Post Traumatic Stress DisorderNCT03821259
Post-traumatic Stress Disorder (PTSD) Symptoms in Later Life
An observational study of Post Traumatic Stress Disorder, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Older adults are becoming a growing proportion of people utilising mental health services. However, the needs of this population are poorly understood despite the evidence that mental health conditions are manifested differently in old age. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Psychological measures
- How many people
- 88 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Nov 2018to 17 May 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: An opportunistic clinical sample of older adults, aged 65 and over, in receipt of psychological treatment for PTSD, anxiety or depression in the Older People Psychological Therapies Service in NHS Tayside will be recruited.
Who may be able to join
- Aged 65 years and over
- In receipt of psychological treatment for PTSD, anxiety or depression
- Fluent English speaker
- Ability to give consent
Who cannot join
- Cognitive impairment (MoCA ≤20)
- Under investigation for or a confirmed diagnosis of dementia
- Currently experiencing an episode of a serious mental illness, e.g. psychosis
- Ongoing substance misuse
- Ongoing serious risk issues (i.e. risk of harm to self and others, suicidality)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Tayside Older People Psychological Therapies service
Dundee, DD2 3PT
About this study
Official title: Post-traumatic Stress Disorder (PTSD) Symptoms in Later Life: the Contribution of Cumulative Trauma Exposure, Emotion Regulation, Group Identifications, and Socioeconomic Deprivation
Older adults are becoming a growing proportion of people utilising mental health services. However, the needs of this population are poorly understood despite the evidence that mental health conditions are manifested differently in old age. One of those conditions is Post Traumatic Stress Disorder (PTSD) which has been associated with an increased risk of adverse outcomes in old age, including health problems, difficulties in daily functioning, less satisfaction with life and multiple psychiatric co-morbidities, such as depression and anxiety. Despite the serious consequences, PTSD symptoms in old age tend to be underreported or misperceived as a physical illness or part of an ageing process.
Traumatic life experiences do not necessarily lead to PTSD. Psychological resources, including emotional stability and social support, allow individuals to find appropriate coping strategies and maintain well-being in old age. Group identification, defined as a sense of belonging to a specific group, influences the response to social support and may be important in predicting distress in old age. On the other hand, socioeconomic deprivation is likely to increase this distress as exposure to traumatic events is more prevalent in disadvantaged populations.
Read more
The present study will investigate the impact of those factors on PTSD symptoms in later life. The researcher will recruit 85 older adults from the Older People Psychological Therapies Service, who are in receipt of psychological treatment for PTSD, anxiety or depression. Participants will be asked to provide basic demographic information, which will be used to describe the participant characteristics and to estimate the degree of socioeconomic deprivation. Participants will also complete five measures to screen for cognitive impairment and measure PTSD symptoms, lifetime trauma exposure, emotion regulation and group identification.
The findings will help improve the diagnostic process and development of psychological treatments for PTSD in older adults by expanding our knowledge of this condition in later life.
Read the detailed description
Aim of the study:
To investigate the importance and relative contribution of interpersonal and intra-individual factors, including lifetime trauma exposure, emotion regulation, social group belonging and socioeconomic deprivation in predicting PTSD symptoms in older adults.
Primary research questions:
- Will greater lifetime trauma exposure predict higher levels of PTSD symptoms in older adults?
- Will greater difficulties in emotion regulation predict higher levels of PTSD symptoms in older adults?
- Will a lower number of group identifications predict higher levels of PTSD symptoms in older adults?
- Will higher levels of socioeconomic deprivation predict higher levels of PTSD symptoms in older adults?
Secondary research questions:
- What is the relative contribution of lifetime trauma exposure in predicting levels of PTSD symptoms in older adults?
- What is the relative contribution of difficulties in emotion regulation in predicting levels of PTSD symptoms in older adults?
- What is the relative contribution of group identifications in predicting levels of PTSD symptoms in older adults?
- What is the relative contribution of socioeconomic deprivation in predicting levels of PTSD symptoms in older adults?
Design:
The study will employ a cross-sectional, within-groups design. An opportunistic clinical sample of older adults, aged 65 and over, in receipt of psychological treatment for PTSD, anxiety or depression in the Older People Psychological Therapies Service in NHS Tayside will be recruited. Participants will be asked to provide basic demographic information and to complete five measures, screening for cognitive impermanent and measuring PTSD symptoms, lifetime trauma exposure, emotion regulation and group identification. Correlation and multiple regression analyses will be used to answer the research hypotheses.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Psychological measures
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological measuresOther
Participants will be asked to provide basic demographic information and to complete five measures, screening for cognitive impermanent and measuring PTSD symptoms, lifetime trauma exposure, emotion regulation and group identification.
| Study group | Role | What they receive |
|---|---|---|
| Older adults with mental health history | Eligible participants, aged 65 and over, will be established in treatment for PTSD, anxiety or depression in the Older Adult Psychological Therapies service. Receives: Other: Psychological measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Trauma History Questionnaire (THQ; Green, 1996)
This questionnaire measures lifetime exposure to a range of potentially traumatic experiences in three broad areas of (1) crime-related events, (2) general trauma and disasters, as well as (3) unwanted sexual experiences and physical violence, and (4) other unspecified extraordinarily stressful event . Participants will be required to answer 24 items in a yes/no. Total scores range from 0 to 24. Scores for subscales are as following: (1) crime-related events: 0 - 4; (2) general trauma and disasters: 0 - 13; (3) unwanted sexual experiences and physical violence: 0 - 6; (4) other: 0 -1. Higher scores indicate more traumatic events. The THQ was developed to be applicable to various populations and has been widely used in research. In a recent review of studies employing this measure, the THQ demonstrated sound psychometric properties, including a good interrater reliability and construct validity.
Measured: through study completion, an average of 6 months
The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
This questionnaire measures six aspects of emotion regulation, including (1) acceptance of emotional responses, (2) engagement in goal-directed behaviours, (3) impulse control, (4) emotional awareness, (5) access to emotion regulation strategies and (6) emotional clarity. Participants will be required to answer 36 items by indicating the frequency of each item on a 5-point scale ranging from 1='almost never' to 5='almost always'. The total score ranges from 36 to 180. Subscales will be explored for the purpose of this study. The score ranges for each subscale are as following: (1) acceptance of emotional responses: 6 - 30, (2) engagement in goal-directed behaviours: 5 - 25, (3) impulse control: 6 - 30, (4) emotional awareness: 6 - 30, (5) access to emotion regulation strategies: 8 - 40 and (6) emotional clarity: 5 - 25. Higher scores indicate greater difficulties in emotion regulation. The DERS demonstrated a good internal consistency (α=.80-.89) and acceptable validity.
Measured: through study completion, an average of 6 months
The Civilian Version of the PTSD Checklist (PCL-C; Weathers, Litz, Huska & Keane, 1994)
This questionnaire measures PTSD symptoms in the civilian population. Participants will be required to answer 17 items by rating the intensity of their symptoms on a 5-point scale ranging from 1='not at all' to 5='extremely'. Total scores range from 17 to 85. Higher scores indicate greater symptom severity. The PCL-C demonstrated a high internal consistency (α=.87-.94), good test-retest reliability and positive correlations with other widely used PTSD scales. It has been reported that this measure is suitable for use with older adults with a recommended cut-off score of 37 to reliably diagnose PTSD in this population.
Measured: through study completion, an average of 6 months
The Group Identification Scale (GIS; Sani et al., 2012)
This questionnaire measures identification with three groups (i.e. family, community and a social group chosen by the participant from the list provided, e.g. a group of friends, a voluntary group or a sports group). Identification with each group is measured with 4 items which encompass a general sense of belonging and commonality with in-group members, e.g. "I have a sense of belonging to [my group]". Participants rate their answers on a 7-point scale from 1='strongly disagree' to 7='strongly agree'. Total scores for 4 items measuring identification with each group range from 4 to 28. The cut-off score for group identification is 20, hence individuals whose total score is ≥20 across 4 items will be considered as identifying with the given group. The total number of groups the participant can identify with ranges between 0 and 3 groups. This number will be used in the final analysis. The GIS demonstrated a good internal reliability (α=.85-.92) and construct validity.
Measured: through study completion, an average of 6 months
The Scottish Index of Multiple Deprivation (SIMD; Scottish Executive, 2016)
The SIMD measures socioeconomic deprivation according to postcode information and is the only readily available measure of socioeconomic deprivation which covers the whole population of Scotland. For the purpose of this study, we will report the postcode information based on their assigned quintile, which ranges from 1 (most deprived) to 5 (least deprived).
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start6 Nov 2018
- Primary completion17 May 2019
- Study completion17 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Tayside
- Responsible party
- Sponsor
- Investigators
- Klaudia Suchorab, MSc, Principal investigator, NHS Tayside/University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821259
- Sponsor's protocol ID
- CAHSS1802/04
- Status last verified
- Jun 2020
- First submitted
- 19 Dec 2018
- Last updated
- 13 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-traumatic Stress Disorder (PTSD) Symptoms in Later Life: the Contribution of Cumulative Trauma Exposure, Emotion Regulation, Group Identifications, and Socioeconomic Deprivation
- ClinicalTrials.gov ID
- NCT03821259
- Acronym / sponsor ID
- CAHSS1802/04
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Tayside
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 17 May 2019 (actual)
- Study completion
- 17 May 2019 (actual)
- First posted
- 29 Jan 2019 (actual)
- Results
- Posted 23 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Older adults are becoming a growing proportion of people utilising mental health services. However, the needs of this population are poorly understood despite the evidence that mental health conditions are manifested differently in old age. One of those conditions is Post Traumatic Stress Disorder (PTSD) which has been associated with an increased risk of adverse outcomes in old age, including health problems, difficulties in daily functioning, less satisfaction with life and multiple psychiatric co-morbidities, such as depression and anxiety. Despite the serious consequences, PTSD symptoms in old age tend to be underreported or misperceived as a physical illness or part of an ageing process.
Traumatic life experiences do not necessarily lead to PTSD. Psychological resources, including emotional stability and social support, allow individuals to find appropriate coping strategies and maintain well-being in old age. Group identification, defined as a sense of belonging to a specific group, influences the response to social support and may be important in predicting distress in old age. On the other hand, socioeconomic deprivation is likely to increase this distress as exposure to traumatic events is more prevalent in disadvantaged populations.
The present study will investigate the impact of those factors on PTSD symptoms in later life. The researcher will recruit 85 older adults from the Older People Psychological Therapies Service, who are in receipt of psychological treatment for PTSD, anxiety or depression. Participants will be asked to provide basic demographic information, which will be used to describe the participant characteristics and to estimate the degree of socioeconomic deprivation. Participants will also complete five measures to screen for cognitive impairment and measure PTSD symptoms, lifetime trauma exposure, emotion regulation and group identification.
The findings will help improve the diagnostic process and development of psychological treatments for PTSD in older adults by expanding our knowledge of this condition in later life.
Detailed description
Aim of the study:
To investigate the importance and relative contribution of interpersonal and intra-individual factors, including lifetime trauma exposure, emotion regulation, social group belonging and socioeconomic deprivation in predicting PTSD symptoms in older adults.
Primary research questions:
- Will greater lifetime trauma exposure predict higher levels of PTSD symptoms in older adults?
- Will greater difficulties in emotion regulation predict higher levels of PTSD symptoms in older adults?
- Will a lower number of group identifications predict higher levels of PTSD symptoms in older adults?
- Will higher levels of socioeconomic deprivation predict higher levels of PTSD symptoms in older adults?
Secondary research questions:
- What is the relative contribution of lifetime trauma exposure in predicting levels of PTSD symptoms in older adults?
- What is the relative contribution of difficulties in emotion regulation in predicting levels of PTSD symptoms in older adults?
- What is the relative contribution of group identifications in predicting levels of PTSD symptoms in older adults?
- What is the relative contribution of socioeconomic deprivation in predicting levels of PTSD symptoms in older adults?
Design:
The study will employ a cross-sectional, within-groups design. An opportunistic clinical sample of older adults, aged 65 and over, in receipt of psychological treatment for PTSD, anxiety or depression in the Older People Psychological Therapies Service in NHS Tayside will be recruited. Participants will be asked to provide basic demographic information and to complete five measures, screening for cognitive impermanent and measuring PTSD symptoms, lifetime trauma exposure, emotion regulation and group identification. Correlation and multiple regression analyses will be used to answer the research hypotheses.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older adults with mental health history | – | Other: Psychological measuresEligible participants, aged 65 and over, will be established in treatment for PTSD, anxiety or depression in the Older Adult Psychological Therapies service. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- An opportunistic clinical sample of older adults, aged 65 and over, in receipt of psychological treatment for PTSD, anxiety or depression in the Older People Psychological Therapies Service in NHS Tayside will be recruited.
Key inclusion criteria (4 listed)
- Aged 65 years and over
- In receipt of psychological treatment for PTSD, anxiety or depression
- Fluent English speaker
- Ability to give consent
Key exclusion criteria (5 listed)
- Cognitive impairment (MoCA ≤20)
- Under investigation for or a confirmed diagnosis of dementia
- Currently experiencing an episode of a serious mental illness, e.g. psychosis
- Ongoing substance misuse
- Ongoing serious risk issues (i.e. risk of harm to self and others, suicidality)
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 |
|---|---|---|
| Psychological measuresParticipants will be asked to provide basic demographic information and to complete five measures, screening for cognitive impermanent and measuring PTSD symptoms, lifetime trauma exposure, emotion regulation and group identification. | Other | Older adults with mental health history |
Primary outcome
The Trauma History Questionnaire (THQ; Green, 1996)
Time frame: through study completion, an average of 6 months
This questionnaire measures lifetime exposure to a range of potentially traumatic experiences in three broad areas of (1) crime-related events, (2) general trauma and disasters, as well as (3) unwanted sexual experiences and physical violence, and (4) other unspecified extraordinarily stressful event . Participants will be required to answer 24 items in a yes/no. Total scores range from 0 to 24. Scores for subscales are as following: (1) crime-related events: 0 - 4; (2) general trauma and disasters: 0 - 13; (3) unwanted sexual experiences and physical violence: 0 - 6; (4) other: 0 -1. Higher scores indicate more traumatic events. The THQ was developed to be applicable to various populations and has been widely used in research. In a recent review of studies employing this measure, the THQ demonstrated sound psychometric properties, including a good interrater reliability and construct validity.
The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
Time frame: through study completion, an average of 6 months
This questionnaire measures six aspects of emotion regulation, including (1) acceptance of emotional responses, (2) engagement in goal-directed behaviours, (3) impulse control, (4) emotional awareness, (5) access to emotion regulation strategies and (6) emotional clarity. Participants will be required to answer 36 items by indicating the frequency of each item on a 5-point scale ranging from 1='almost never' to 5='almost always'. The total score ranges from 36 to 180. Subscales will be explored for the purpose of this study. The score ranges for each subscale are as following: (1) acceptance of emotional responses: 6 - 30, (2) engagement in goal-directed behaviours: 5 - 25, (3) impulse control: 6 - 30, (4) emotional awareness: 6 - 30, (5) access to emotion regulation strategies: 8 - 40 and (6) emotional clarity: 5 - 25. Higher scores indicate greater difficulties in emotion regulation. The DERS demonstrated a good internal consistency (α=.80-.89) and acceptable validity.
The Civilian Version of the PTSD Checklist (PCL-C; Weathers, Litz, Huska & Keane, 1994)
Time frame: through study completion, an average of 6 months
This questionnaire measures PTSD symptoms in the civilian population. Participants will be required to answer 17 items by rating the intensity of their symptoms on a 5-point scale ranging from 1='not at all' to 5='extremely'. Total scores range from 17 to 85. Higher scores indicate greater symptom severity. The PCL-C demonstrated a high internal consistency (α=.87-.94), good test-retest reliability and positive correlations with other widely used PTSD scales. It has been reported that this measure is suitable for use with older adults with a recommended cut-off score of 37 to reliably diagnose PTSD in this population.
The Group Identification Scale (GIS; Sani et al., 2012)
Time frame: through study completion, an average of 6 months
This questionnaire measures identification with three groups (i.e. family, community and a social group chosen by the participant from the list provided, e.g. a group of friends, a voluntary group or a sports group). Identification with each group is measured with 4 items which encompass a general sense of belonging and commonality with in-group members, e.g. "I have a sense of belonging to [my group]". Participants rate their answers on a 7-point scale from 1='strongly disagree' to 7='strongly agree'. Total scores for 4 items measuring identification with each group range from 4 to 28. The cut-off score for group identification is 20, hence individuals whose total score is ≥20 across 4 items will be considered as identifying with the given group. The total number of groups the participant can identify with ranges between 0 and 3 groups. This number will be used in the final analysis. The GIS demonstrated a good internal reliability (α=.85-.92) and construct validity.
The Scottish Index of Multiple Deprivation (SIMD; Scottish Executive, 2016)
Time frame: through study completion, an average of 6 months
The SIMD measures socioeconomic deprivation according to postcode information and is the only readily available measure of socioeconomic deprivation which covers the whole population of Scotland. For the purpose of this study, we will report the postcode information based on their assigned quintile, which ranges from 1 (most deprived) to 5 (least deprived).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Klaudia Suchorab, MSc principal investigator
NHS Tayside/University of Edinburgh
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 Post Traumatic Stress Disorder, run by University of Edinburgh at 1 site in United Kingdom.
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 4 inclusion and 5 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 13 Jul 2020. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 23 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Trauma History Questionnaire (THQ; Green, 1996) (time frame: through study completion, an average of 6 months). The study lists 5 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 13 Jul 2020.