- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04450238
The Dual Factor Model of Mental Health in Inpatients
The Dual Factor Model of Mental Health: A Longitudinal Study in Inpatients
The Dual Factor Model of mental health (DFM; Greensporn & Saklofske, 2001) postulates that mental health consists of two at least partially unrelated factors, the experience or absence of psycho-pathological symptoms (i.e. depressive symptoms) and the experience or absence of positive mental health (i.e. life satisfaction, meaningfulness). Both factors contribute to an individual's well-being and mental health.The DFM has been used as a framework to describe and evaluate participants' mental health in different settings in cross-sectional and longitudinal designs mostly outside of clinical settings. Psychological Interventions, such as cognitive-behavioral therapy are widely studied concerning their reduction of psycho-pathological symptoms. However, little is known about the effect of psychological interventions on the second factor (positive mental health) of the DFM. This is especially important, because the latter has been shown to contribute significantly to subjective well-being and to reduce the risk of suicidal intentions and behavior.
Primary, the authors aim to investigate the DFM in an inpatient sample over the course of time (pre-treatment, post-treatment, 6 and 12 months after discharge). Secondly, they aim to investigate the relationship between positive mental health and suicidal ideation over the course of time.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants will be divided into four groups according to the DFM over the course of time:
- unhappy: high psychopathology and low positive mental health; depression and/or anxiety scores above published cut -offs and positive mental health scores under published cut offs.
- symptomatic but content: high psychopathology and high positive mental health; depression and/or anxiety scores above published cut -offs and normal to high positive mental health scores
- vulnerable: low psychopathology and low positive mental health; depression and/or anxiety scores under published cut -offs and positive mental health scores under published cut offs
- Complete mental health: low psychopathology and high positive mental health; depression and/or anxiety scores under published cut -offs normal to high positive mental health scores.
The authors will then depict the movements of patients through these groups graphically and use regression analyses to check for differences according to age, diagnosis and gender.
Towards the second aim they will use regression analyses to investigate the protective effect of positive mental health on suicidal ideation or behavior.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Bavaria
-
Oberstdorf, Bavaria, Germany, 87561
- Stillachhaus Privatklinik
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
-inpatients at the Stiilachaus Privatklinik
Exclusion Criteria:
-None
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study Group
All participants are inpatients at the clinic "Stillachhaus" in Germany.
They are receiving treatment for a variety of psychological disoders, mostly depressive disoders.
|
All participants are receiving inpatient treatment consisting of a variety of psychological interventions such as cognitive-behavioral therapy, third-wave interventions, psycho-education and in some cases medication.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression Anxiety Stress Scale-21 (DASS-21; Nilges et al., 2016)
Time Frame: In the first 3 days of treatment
|
Measures depression, anxiety and stress with 21 items.
Scores range from 0-63 with higher scores indicating more severe anxiety, depression and stress.
|
In the first 3 days of treatment
|
Depression Anxiety Stress Scale-21 (DASS-21; Nilges et al., 2016)
Time Frame: In the last three days of treatment
|
Measures depression, anxiety and stress with 21 items.
Scores range from 0-63 with higher scores indicating more severe anxiety, depression and stress.
|
In the last three days of treatment
|
Depression Anxiety Stress Scale-21 (DASS-21; Nilges et al., 2016)
Time Frame: 6 months after discharge
|
Measures depression, anxiety and stress with 21 items.
Scores range from 0-63 with higher scores indicating more severe anxiety, depression and stress.
|
6 months after discharge
|
Depression Anxiety Stress Scale-21 (DASS-21; Nilges et al., 2016)
Time Frame: 12 months after discharge
|
Measures depression, anxiety and stress with 21 items.
Scores range from 0-63 with higher scores indicating more severe anxiety, depression and stress.
|
12 months after discharge
|
Positive mental health scale (PMH; Lukat et al., 2016)
Time Frame: In the first 3 days of treatment
|
Measures positive psychological functioning with 9 items.
Scores range from 0-27 with higher scores indicating more positive mental health.
|
In the first 3 days of treatment
|
Positive mental health scale (PMH; Lukat et al., 2016)
Time Frame: In the last three days of treatment
|
Measures positive psychological functioning with 9 items.
Scores range from 0-27 with higher scores indicating more positive mental health
|
In the last three days of treatment
|
Positive mental health scale (PMH; Lukat et al., 2016)
Time Frame: 6 months discharge
|
Measures positive psychological functioning with 9 items.
Scores range from 0-27 with higher scores indicating more positive mental health
|
6 months discharge
|
Positive mental health scale (PMH; Lukat et al., 2016)
Time Frame: 12 months discharge
|
Measures positive psychological functioning with 9 items.
Scores range from 0-27 with higher scores indicating more positive mental health.
|
12 months discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Suicidal Behavior Questionnaire (SBQ; Osman et al., 2001) ).
Time Frame: In the first 3 days of treatment
|
Assesses past and current suicidal ideation and behavior.
Scores range from 3-18 with higher scores indicating a higher risk for suicidal behavior.
|
In the first 3 days of treatment
|
Suicidal Behavior Questionnaire (SBQ; Osman et al., 2001) ).
Time Frame: In the last three days of treatment
|
Assesses past and current suicidal ideation and behavior.
Scores range from 3-18 with higher scores indicating a higher risk for suicidal behavior.
|
In the last three days of treatment
|
Suicidal Behavior Questionnaire (SBQ; Osman et al., 2001) ).
Time Frame: 6 months after discharge
|
Assesses past and current suicidal ideation and behavior.
Scores range from 3-18 with higher scores indicating a higher risk for suicidal behavior.
|
6 months after discharge
|
Suicidal Behavior Questionnaire (SBQ; Osman et al., 2001) ).
Time Frame: 12 months after discharge
|
Assesses past and current suicidal ideation and behavior.
Scores range from 3-18 with higher scores indicating a higher risk for suicidal behavior.
|
12 months after discharge
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Juergen Margraf, Prof., Ruhr-University Bochum
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-387
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
Clinical Trials on Routine care inpatient treatment
-
First Affiliated Hospital Xi'an Jiaotong UniversityNot yet recruitingAcute Myocardial InfarctionChina
-
Medical University InnsbruckCompletedDepression | Affective Disorders, PsychoticAustria
-
The University of Texas Health Science Center,...CompletedChronic IllnessesUnited States
-
Institut Mutualiste MontsourisInstitut National de la Santé Et de la Recherche Médicale, France; Ministry... and other collaboratorsUnknown
-
Christian Grundtvig Refstrup RasmussenRecruitingOrthopedic Procedures | Ankle Fractures | Inpatient | Surgical ProceduresDenmark
-
Rabin Medical CenterUnknown
-
Norwegian University of Science and TechnologySt. Olavs Hospital; Norwegian Foundation for Health and RehabilitationCompletedAnorexia Nervosa | Bulimia Nervosa | Eating Disorder | Personality DisorderNorway
-
Universität Duisburg-EssenCompletedDiabetes Mellitus, Type 2 | Diabetic NeuropathyGermany
-
Vivantes Netzwerk für Gesundheit GmbHMedizinische Hochschule Brandenburg Theodor Fontane; Vivantes Klinikum am Urban and other collaboratorsActive, not recruitingPersonality Disorders | Anxiety Disorders | Addiction | Schizo Affective Disorder | Mental Disorder | Eating DisordersGermany
-
Göteborg UniversityCompletedGastrointestinal Diseases | Endocrine System DiseasesSweden