Psychological DiseaseNCT04450238
The Dual Factor Model of Mental Health in Inpatients
An observational study of Psychological Disease and Depression, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Disease, Depression
- What is being tested?
- Routine care inpatient treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,552 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jul 2017to 14 Nov 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients at Stillachhaus Privatklinik fill out the questionnaires prior and post treatment as part of their routine assessment. They are invited to fill out the same measures 6 and 12 months after discharge voluntarily to support the long-term evaluation of their treatment. They have all given written informed consent to use their data for publication.
Who may be able to join
- -inpatients at the Stiilachaus Privatklinik
Who cannot join
- -None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychological Disease, Depression
- Being tested
- Routine care inpatient treatment
- Keywords
- Dual Factor Model, Positive mental health, Suicidal ideation
- Medical subject headings
- Depression, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine care inpatient treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Routine care inpatient treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Anxiety Stress Scale-21 (DASS-21; Nilges et al., 2016)
Measures depression, anxiety and stress with 21 items. Scores range from 0-63 with higher scores indicating more severe anxiety, depression and stress.
Measured: In the first 3 days of treatment
Depression Anxiety Stress Scale-21 (DASS-21; Nilges et al., 2016)
Measures depression, anxiety and stress with 21 items. Scores range from 0-63 with higher scores indicating more severe anxiety, depression and stress.
Measured: In the last three days of treatment
Depression Anxiety Stress Scale-21 (DASS-21; Nilges et al., 2016)
Measures depression, anxiety and stress with 21 items. Scores range from 0-63 with higher scores indicating more severe anxiety, depression and stress.
Measured: 6 months after discharge
Depression Anxiety Stress Scale-21 (DASS-21; Nilges et al., 2016)
Measures depression, anxiety and stress with 21 items. Scores range from 0-63 with higher scores indicating more severe anxiety, depression and stress.
Measured: 12 months after discharge
Positive mental health scale (PMH; Lukat et al., 2016)
Measures positive psychological functioning with 9 items. Scores range from 0-27 with higher scores indicating more positive mental health.
Measured: In the first 3 days of treatment
Positive mental health scale (PMH; Lukat et al., 2016)
Measures positive psychological functioning with 9 items. Scores range from 0-27 with higher scores indicating more positive mental health
Measured: In the last three days of treatment
Positive mental health scale (PMH; Lukat et al., 2016)
Measures positive psychological functioning with 9 items. Scores range from 0-27 with higher scores indicating more positive mental health
Measured: 6 months discharge
Positive mental health scale (PMH; Lukat et al., 2016)
Measures positive psychological functioning with 9 items. Scores range from 0-27 with higher scores indicating more positive mental health.
Measured: 12 months discharge
Secondary outcomes (4)
Suicidal Behavior Questionnaire (SBQ; Osman et al., 2001) ).
Assesses past and current suicidal ideation and behavior. Scores range from 3-18 with higher scores indicating a higher risk for suicidal behavior.
Measured: In the first 3 days of treatment
Suicidal Behavior Questionnaire (SBQ; Osman et al., 2001) ).
Assesses past and current suicidal ideation and behavior. Scores range from 3-18 with higher scores indicating a higher risk for suicidal behavior.
Measured: In the last three days of treatment
Suicidal Behavior Questionnaire (SBQ; Osman et al., 2001) ).
Assesses past and current suicidal ideation and behavior. Scores range from 3-18 with higher scores indicating a higher risk for suicidal behavior.
Measured: 6 months after discharge
Suicidal Behavior Questionnaire (SBQ; Osman et al., 2001) ).
Assesses past and current suicidal ideation and behavior. Scores range from 3-18 with higher scores indicating a higher risk for suicidal behavior.
Measured: 12 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start18 Jul 2017
- Primary completion14 Nov 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,552 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Collaborators
- Stillachhaus Privatklinik
- Responsible party
- Principal investigator, Ruth von Brachel, Ruhr University of Bochum
- Investigators
- Juergen Margraf, Prof., Study director, Ruhr-University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450238
- Sponsor's protocol ID
- 2017-387
- Status last verified
- Jun 2023
- First submitted
- 10 Jun 2020
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since we do not have written consent to publish the data we will refrain from making it publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dual Factor Model of Mental Health: A Longitudinal Study in Inpatients
- ClinicalTrials.gov ID
- NCT04450238
- Acronym / sponsor ID
- 2017-387
- Conditions
- Psychological Disease, Depression
- Keywords
- Dual Factor Model, Positive mental health, Suicidal ideation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,552 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Collaborators
- Stillachhaus Privatklinik
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 29 Jun 2020 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Behavioral: Routine care inpatient treatmentAll participants are inpatients at the clinic "Stillachhaus" in Germany. They are receiving treatment for a variety of psychological disoders, mostly depressive disoders. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients at Stillachhaus Privatklinik fill out the questionnaires prior and post treatment as part of their routine assessment. They are invited to fill out the same measures 6 and 12 months after discharge voluntarily to support the long-term evaluation of their treatment. They have all given written informed consent to use their data for publication.
Key inclusion criteria (1 listed)
- -inpatients at the Stiilachaus Privatklinik
Key exclusion criteria (1 listed)
- -None
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 |
|---|---|---|
| Routine care inpatient treatmentAll 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. | Behavioural | Study Group |
Primary outcome
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.
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.
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.
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.
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.
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
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
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.
4 secondary outcomes
Suicidal Behavior Questionnaire (SBQ; Osman et al., 2001) ).
Time frame: In the first 3 days of treatment
Suicidal Behavior Questionnaire (SBQ; Osman et al., 2001) ).
Time frame: In the last three days of treatment
Suicidal Behavior Questionnaire (SBQ; Osman et al., 2001) ).
Time frame: 6 months after discharge
Suicidal Behavior Questionnaire (SBQ; Osman et al., 2001) ).
Time frame: 12 months after discharge
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 18 Jun 2023.
- Individual participant dataSharing planned: No. Since we do not have written consent to publish the data we will refrain from making it publicly available.
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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.
Juergen Margraf, Prof. study director
Ruhr-University Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Disease and Depression, run by Ruhr University of Bochum 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 1 inclusion and 1 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 18 Jun 2023. 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?
Depression Anxiety Stress Scale-21 (DASS-21; Nilges et al., 2016) (time frame: In the first 3 days of treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2023.