Psychotic Disorders Clinical Trial
Official title:
Efficacy of an Online-Based Self-Help Intervention for Auditory Hallucinations in Persons With Psychotic Disorders (ECHION)
The proposed clinical trial aims to examine the efficacy of an online-based self-help intervention for auditory hallucinations in persons with psychotic disorders. The intervention is primarily based on Metacognitive Training (MKT) and Mindfulness-Based Group Therapy (MBGT). The investigators will utilize a mixed-method study design within a randomized controlled trial. The intervention group will be compared with a waitlist-control group (WL-TAU). Both study conditions are allowed to continue standard scheduled treatment. The aim is to analyze the efficacy of and the subjective satisfaction with the intervention, based on self-report assessments evaluated from baseline (T0) to post-intervention after 6 weeks (T1).
The investigators will identify eligible participants at various outpatient departments, suitable support groups, online platforms, and social media. An eligibility screening (in person or by telephone) to ensure the inclusion criteria and to introduce the study is held by the study assistant. All participants must sign an informed electronic consent after written and verbal study clarification. If persons are eligible for participation, they will be randomized according to a randomization plan by the electronic database RedCap. Due to the psychotherapeutic nature of the study, there will be no blinding. Participants in both study conditions will carry out self-reported measurements (online) at baseline (T0) and after the intervention phase of 6 weeks (T1). With an anticipated n = 25 of persons from the intervention group, there will be additionally conducted semi-structured interviews at T1 that aim to examine specific patterns of auditory hallucinations and satisfaction with the intervention. The final sample of the qualitative research part will be determined according to the principle of saturation (content-related). The data management plan includes standard procedures for data-handling such as using anonymized identification codes for patient data. Besides, the participants have the right to access their data, and the right to claim an annihilation. The data is being saved in an online database, only allowing researchers involved in the study to access the data. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
| Terminated |
NCT03230097 -
This Study Tests Whether BI 409306 Prevents Patients With a Specific Type of Mental Illness (Attenuated Psychosis Syndrome) From Becoming Worse. This Study Looks at How Well Patients Tolerate the Medicine and How Effective it is Over 1 Year
|
Phase 2 | |
| Completed |
NCT03497663 -
VIA Family - Family Based Early Intervention Versus Treatment as Usual
|
N/A | |
| Active, not recruiting |
NCT05726617 -
Avatar Intervention for the Treatment of Cannabis Use Disorder in Patients With Severe Mental Health Disorders
|
N/A | |
| Not yet recruiting |
NCT03807388 -
ReMindCare App for Patients From First Episode of Psychosis Unit.
|
N/A | |
| Recruiting |
NCT02874573 -
Tocilizumab in Schizophrenia
|
Phase 1 | |
| Terminated |
NCT02584114 -
Brain Effects of Memory Training in Early Psychosis
|
N/A | |
| Completed |
NCT02906553 -
The Role of Nitric Oxide in Cognition in Schizophrenia
|
N/A | |
| Withdrawn |
NCT02213887 -
Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications
|
Phase 4 | |
| Terminated |
NCT02841956 -
Reducing Duration of Untreated Psychosis Through Rapid Identification and Engagement
|
N/A | |
| Completed |
NCT01981356 -
Acceptance and Commitment Therapy for the Inpatient Treatment of Psychosis
|
Phase 0 | |
| Recruiting |
NCT02848469 -
Irish Omega-3 Study
|
Phase 2 | |
| Recruiting |
NCT02009969 -
Serial Comparisons of Abdominal and Neurological MRI Scans
|
N/A | |
| Completed |
NCT02648321 -
Motivational Intervention for Physical Activity in Psychosis
|
N/A | |
| Enrolling by invitation |
NCT00762866 -
Psychiatric Genotype/Phenotype Project Repository
|
||
| Completed |
NCT00484302 -
Specialized Addiction Treatment Versus Treatment as Usual for Young Patients With Cannabis Abuse and Psychosis
|
N/A | |
| Completed |
NCT00130923 -
Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder
|
Phase 4 | |
| Completed |
NCT00455234 -
Rapid Tranquillization Trial: TREC-India II
|
Phase 3 | |
| Completed |
NCT00844922 -
Safety of Org 34517 900 mg in Patients Who Received Org 34517 in a Previous Trial (Study 28133/P05842)
|
Phase 2 | |
| Completed |
NCT00130676 -
A United States Study of Corlux for Psychotic Symptoms in Psychotic Major Depression
|
Phase 3 |