81(4):206-16. doi: 10.1159/000335379. Epub 2012 May 11.
PubMed 22585048Cuijpers P, van Straten A, Warmerdam L, van Rooy MJ. Recruiting participants for interventions to prevent the onset of depressive disorders: possible ways to increase participation rates. BMC Health Serv Res. 2010 Jun 25;10:181. doi: 10.1186/1472-6963-10-181.
PubMed 20579332Cuijpers P, Marks IM, van Straten A, Cavanagh K, Gega L, Andersson G. Computer-aided psychotherapy for anxiety disorders: a meta-analytic review. Cogn Behav Ther. 2009;38(2):66-82. doi: 10.1080/16506070802694776.
PubMed 20183688Ebert DD, Lehr D, Boss L, Riper H, Cuijpers P, Andersson G, Thiart H, Heber E, Berking M. Efficacy of an internet-based problem-solving training for teachers: results of a randomized controlled trial. Scand J Work Environ Health. 2014 Nov;40(6):582-96. doi: 10.5271/sjweh.3449. Epub 2014 Aug 13.
PubMed 25121986Ebert D, Tarnowski T, Gollwitzer M, Sieland B, Berking M. A transdiagnostic internet-based maintenance treatment enhances the stability of outcome after inpatient cognitive behavioral therapy: a randomized controlled trial. Psychother Psychosom. 2013;82(4):246-56. doi: 10.1159/000345967. Epub 2013 Jun 1.
PubMed 23736751Haug T, Nordgreen T, Ost LG, Havik OE. Self-help treatment of anxiety disorders: a meta-analysis and meta-regression of effects and potential moderators. Clin Psychol Rev. 2012 Jul;32(5):425-45. doi: 10.1016/j.cpr.2012.04.002. Epub 2012 Apr 21.
PubMed 22681915Lin J, Ebert DD, Lehr D, Berking M, Baumeister H. [Internet based cognitive behavioral interventions: state of the art and implementation possibilities in rehabilitation]. Rehabilitation (Stuttg). 2013 Jun;52(3):155-63. doi: 10.1055/s-0033-1343491. Epub 2013 Jun 12. German.
PubMed 23761204Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. No abstract available.
PubMed 20332511Wolever RQ, Bobinet KJ, McCabe K, Mackenzie ER, Fekete E, Kusnick CA, Baime M. Effective and viable mind-body stress reduction in the workplace: a randomized controlled trial. J Occup Health Psychol. 2012 Apr;17(2):246-258. doi: 10.1037/a0027278. Epub 2012 Feb 20.
PubMed 22352291Richards D, Richardson T. Computer-based psychological treatments for depression: a systematic review and meta-analysis. Clin Psychol Rev. 2012 Jun;32(4):329-42. doi: 10.1016/j.cpr.2012.02.004. Epub 2012 Feb 28.
PubMed 22466510Lippke S, Gao L, Keller FM, Becker P, Dahmen A. Adherence With Online Therapy vs Face-to-Face Therapy and With Online Therapy vs Care as Usual: Secondary Analysis of Two Randomized Controlled Trials. J Med Internet Res. 2021 Nov 3;23(11):e31274. doi: 10.2196/31274.
PubMed 34730541
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies on the Effectiveness and Equivalence of an Internet-based Virtual Classroom Intervention for Psychosomatic Aftercare According to the Hannover Curriculum
- ClinicalTrials.gov ID
- NCT04989842
- Acronym / sponsor ID
- Curriculum Hannover Online
- Conditions
- Psychosomatic Disorder, Mental Disorder
- Keywords
- Rehabilitation, Psychosomatics, Aftercare, webbased aftercare therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,023 participants (actual)
- Lead sponsor
- Dr. Becker Hospital GroupUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 4 Aug 2021 (actual)
- 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.
Outpatient psychosomatic aftercare after inpatient rehabilitation pursues the goal of helping patients to transfer the achieved rehabilitation result in everyday life and professional life. The Hanover Curriculum has been established as a treatment programme for psychosomatic aftercare. This comprises 25 weekly group sessions and two single therapies at the beginning and at the end of the therapy.
In Germany a vast majority of rehabilitants in a psychosomatic rehabilitation clinic has an indication for psychosomatic aftercare, but it is used only by less than half of the patients due to a lack of aftercare therapists. If there is a therapist in the patient's vicinity, there are often long travelling times to the therapist or the patients might feel stigmatized participating in a face-to-face therapy.
Thus, the expansion of internet-based aftercare services is recommended. Advantages are that they can be carried out at home, possible cost and time savings and improvement of the care situation.
Several meta-analyses provide high evidence for the effectiveness of internet-based therapy offers in depressive and anxiety disorders that are frequent among psychosomatic rehabilitation patients. First randomised controlled studies show that internet-based aftercare services can lead to a symptomatic improvement and to a reduction of relapses. It is currently not clear whether established aftercare concepts, such as the Curriculum Hannover, are also effective in an internet-based format (Curriculum Hannover Online).
The present project consists of a superiority study, examining whether participation in Curriculum- Hannover-Online leads to a stronger adoption and maintenance of the health improvements achieved in inpatient rehabilitation in comparison to care as usual, and an equivalnece study, examining, wether the Curriculum Hannover Online is an equivalent treatment option to the existing face-to-face aftercare therapy.
Detailed description
The use of information and communication technology with the aim of promoting mental health can be described as "e-Mental Health", which is regularly used synonymously with the term "internet-based interventions".
With regard to the study situation on internet-based aftercare interventions, especially in Germany, the research is in an early phase. An overview of the possible uses of internet-based treatment approaches in rehabilitation can be found in Lin, Ebert, Lehr, Berking and Baumeister (2013) and - based on the contributions of the Rehabilitation Science Colloquium since 2008 - Baumeister, Lin and Ebert (2013). However, the first randomised controlled studies on aftercare show, in agreement with the studies outlined above, that corresponding offers led to a reduction in relapses compared to Care as Usual (CAU) (Bauer, Okon, Meermann, Kordy, 2013; Ebert, Tarnowski, Gollwitzer, Sieland\& Berking, 2013).Both interventions represent new conceptual developments. Regarding the positive findings on the effectiveness of internet-based interventions and with a view to the suboptimal care situation, Kobelt, Winkler and Petermann (2011), for example, recommend the expansion of internet-based aftercare services and their evaluation.
The planned project aims to develop an internet-based variant of the aftercare concept Curriculum Hannover (Curriculum-Hannover-Online), to integrate it into routine care and to test its effectiveness. The technology of the virtual classroom is particularly suitable for internet-based interventions providing group therapy (cf. Wolever et al., 2012).
For this purpose, the existing manual for Curriculum Hannover (cf. Kobelt et al., 2002) is adapted in the course of the process for the needs of an online intervention. The therapists will be prepared for the specifics of the medium through a train-the-trainer-training for learning how to specifically establish and maintain a therapeutic relationship between therapist and participants. It is assumed that this new program for outpatient aftercare after inpatient psychosomatic rehabilitation can be an effective and useful therpy for patients who do not have access to the existing face-to-face aftercare therapies.. The Virtual Classroom is a direct, video- or audio-synchronous and multimedia contact between therapist and patient.
The main question of the superiority study is:
- Does participation in the Curriculum-Hannover-Online lead to improved uptake and maintenance of the health improvements achieved in inpatient rehabilitation? B. Can the implementation of the Curriculum-Hannover-Online be designed in such a way that its use as a routine procedure in rehabilitation can be recommended? C. Can the Curriculum-Hannover-Online be accepted by the relevant stakeholders to the same extent as the face-to-face version of the Curriculum-Hannover-Online? For the successful introduction of a new treatment approach, in addition to the proof of its effectiveness, significant challenges have to be overcome with regard to the organisation of work processes, the involvement of all actors involved in the process (especially patients, practitioners, management).
The main question of the equivalence study is:
A.Does participation in the Curriculum-Hannover-Online lead to an equivalent adoption and maintenance of the health improvements achieved in inpatient rehabilitation? B. Can the implementation of the Curriculum-Hannover-Online in addition to the offer of the face-to-face variant be designed in such a way that its use as a rou- tine procedure in rehabilitation can be recommended? C.Can the Curriculum-Hannover-Online be accepted by the relevant stakeholders to the same extent as the face-to-face version of the Curriculum-Hannover-Online? D.Can characteristics be identified that allow a differential indication for the recommendation to participate in the Curriculum Hannover in its online or face-to-face variant? E.What are the additional advantages of the Curriculum Hannover Online from the perspective of patients, therapists, service providers and health care providers? Both studies will be conducted as two-arm randomised controlled trials. Individual rehabilitation patients will be randomised to the respective study arms. The system is based on a randomisation list (permuted blocks of variable length) with the help of the "Randlist" software at the sites. The order of the completed questionnaires determines the position in the list.
All data of the participants will be treated in accordance with the data security regulations (DSGVO), good scientific practice and the ethical requirements. Furthermore, all patients are informed about the project, ethics and data protection in a generally understandable way by a cover letter from their clinic before the treatment. All project staff are obliged to comply with the ethics guidelines and to maintain confidentiality. The pre- and post-data of the patients are combined by means of a personal code, which does not allow any conclusion about the participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention group 1 | Active comparator | Behavioral: Curriculum Hannoverwebbased aftercare |
| Control group | No intervention | –care as usual |
| Intervention group 2 | Active comparator | Behavioral: Curriculum Hannoverwebbased aftercare |
| face-to-face aftercare | Active comparator | Behavioral: Curriculum Hannoverface-to-face aftercare |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients after psychosomatic rehabilitation
- indication for outpatient psychosomatic aftercare are included in both studies.
- access to a standard PC and broadband internet connection is required (DSL or LTE).
Key exclusion criteria (5 listed)
- Persons who are
- are discharged with a capacity of less than three hours per day on the general labour market,
- receive or have applied for a pension of at least two-thirds of the full pension,
- receive a benefit that is regularly paid until the start of an old-age pension.
- suffering from acute addiction disorder / acute psychosis
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 |
|---|---|---|
| Curriculum HannoverThe methodology uses a natural variation design within the Dr. Becker Clinical Group. The interventions consist of a face-to-face or a digital psychosomatic aftercare basing upon the concept of the Curriculum Hanover. A control group is included that does not receive these two interventions (but receives a similar rehabilitation treatment to the intervention groups). | Behavioural | Intervention group 1, Intervention group 2, face-to-face aftercare |
Primary outcome
change of psychic and somatoform complaints
Time frame: up to 18 months
according to the HEALTH-49 (Rabung et al., 2009)
11 secondary outcomes
change of depressiveness
Time frame: up to 18 months
change of phobic anxiety
Time frame: up to 18 months
change of somatoform complaints
Time frame: up to 18 months
change of mental well-being
Time frame: up to 18 months
change of interactional difficulties
Time frame: up to 18 months
change of self-efficacy
Time frame: up to 18 months
change of activity and participation
Time frame: up to 18 months
change of social support
Time frame: up to 18 months
change of social stress
Time frame: up to 18 months
change of employment prognosis
Time frame: up to 18 months
change of workability
Time frame: up to 18 months
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 9 May 2022.
- Background: PubMed 25273302Andersson G, Cuijpers P, Carlbring P, Riper H, Hedman E. Guided Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: a systematic review and meta-analysis. World Psychiatry. 2014 Oct;13(3):288-95. doi: 10.1002/wps.20151.
- Background: PubMed 24844847Arnberg FK, Linton SJ, Hultcrantz M, Heintz E, Jonsson U. Internet-delivered psychological treatments for mood and anxiety disorders: a systematic review of their efficacy, safety, and cost-effectiveness. PLoS One. 2014 May 20;9(5):e98118. doi: 10.1371/journal.pone.0098118. eCollection 2014.
- Background: PubMed 22585048Cheng SK, Dizon J. Computerised cognitive behavioural therapy for insomnia: a systematic review and meta-analysis. Psychother Psychosom. 2012;81(4):206-16. doi: 10.1159/000335379. Epub 2012 May 11.
- Background: PubMed 20579332Cuijpers P, van Straten A, Warmerdam L, van Rooy MJ. Recruiting participants for interventions to prevent the onset of depressive disorders: possible ways to increase participation rates. BMC Health Serv Res. 2010 Jun 25;10:181. doi: 10.1186/1472-6963-10-181.
- Background: PubMed 20183688Cuijpers P, Marks IM, van Straten A, Cavanagh K, Gega L, Andersson G. Computer-aided psychotherapy for anxiety disorders: a meta-analytic review. Cogn Behav Ther. 2009;38(2):66-82. doi: 10.1080/16506070802694776.
- Background: PubMed 25121986Ebert DD, Lehr D, Boss L, Riper H, Cuijpers P, Andersson G, Thiart H, Heber E, Berking M. Efficacy of an internet-based problem-solving training for teachers: results of a randomized controlled trial. Scand J Work Environ Health. 2014 Nov;40(6):582-96. doi: 10.5271/sjweh.3449. Epub 2014 Aug 13.
- Background: PubMed 23736751Ebert D, Tarnowski T, Gollwitzer M, Sieland B, Berking M. A transdiagnostic internet-based maintenance treatment enhances the stability of outcome after inpatient cognitive behavioral therapy: a randomized controlled trial. Psychother Psychosom. 2013;82(4):246-56. doi: 10.1159/000345967. Epub 2013 Jun 1.
- Background: PubMed 22681915Haug T, Nordgreen T, Ost LG, Havik OE. Self-help treatment of anxiety disorders: a meta-analysis and meta-regression of effects and potential moderators. Clin Psychol Rev. 2012 Jul;32(5):425-45. doi: 10.1016/j.cpr.2012.04.002. Epub 2012 Apr 21.
- Background: PubMed 23761204Lin J, Ebert DD, Lehr D, Berking M, Baumeister H. [Internet based cognitive behavioral interventions: state of the art and implementation possibilities in rehabilitation]. Rehabilitation (Stuttg). 2013 Jun;52(3):155-63. doi: 10.1055/s-0033-1343491. Epub 2013 Jun 12. German.
- Background: PubMed 20332511Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. No abstract available.
- Background: PubMed 22352291Wolever RQ, Bobinet KJ, McCabe K, Mackenzie ER, Fekete E, Kusnick CA, Baime M. Effective and viable mind-body stress reduction in the workplace: a randomized controlled trial. J Occup Health Psychol. 2012 Apr;17(2):246-258. doi: 10.1037/a0027278. Epub 2012 Feb 20.
- Background: PubMed 22466510Richards D, Richardson T. Computer-based psychological treatments for depression: a systematic review and meta-analysis. Clin Psychol Rev. 2012 Jun;32(4):329-42. doi: 10.1016/j.cpr.2012.02.004. Epub 2012 Feb 28.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be published. Other researchers are welcome to get in contact with the PI to get access to anonymous data.
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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.
Alina Dahmen, MD study director
Dr. Becker Hospital Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curriculum Hannover in people with Psychosomatic Disorder and Mental Disorder, run by Dr. Becker Hospital Group 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 3 inclusion and 5 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 9 May 2022. 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.
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?
change of psychic and somatoform complaints (time frame: up to 18 months). 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 NCT04989842, which also lists 13 linked publications.
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 9 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.