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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04450238
Other study ID # 2017-387
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 18, 2017
Est. completion date November 14, 2022

Study information

Verified date June 2023
Source Ruhr University of Bochum
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Description:

Participants will be divided into four groups according to the DFM over the course of time: 1. 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. 2. 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 3. 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 4. 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.


Recruitment information / eligibility

Status Completed
Enrollment 1552
Est. completion date November 14, 2022
Est. primary completion date November 14, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: -inpatients at the Stiilachaus Privatklinik Exclusion Criteria: -None

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Routine care inpatient treatment
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.

Locations

Country Name City State
Germany Stillachhaus Privatklinik Oberstdorf Bavaria

Sponsors (2)

Lead Sponsor Collaborator
Ruhr University of Bochum Stillachhaus Privatklinik

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. In the first 3 days of treatment
Primary 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. In the last three days of treatment
Primary 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. 6 months after discharge
Primary 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. 12 months after discharge
Primary 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. In the first 3 days of treatment
Primary 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 In the last three days of treatment
Primary 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 6 months discharge
Primary 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. 12 months discharge
Secondary 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. In the first 3 days of treatment
Secondary 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. In the last three days of treatment
Secondary 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. 6 months after discharge
Secondary 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. 12 months after discharge
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