NCT04450238

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,552

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2017

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 29, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2022

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

5.3 years

First QC Date

June 10, 2020

Last Update Submit

June 16, 2023

Conditions

Keywords

Dual Factor ModelPositive mental healthSuicidal ideation

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (4)

  • Suicidal Behavior Questionnaire (SBQ; Osman et al., 2001) ).

    In the first 3 days of treatment

  • Suicidal Behavior Questionnaire (SBQ; Osman et al., 2001) ).

    In the last three days of treatment

  • Suicidal Behavior Questionnaire (SBQ; Osman et al., 2001) ).

    6 months after discharge

  • Suicidal Behavior Questionnaire (SBQ; Osman et al., 2001) ).

    12 months after discharge

Study Arms (1)

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.

Behavioral: Routine care inpatient treatment

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • inpatients at the Stiilachaus Privatklinik

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stillachhaus Privatklinik

Oberstdorf, Bavaria, 87561, Germany

Location

MeSH Terms

Conditions

DepressionSuicidal Ideation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSuicideSelf-Injurious Behavior

Study Officials

  • Juergen Margraf, Prof.

    Ruhr-University Bochum

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 29, 2020

Study Start

July 18, 2017

Primary Completion

November 14, 2022

Study Completion

November 14, 2022

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Since we do not have written consent to publish the data we will refrain from making it publicly available.

Locations