The aim of the study is to investigate the mechanisms behind and influence of the PTSS assistance dog on military veterans with PTSD.
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cortisol level in saliva
Cortisol level in hair
PTSS questionnaire score
Quality of life questionnaire
Sleep quality questionnaire
Man dog attachment questionnaire
Heartbeat
Blood pressure
3D Activity
GPS activity
Secondary outcome
N.A.
Background summary
For some time there has been evidence availible that underlines the positive
influence of assistance dogs for military veterans with PTSD on the control and
reduction of PTSD symptoms. This evidence is composed of a combination of
self-reflection by veterans, subjective research into the well-being of people,
and case-reports based on observations. As a result, this evidence is only
based on subjective observation of the relationship between veterans and PTSS
assistance dogs, which makes it weak and tending towards face validity.
The lack of evidence about the influence of PTSS assistance dogs on the control
and reduction of PTSD symptoms means that at present no sensible statements can
be made about the exact manner in which the above-mentioned experiences and
observations may have come about. For example, it is unclear whether the
specific selection and training of individual PTSS assistance dogs contributes
to their perceived effectiveness. Research into the interaction between humans
and pets, in particular dogs, has already shown that positive interaction
between the two can bring about an experience of positive emotions. This effect
is undoubtedly also present between military veterans and PTSS assistance dogs,
which makes it doubtful to what extent specialized training has contributed to
observed results. In addition, due to the circulation of numerous success
stories nowadays, it can not be excluded that veterans with PTSD who come into
the possession of a PTSS service dog, automatically assess their own well-being
better / higher than before due to placebo effect. The assesment of improved
welfare an therefore not directly be attributed to the dog, let alone his
specialized training.
Because of all the above, it is currently very uncertain how the PTSS
assistance dog affects those who are supported by the dog and to what extent
the improvement in veterans can actually be attributed to the dog. It is
therefore important that thorough and objective research is conducted into the
efficacy, employability and general influence of assistant dogs for military
veterans with PTSD, so that insights based on empirical evidence can be
generated, which can help develop this form of therapy support. .
Study objective
The aim of the study is to investigate the mechanisms behind and influence of
the PTSS assistance dog on military veterans with PTSD.
Study design
This study consists of several measurement moments. The number of measurement
moments differs per group of participants (between 1 and 6 moments). In the
case of multiple measurement moments, the minimum interim period is 2 months.
The maximum time between the 1st and 6th measuring moments is 2 years.
A single measurement moment consists of nine days. On the 1st and 9th day,
participants are visited by the researchers. The 1st visit takes about 66
minutes, the second 30 minutes. In the 7 days between visits, participants are
asked to take different samples themselves and to keep records. This takes 24
minutes a day the first two days and less than 5 minutes on the remaining days.
The total time load is estimated at 199 minutes per measurement moment divided
over 9 days.
For each measurement moment participants will be asked to participate in
multiple measurements: First of all, participants will be asked to fill in six
questionnaires per measurement moment. These will be spread over the 9 days
that take a measurement moment. Participants are also asked to participate in 3
saliva measurements around the first 2 of the aforementioned questionnaires.
These will be used for the determination of oxytocin levels in both the
participant and his (assistance) dog in response to the first 2 questionnaires.
The first measurement takes place just before the 1st questionnaire, the 2nd
immediately after completion of the 2nd questionnaire, and the 3rd 30 minutes
after completion. Samples are taken with a swap which must be kept in the mouth
for 1 minute to passively absorb saliva. Because of potential sample
contamination, participants are asked to eat or drink nothing but flat water
from 30 minutes before and during these measurements.
Furthermore, participants will be asked to record their own GPS data for 7-day,
using a mobile app.
Participants are asked to take 5 saliva samples per day of their own and their
assistance dogs (if applicable) for 2 days. This gives a total of 10 samples
for humans and 10 for dogs. Samples are taken with a swap which must be kept in
the mouth for 1 minute to passively absorb saliva.Because of potential sample
contamination, participants are asked to eat or drink nothing but flat water
from 30 minutes before and during these measurements.
Some participants will be asked to wear a physiological measuring instrument
for the period of 48 hours. This instrument has about the size of a watch and
registers heart rate, blood pressure, and activity while being worn.
At the end of the study, a (small) hair sample from each subject is asked for
cortisol analysis.
Data as described above will be encripted by assigning a code to each subject.
The key for this code is known only to the researchers. Data from 1 subject
will remain linked under this code.
Study burden and risks
Possible positive diagnosis for PTSD by completing the PTSS questionnaire while
this diagnosis was not yet known to the subject. The researchers maintain the
option that unexpected diagnoses of PTSD are not likely to occur during the
study.
Yalelaan 2
Utrecht 3584 CM
NL
Yalelaan 2
Utrecht 3584 CM
NL
Listed location countries
Age
Inclusion criteria
Shared inclusion criteria between all participating subjects are, all subjects must be military or ex-military personnel, at least 18 years of age or older, of mixed sex, and capable to give written consent for participation. More specific inclusion criteria differ between subject groups, and concern specific lifestyle details like the current presence of a PTSD service dog for an individual.
Exclusion criteria
Exclusion criteria for all subjects are, non-military personnel, younger than 18 years of age, not mentally capable of giving written consent, and aggressive behaviour.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL64117.041.18 |