Psychological DiseaseNCT04475055
Reliability and Validity of the DIPS (Structured Interview) in a Community Sample
An observational study of Psychological Disease, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
The DIPS (Diagnostisches Interview bei psychischen Störungen) is a structured interview to assess a variety of the most frequent psychological disorders. Its reliability and validity has been studied in clinical samples. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Disease
- What is being tested?
- Diagnostisches Interview bei psychischen Störungen (DIPS)
- How many people
- 143 participants
- Where
- 1 siteGermany
- Study dates
- 5 Jun 2020to 10 May 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All adults who are willing to complete the structured interview and the questionnaires of the online-survey are allowed to take part in the study.
Who may be able to join
- sufficient knowledge of the German language
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability and Validity of the DIPS (Diagnostisches Interview Bei Psychischen Störungen; a Structured Interview to Assess Psychological Disorders) in a Community Sample
The DIPS (Diagnostisches Interview bei psychischen Störungen) is a structured interview to assess a variety of the most frequent psychological disorders. Its reliability and validity has been studied in clinical samples. Since structured interviews are also used in non-clinical samples like epidemiological research the investigators would like to conduct a study in a community sample to test the interview's reliability, validity and acceptance.
Read the detailed description
The DIPS (Diagnostisches Interview bei psychischen Störungen) is a structured interview to assess a variety of the most frequent psychological disorders. Its reliability and validity has been demonstrated in clinical samples. Also, studies have tested patients' and therapist's acceptance of the interview. Since structured interviews are also used in non-clinical samples like epidemiological research the investigators would like to conduct a study in a community sample to test the interview's reliability, validity and acceptance in this population (study aim 1). The investigators also plan to compare positive mental health and affective styles of the subsample of participants with no current or lifetime mental health illness to patients from the local outpatient treatment center at the Ruhr-University Bochum, who all reported at least one current mental illness (study aim 2). If the researchers obtain enough participants with no current mental health problem, but a history of at least one mental health illness, they will be included in the analysis for study aim 2 as well.
Since the data collection takes place during the Corona pandemic, participants will also be asked to give information about how they are affected, about their living situation and their media use over the course of half a year to describe the sample and to determine the impact of these factors on the incidence and course of mental illness (study aim 3).
- Conditions
- Psychological Disease
- Being tested
- Diagnostisches Interview bei psychischen Störungen (DIPS)
- Keywords
- clinical interview, community sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostisches Interview bei psychischen Störungen (DIPS)Diagnostic test
The DIPS is a structured interview which assesses the most frequent psychological disorders. It can be delivered by trained clinicians and takes between 50-120 minutes. Its acceptance with patients is very good.
| Study group | Role | What they receive |
|---|---|---|
| Community sample | Participants will take part in the DIPS-interview and in an online survey. Receives: Diagnostic Test: Diagnostisches Interview bei psychischen Störungen (DIPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Affective Styles Questionnaire (ASQ, Hofmann & Kashdan, 2010)
A 20-item scale measuring the three affective styles concealing, adjusting, and tolerating, on a 5-point Likert scale ranging from (1) = "not true of me at all" to (5) = "extremely true of me". Higher scores indicate a stronger tendency towards concealing, adjusting and tolerating respectively.
Measured: Baseline
Affective Styles Questionnaire (ASQ, Hofmann & Kashdan, 2010)
A 20-item scale measuring the three affective styles concealing, adjusting, and tolerating, on a 5-point Likert scale ranging from (1) = "not true of me at all" to (5) = "extremely true of me". Higher scores indicate a stronger tendency towards concealing, adjusting and tolerating respectively.
Measured: after 4 months
Affective Styles Questionnaire (ASQ, Hofmann & Kashdan, 2010)
A 20-item scale measuring the three affective styles concealing, adjusting, and tolerating, on a 5-point Likert scale ranging from (1) = "not true of me at all" to (5) = "extremely true of me".Higher scores indicate a stronger tendency towards concealing, adjusting and tolerating respectively.
Measured: after 6 months
Depression Anxiety Stress Scale -21 (DASS-21; Nilges et al., 2015)
The DASS-21 is a 21-item scale that measures the negative emotional states of depression, anxiety, and stress on a 4- point severity/ frequency scale with higher scores indicating more severe depression, stress, and anxiety respectively.
Measured: baseline
Depression Anxiety Stress Scale -21 (DASS-21; Nilges et al., 2015)
The DASS-21 is a 21-item scale that measures the negative emotional states of depression, anxiety, and stress on a 4- point severity/ frequency scale with higher scores indicating more severe depression, stress, and anxiety respectively.
Measured: after 1 month
Depression Anxiety Stress Scale -21 (DASS-21; Nilges et al., 2015)
The DASS-21 is a 21-item scale that measures the negative emotional states of depression, anxiety, and stress on a 4- point severity/ frequency scale with higher scores indicating more severe depression, stress, and anxiety respectively.
Measured: after 2 months
Depression Anxiety Stress Scale -21 (DASS-21; Nilges et al., 2015)
The DASS-21 is a 21-item scale that measures the negative emotional states of depression, anxiety, and stress on a 4- point severity/ frequency scale with higher scores indicating more severe depression, stress, and anxiety respectively.
Measured: after 3 months
Depression Anxiety Stress Scale -21 (DASS-21; Nilges et al., 2015)
The DASS-21 is a 21-item scale that measures the negative emotional states of depression, anxiety, and stress on a 4- point severity/ frequency scale with higher scores indicating more severe depression, stress, and anxiety respectively.
Measured: after 4 months
Depression Anxiety Stress Scale -21 (DASS-21; Nilges et al., 2015)
The DASS-21 is a 21-item scale that measures the negative emotional states of depression, anxiety, and stress on a 4- point severity/ frequency scale with higher scores indicating more severe depression, stress, and anxiety respectively.
Measured: after 5 months
Depression Anxiety Stress Scale -21 (DASS-21; Nilges et al., 2015)
The DASS-21 is a 21-item scale that measures the negative emotional states of depression, anxiety, and stress on a 4- point severity/ frequency scale with higher scores indicating more severe depression, stress, and anxiety respectively.
Measured: after 6 months
Positive Mental Health Scale (PMH; Lukat et al., 2016)
A brief 9-item scale that assesses positive mental health on a 4-point likert scale. Higher scores indicating positive mental heath.
Measured: baseline
Positive Mental Health Scale (PMH; Lukat et al., 2016)
A brief 9-item scale that assesses positive mental health on a 4-point likert scale. Higher scores indicating positive mental heath.
Measured: after 4 months
Positive Mental Health Scale (PMH; Lukat et al., 2016)
A brief 9-item scale that assesses positive mental health on a 4-point likert scale. Higher scores indicating positive mental heath.
Measured: after 6 months
Acceptance of the interview (Bruchmüller et al., 2009)
A 10-item scale that assesses the participants acceptance of the DIPS on a 5-point likert scale. Higher scores indicate higher acceptance.
Measured: after 4 months (after the interview)
Secondary outcomes (19)
Family Climate Scale (FCS)
The FCS is a multilevel, self-report, whole-family index of aspects of family culture and process for use in nonclinical settings with families where the children may be adults. The questionnaire consists of a 60- items (10- items per subscale) on a five-point Likert-type responseformat, each including at least four reverse-codeditems, to guard against response set. Higher Scores indicate better family functioning.
Measured: Baseline
Therapeutisch Relevante Belastungsliste (TRB; reasons for therapy)
A 29- Item scale assessing the reasons behind a participants wish to receive psychotherapy. Higher scores indicate a higher need for therapy.
Measured: after 4 months (after the interview)
The Fear Questionnaire - Der Angstfragebogen (FQ; Hank et al., 1990)
A 15- item questionnaire measuring the extent to which specific situations are avoided in order to measure the level of anxiety. Higher scores indicate more severe avoidance/ fear .
Measured: after 4 months (after the interview)
The Agoraphobia Cognitions Questionnaire (ACQ; Ehlers et al., 1993),
A 15- item questionnaire that assesses fear related cognitions. Higher scores indicate higher levels of fear related cognitions.
Measured: after 4 months (after the interview)
Mobility Inventory for Agoraphobia (MI; Chambless et al., 1985)
A 27-item inventory for the measurement of self-reported agoraphobic avoidance behavior and frequency of panic attacks with higher scores indicating more severe avoidance and a higher frequency of panic attacks.
Measured: after 4 months (after the interview)
Body Sensations Questionnaire (BSQ; Chambless et al., 1984),
A 17-item questionnaire to measure the extent of anxiety in psychosomatic or functional complaints and non-organic somatic symptoms. A 5-point scale is used to assess the extent to which the symptom in question is causing fear or worry with 5 indicating more severe worries/ sensations.
Measured: after 4 months (after the interview)
Beck-Depression-Inventory-II (BDI-II; Hautzinger et al., 2006)
A 21-question multiple-choice self-report inventory for measuring the severity of depression. Each answer is being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms
Measured: after 4 months (after the interview)
Fragebogen zu Gedanken und Gefühlen (FGG; questionnaire assessing thoughts and feelings; Renneberg et al., 2010)
A 14- item screening tool for borderline-specific thinking. A high value is synonymous with a high level of approval for the individual items of the FGG.
Measured: after 4 months (after the interview)
Suicidal Behaviors Questionnaire-Revised (SBQ; Osman et al., 2001)
The SBQ-R is designed to identify risk factors for suicide. Its based on four questions. A total score of 7 and higher in the general population and a total score of 8 and higher in patients with psychiatric disorders indicates significant risk of suicidal behavior.
Measured: after 4 months (after the interview)
Eating Disorder Examination Questionnaire (EDE-Q; Mond et al., 2006)
The 28- item questionnaire is designed to assess eating disorder psychopathology. The EDE-Q is scored using a 7-point, forced-choice rating scale (0-6) with scores of 4 or higher indicative of clinical range.
Measured: after 4 months (after the interview)
Exzessives Computerspielen und Computerspielabhängigkeit im Jugendalter (excessive video game playing and video game addiction in adolescence; KFN-CSAS-II; Rehbein et al., 2009))
A14- item questionnaire, that assesses online gaming behaviour. A total value is determined for all items with which the severity of the symptom burden can be assessed.
Measured: after 4 months (after the interview)
LAST - Lübecker Alkoholabhängigkeit- und -missbrauch-Screening-Test (screening for alcohol dependency and abuse; Rumpf et al., 2001)
The last is a short, sensitive screening test for the detection of alcohol addiction and abuse. It contains 7 items, to be answered with "yes" or "no". A sum of 2 or more points indicates alcohol abuse or alcohol addiction.
Measured: after 4 months (after the interview)
Penn State Worry Questionnaire (PWQ; Glöckner-Rist et al., 2014) Penn State Worry Questionnaire (PSWQ)
A 16-item questionnaire, that identifies excessive, unrealistic worries as the central cognitive syndrome of generalized anxiety disorder.Items are rated on a five-point scale: 1-Not at all typical of me to 5-Very typical of me. Possible range of scores is 16-80 with the algorithm of total scores: 16-39 low worry, 40-59 moderate worry, and 60-80 high worry.
Measured: after 4 months (after the interview)
State-Trait Anxiety Inventory (STAI; Spielberger et al., 1994).
Its an inventory based on a 4-point Likert scale and consists of 40 questions measuring state and trait anxiety. Higher scores indicate greater anxiety.
Measured: after 4 months (after the interview)
Whiteley-Index (WI; Hinz et al., 2003)
An instrument for measuring hypochondria. Hypochondrical worries and beliefs are assessed with 14 items with higher scores indicating more severe hypochondria.
Measured: after 4 months (after the interview)
Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989)
The PSQI measures sleep quality on a 10-item scale.Higher scores indicate worse sleep quality.
Measured: after 4 months (after the interview)
PTSD Checklist for DSM-5 (PCL-5; Belvins et al., 2015)
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. A provisional PTSD diagnosis can be made by treating each item rated as 2 = "Moderately" or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 B item (questions 1-5), 1 C item (questions 6-7), 2 D items (questions 8-14), 2 E items (questions 15-20).
Measured: after 4 months (after the interview)
Symptom Checklist-90-R (SCL-90-R; Hessel et al., 2001)
Nine scales (10 questions per scale) (somatization, compulsiveness, insecurity in social contact, depression, anxiety, aggressiveness / hostility, phobic anxiety, paranoid thinking, psychoticism) and three global parameters (GSI, PSDI, PST) assess the psychological stress in the past seven days. It is scored on a five-point Likert scale, indicating the rate of occurrence of the symptom during the time reference. Higher scores indicate more severe symptoms.
Measured: after 4 months (after the interview)
Balanced Inventory of desireable Responding (BIDR; Paulhus; 1991)
The questionnaire consists of two scales with 10 items each measuring two aspects of social desirability: self- deceptive enhancement and impression management. On a 7-point likert scale (from "1 = does not apply at all" to "7 = applies fully") it is assessed to what extent participants agree or disagree with the statements with higher scores representing social desirability.
Measured: after 4 months (after the interview)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start5 Jun 2020
- Primary completion10 May 2021
- Study completion10 May 2021
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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth von Brachel, Ruhr University of Bochum
- Investigators
- Silvia Schneider, Prof., Study director, Ruhr-University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475055
- Sponsor's protocol ID
- 2014-149
- Status last verified
- Apr 2024
- First submitted
- 14 Jul 2020
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the DIPS (Diagnostisches Interview Bei Psychischen Störungen; a Structured Interview to Assess Psychological Disorders) in a Community Sample
- ClinicalTrials.gov ID
- NCT04475055
- Acronym / sponsor ID
- 2014-149
- Conditions
- Psychological Disease
- Keywords
- clinical interview, community sample
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 10 May 2021 (actual)
- First posted
- 17 Jul 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 DIPS (Diagnostisches Interview bei psychischen Störungen) is a structured interview to assess a variety of the most frequent psychological disorders. Its reliability and validity has been studied in clinical samples. Since structured interviews are also used in non-clinical samples like epidemiological research the investigators would like to conduct a study in a community sample to test the interview's reliability, validity and acceptance.
Detailed description
The DIPS (Diagnostisches Interview bei psychischen Störungen) is a structured interview to assess a variety of the most frequent psychological disorders. Its reliability and validity has been demonstrated in clinical samples. Also, studies have tested patients' and therapist's acceptance of the interview. Since structured interviews are also used in non-clinical samples like epidemiological research the investigators would like to conduct a study in a community sample to test the interview's reliability, validity and acceptance in this population (study aim 1). The investigators also plan to compare positive mental health and affective styles of the subsample of participants with no current or lifetime mental health illness to patients from the local outpatient treatment center at the Ruhr-University Bochum, who all reported at least one current mental illness (study aim 2). If the researchers obtain enough participants with no current mental health problem, but a history of at least one mental health illness, they will be included in the analysis for study aim 2 as well.
Since the data collection takes place during the Corona pandemic, participants will also be asked to give information about how they are affected, about their living situation and their media use over the course of half a year to describe the sample and to determine the impact of these factors on the incidence and course of mental illness (study aim 3).
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community sample | – | Diagnostic Test: Diagnostisches Interview bei psychischen Störungen (DIPS)Participants will take part in the DIPS-interview and in an online survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adults who are willing to complete the structured interview and the questionnaires of the online-survey are allowed to take part in the study.
Key inclusion criteria (1 listed)
- sufficient knowledge of the German language
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 |
|---|---|---|
| Diagnostisches Interview bei psychischen Störungen (DIPS)The DIPS is a structured interview which assesses the most frequent psychological disorders. It can be delivered by trained clinicians and takes between 50-120 minutes. Its acceptance with patients is very good. | Diagnostic test | Community sample |
Primary outcome
Affective Styles Questionnaire (ASQ, Hofmann & Kashdan, 2010)
Time frame: Baseline
A 20-item scale measuring the three affective styles concealing, adjusting, and tolerating, on a 5-point Likert scale ranging from (1) = "not true of me at all" to (5) = "extremely true of me". Higher scores indicate a stronger tendency towards concealing, adjusting and tolerating respectively.
Affective Styles Questionnaire (ASQ, Hofmann & Kashdan, 2010)
Time frame: after 4 months
A 20-item scale measuring the three affective styles concealing, adjusting, and tolerating, on a 5-point Likert scale ranging from (1) = "not true of me at all" to (5) = "extremely true of me". Higher scores indicate a stronger tendency towards concealing, adjusting and tolerating respectively.
Affective Styles Questionnaire (ASQ, Hofmann & Kashdan, 2010)
Time frame: after 6 months
A 20-item scale measuring the three affective styles concealing, adjusting, and tolerating, on a 5-point Likert scale ranging from (1) = "not true of me at all" to (5) = "extremely true of me".Higher scores indicate a stronger tendency towards concealing, adjusting and tolerating respectively.
Depression Anxiety Stress Scale -21 (DASS-21; Nilges et al., 2015)
Time frame: baseline
The DASS-21 is a 21-item scale that measures the negative emotional states of depression, anxiety, and stress on a 4- point severity/ frequency scale with higher scores indicating more severe depression, stress, and anxiety respectively.
Depression Anxiety Stress Scale -21 (DASS-21; Nilges et al., 2015)
Time frame: after 1 month
The DASS-21 is a 21-item scale that measures the negative emotional states of depression, anxiety, and stress on a 4- point severity/ frequency scale with higher scores indicating more severe depression, stress, and anxiety respectively.
Depression Anxiety Stress Scale -21 (DASS-21; Nilges et al., 2015)
Time frame: after 2 months
The DASS-21 is a 21-item scale that measures the negative emotional states of depression, anxiety, and stress on a 4- point severity/ frequency scale with higher scores indicating more severe depression, stress, and anxiety respectively.
Depression Anxiety Stress Scale -21 (DASS-21; Nilges et al., 2015)
Time frame: after 3 months
The DASS-21 is a 21-item scale that measures the negative emotional states of depression, anxiety, and stress on a 4- point severity/ frequency scale with higher scores indicating more severe depression, stress, and anxiety respectively.
Depression Anxiety Stress Scale -21 (DASS-21; Nilges et al., 2015)
Time frame: after 4 months
The DASS-21 is a 21-item scale that measures the negative emotional states of depression, anxiety, and stress on a 4- point severity/ frequency scale with higher scores indicating more severe depression, stress, and anxiety respectively.
Depression Anxiety Stress Scale -21 (DASS-21; Nilges et al., 2015)
Time frame: after 5 months
The DASS-21 is a 21-item scale that measures the negative emotional states of depression, anxiety, and stress on a 4- point severity/ frequency scale with higher scores indicating more severe depression, stress, and anxiety respectively.
Depression Anxiety Stress Scale -21 (DASS-21; Nilges et al., 2015)
Time frame: after 6 months
The DASS-21 is a 21-item scale that measures the negative emotional states of depression, anxiety, and stress on a 4- point severity/ frequency scale with higher scores indicating more severe depression, stress, and anxiety respectively.
Positive Mental Health Scale (PMH; Lukat et al., 2016)
Time frame: baseline
A brief 9-item scale that assesses positive mental health on a 4-point likert scale. Higher scores indicating positive mental heath.
Positive Mental Health Scale (PMH; Lukat et al., 2016)
Time frame: after 4 months
A brief 9-item scale that assesses positive mental health on a 4-point likert scale. Higher scores indicating positive mental heath.
Positive Mental Health Scale (PMH; Lukat et al., 2016)
Time frame: after 6 months
A brief 9-item scale that assesses positive mental health on a 4-point likert scale. Higher scores indicating positive mental heath.
Acceptance of the interview (Bruchmüller et al., 2009)
Time frame: after 4 months (after the interview)
A 10-item scale that assesses the participants acceptance of the DIPS on a 5-point likert scale. Higher scores indicate higher acceptance.
19 secondary outcomes
Family Climate Scale (FCS)
Time frame: Baseline
Therapeutisch Relevante Belastungsliste (TRB; reasons for therapy)
Time frame: after 4 months (after the interview)
The Fear Questionnaire - Der Angstfragebogen (FQ; Hank et al., 1990)
Time frame: after 4 months (after the interview)
The Agoraphobia Cognitions Questionnaire (ACQ; Ehlers et al., 1993),
Time frame: after 4 months (after the interview)
Mobility Inventory for Agoraphobia (MI; Chambless et al., 1985)
Time frame: after 4 months (after the interview)
Body Sensations Questionnaire (BSQ; Chambless et al., 1984),
Time frame: after 4 months (after the interview)
Beck-Depression-Inventory-II (BDI-II; Hautzinger et al., 2006)
Time frame: after 4 months (after the interview)
Fragebogen zu Gedanken und Gefühlen (FGG; questionnaire assessing thoughts and feelings; Renneberg et al., 2010)
Time frame: after 4 months (after the interview)
Suicidal Behaviors Questionnaire-Revised (SBQ; Osman et al., 2001)
Time frame: after 4 months (after the interview)
Eating Disorder Examination Questionnaire (EDE-Q; Mond et al., 2006)
Time frame: after 4 months (after the interview)
Exzessives Computerspielen und Computerspielabhängigkeit im Jugendalter (excessive video game playing and video game addiction in adolescence; KFN-CSAS-II; Rehbein et al., 2009))
Time frame: after 4 months (after the interview)
LAST - Lübecker Alkoholabhängigkeit- und -missbrauch-Screening-Test (screening for alcohol dependency and abuse; Rumpf et al., 2001)
Time frame: after 4 months (after the interview)
Penn State Worry Questionnaire (PWQ; Glöckner-Rist et al., 2014) Penn State Worry Questionnaire (PSWQ)
Time frame: after 4 months (after the interview)
State-Trait Anxiety Inventory (STAI; Spielberger et al., 1994).
Time frame: after 4 months (after the interview)
Whiteley-Index (WI; Hinz et al., 2003)
Time frame: after 4 months (after the interview)
Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989)
Time frame: after 4 months (after the interview)
PTSD Checklist for DSM-5 (PCL-5; Belvins et al., 2015)
Time frame: after 4 months (after the interview)
Symptom Checklist-90-R (SCL-90-R; Hessel et al., 2001)
Time frame: after 4 months (after the interview)
Balanced Inventory of desireable Responding (BIDR; Paulhus; 1991)
Time frame: after 4 months (after the interview)
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 10 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Silvia Schneider, 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, 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 10 Apr 2024. 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?
Affective Styles Questionnaire (ASQ, Hofmann & Kashdan, 2010) (time frame: Baseline). The study lists 14 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 10 Apr 2024.