The primary objective is to investigate the differences in mentalizing abilities between outpatients with chronic pain and a control group, consisting of outpatients with painful acute injuries or painful somatically explained conditions. The…
ID
Source
Brief title
Condition
- Bone and joint injuries
- Muscle disorders
- Somatic symptom and related disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the mentalizing ability of the participants.
Mentalizing is the ability to understand the self and others in terms of
intentional mental states (e.g. feelings, wishes, desires, and values; Luyten &
Fonagy, 2014). Mentalization includes both emotional self-awareness as the
awareness for emotional signals in others. It has a cognitive component, the
Theory of Mind (ToM); being able to process, reflect on and express one's own
and others' intentions and emotional signals. Next, mentalization consists of
an emotional component; e.g. being able to experience empathy. The mentalizing
ability will be measured using the FHAT, the LEAS-SF and the RFQ.
The Frith-Happe-Animations task (FHAT; Abell, Happe, & Frith, 2000)
The FHAT is a performance-based task measuring theory of mind (ToM). It
comprises animated video-clips of 34 to 45 seconds. In these clips two
triangles exhibit movement patterns of living beings. Individuals with
well-functioning ToM will identify these objects as intentional. Therefore, the
FHAT shows a person's ability to recognize ToM in interpersonal situations,
while excluding most of the potentially confounding factors present in social
settings (Abell et al., 2000; Zunhammer et al., 2015). The FHAT has a
ToM-condition and a Goal-Directed(GD)-condition. The ToM-condition comprises of
four video-clips, in which two triangles display interaction suggesting
behavior described as ''Surprising'', ''Coaxing'', ''Mocking'', and
''Seducing''. These clips require ToM for correct interpretation. As a control,
the GD-condition is included, in which the triangles display behaviors which do
not require higher order mentalizing abilities to interpret correctly. These
behaviors are ''Fighting'', ''Following'', ''Chasing'', and ''Dancing''.
Participants are asked to describe what they have seen after each video-clip.
The responses will be scored on an Intentionality and an Appropriateness scale.
The 5-point Intentionality scale shows to what extent deliberate actions and
intentions are ascribed to the triangles. The 3-point Appropriateness scale
reflects how close the given response matches the content of the video, as
intended by the designers. A score of 3 is given for the correct interpretation
and a score of 0 is given for no answer or ''I don't know'' (Castelli, Happe,
Frith, & Frith, 2000).
The Levels of Emotional Awareness Scale - Short Form (LEAS-SF; Lane, Quinlan,
Schwartz, Walker, & Zeitlin, 1990)
The LEAS-SF is a performance-based task, proposed to measure the ability to
identify and describe emotions. It uses ten vignettes, each describing an
imaginary situation in which the participant interacts with a second person.
Participants are asked to give a verbal description of the emotions that the
situation may invoke in them and in the second person involved (Lane et al.,
1990; Zunhammer et al., 2015). The construct of emotional awareness is defined
as a type of cognitive processing which undergoes five levels of structural
transformation along a cognitive-developmental sequence of levels. These levels
are derived from an integration of developmental theories of Piaget and Werner.
The five levels of structural transformation are awareness of (1) bodily
sensations, (2) the body in action, (3) individual feelings, (4) blends of
feelings and (5) blends of blends of feelings. Answers of participants are
scored following these levels of emotional awareness (Lane, & Schwartz, 1987;
Subic-Wrana, Beutel, Garfield, & Lane, 2011; Zunhammer et al., 2015).
Reflective Functioning Questionnaire (RFQ; Fonagy et al., 2016)
The RFQ is a brief eight item questionnaire to assess mentalizing abilities.
Items are answered on a six-point Likert scale (1 = I do not agree at all to 6
= I very much agree). The RFQ has two subscales, Certainty (RFQ-C) and
Uncertainty (RFQ-U), each containing six items. Four items are used to
calculate scores on both subscales, while the other four items are unique to
each subscale. For a detailed description of scoring procedures see De
Meulemeester, Vansteelandt, Luyten, Lowyck, 2018 and Fonagy et al. 2016.
Research in French and Italian populations showed satisfactory reliability and
construct validity of the two subscales (Badoud et al., 2015; Morandotti et
al., 2018).
Secondary outcome
The secondary study parameters are childhood adversities, attachment style and
the quality of the patient-doctor relationship. Childhood adversities are
defined as maltreatment before the age of seventeen. This maltreatment can
consist of physical abuse, emotional abuse, sexual abuse, physical neglect, and
emotional neglect (Thombs, Bernstein, Lobbestael, & Arntz, 2009). The
occurrence and extent of childhood adversities are measured by the CTQ-SF.
Last, the experienced quality of the patient-doctor relationship is assessed by
the PDRQ-9 (Van der Feltz-Cornelis, Van Oppen, Van Marwijk, De Beurs, & Van
Dyck, 2004).
Childhood trauma questionnaire - Short Form (CTQ-SF; Bernstein et al., 2003)
The Childhood Trauma Questionnaire - Short Form (CTQ-SF) is a 28-item
retrospective self-report questionnaire designed to assess five dimensions of
childhood maltreatment: (1) Physical Abuse, (2) Emotional Abuse, (3) Sexual
Abuse, (4) Physical Neglect, and (5) Emotional Neglect. Items are scored on a
5-point Likert-scale and are structured to reflect the frequency of
maltreatment experiences (never true, rarely true, sometimes true, often true,
very often true). The psychometric properties of the Dutch CTQ-SF were found to
be satisfactory: internal consistencies were Cronbach's alpha .91 for Physical
Abuse, .89 for Emotional Abuse, .95 for Sexual Abuse, .63 for Physical Neglect,
and .91 for Emotional Neglect. In addition, scores on the five CTQ-SF scales
among Dutch respondents showed good convergent validity with responses on a
semi-structured interview for childhood trauma (Thombs et al., 2009).
The other secondary parameter is attachment style. Attachment styles can be
defined as internal working models with a specific set of mental
representations about the self in interaction with others that is developed in
the relationship with primary caregivers (Bowlby, 1969). Attachment styles are
relatively stable over time. In terms of their affective-motivational
characteristics, these global beliefs are referred to as anxiety about
rejection and abandonment and avoidance of intimacy and interdependence
(Crowell, Fraley, & Shaver, 1999). These two dimensions can be combined into
four attachment styles, one secure and three insecure subtypes: preoccupied,
dismissing and fearful (Bartholomew & Horowitz, 1991; Hinnen, Sanderman, &
Sprangers, 2009). Attachment style is measured by the ECR-M16.
The Experiences in Close Relationships Scale - Modified Short Form (ECR-M16;
(Lo et al., 2009)
The ECR-M16 is a 16-item self-report questionnaire designed to assess
attachment patterns in a variety of close relationships. Items are rated on a
likert-scale, ranging from 0 (strongly disagree) to 7 (strongly agree).
Participants receive the instruction ''The following statements concern how you
feel in close relationships with others. In the following statements the term
''other people'' refers to people to whom you feel close. Use the rating scale
to indicate how much you agree or disagree with each statement''. The
psychometric properties of the ECR-M16 were found to be satisfactory. The
internal consistencies of the scales were good, with Cronbach's alpha .83 for
attachment-related avoidance and Cronbach's alpha .84 for attachment-related
anxiety. The correlation between the two subscales was small, r = .27. Finally,
test-retest reliability was satisfactory, with a correlation of .73 for the
attachment avoidance subscale and .82 for the attachment anxiety subscale (Lo
et al., 2009).
Patient Doctor Relationship Questionnaire-9 (PRDQ-9; Van der Feltz-Cornelis et
al., 2004)
The PRDQ-9 is a brief measure of the doctor-patient relationship from the
patients perspective. The nine items are answered on a five-point Likert scale
(1 = not at all appropriate to 5 = totally appropriate). Two sample items are:
*my clinician understands me* and *my clinician and I agree on the nature of my
medical symptoms*. A mean score of all nine items is calculated. A higher score
means more satisfaction about the relationship. The psychometric quality of the
Dutch PDRQ-9 shows good internal consistency, adequate test-retest reliability
and the ability to discriminate between patient groups.
Background summary
Chronic pain is a widespread and an increasingly frequent occurring problem
(Breivik, Collett, Ventafridda, Cohen, & Gallacher, 2006; Hoy et al., 2012).
Patients with chronic pain report a reduced quality of life, as they often
experience great physical discomfort, emotional distress and severe limitations
in daily activities. Also, due to high healthcare utilization, it is a
financial burden on society (Collins et al., 2005; Dagenais, Caro, & Haldeman,
2008; Juniper, Le, & Mladsi, 2009). The International Association for the Study
of Pain (IASP) defines chronic pain as persisting beyond the normal tissue
healing time, usually longer than three months, in the absence of an obvious
underlying biological cause (Merskey & Bogduk, 1994). It is widely agreed upon
that this population is difficult to treat (Allen, Woolfolk, Escobar, Gara, &
Hamer, 2006) and that the patient-doctor relationship is an important factor in
treatment adherence and success (Ciechanowski, Walker, Katon, Russo, 2001) and
in promoting patients resilience (Náfrádi, Kostova, Nakamoto & Schulz, 2018).
Clarification on the underlying mechanisms contributing to the condition is
necessary to define the appropriate aim of treatment, resulting in a more
effective approach.
In the last decades several psychological factors have been found to be
associated with the presence of chronic pain. First, there is increasing
evidence that early-life adversities increase the risk of developing chronic
pain in later life (Burke, Finn, McGuire, & Roche, 2017). Furthermore, it has
been repeatedly demonstrated that attachment insecurity, particularly fearful
and dismissing attachment, is overrepresented in chronic pain populations
(Davies, Macfarlane, McBeth, Morriss, & Dickens, 2009; Hunter & Maunder, 2015;
Kowal et al., 2015; Meredith, Strong, & Feeney, 2005; Meredith, Strong, &
Feeney, 2006; Schmidt, Nachtigall, Wuethrich-Martone, & Strauss, 2002).
Moreover, empirical evidence suggests that mentalization partly explains the
relationship between on the one hand early life adversities and insecure
attachment and on the other hand somatoform symptoms, including chronic pain
(Hunter & Maunder, 2015).
Mentalizing is the ability to understand behavior in terms of internal mental
states such as thoughts, feelings, needs and desires (Luyten & Fonagy, 2014).
Previous research suggests that early life adversities and insecure attachment
are associated with difficulties in mentalization (Hunter & Maunder, 2015).
Moreover, earlier studies suggest that mentalization is associated with
experiencing more physical complaints, such as chronic pain (De Gucht & Heiser,
2003). Furthermore, mentalization has a fundamental impact on interpersonal
functioning (Hayden et al., 2018). Since patients with chronic pain often have
difficulties in mentalizing (Spaans, Veselka, Luyten & Buhring, 2009), forming
an effective and satisfactory relationship with their doctor may be complicated
(Matthias & Bair, 2010).
Previous studies on mentalization and chronic pain are limited due to
methodological problems, such as inappropriate self-report questionnaires and
small sample sizes. Self-report questionnaires are suboptimal as they measure
how a person perceives him or herself, with somatoform patients often having
poor introspective capacities and showing favorable self-presentations (Wineke,
Eurelings-Bontekoe, Van Dijke, Van Gool, & Moene, 2015). Few studies have used
more appropriate performance-based measures in which results are obtained by
observing a person complete an activity. Till date only two studies have used
performance-based measures to assess mentalization in chronic pain patients
(Schönenberg et al., 2014; Zunhammer, Halski, Eichhammer, & Busch, 2015). These
studies suggest that inpatients with chronic pain are impaired in mentalizing.
However, this is not generalizable to the much larger group of patients who are
treated in an outpatient clinic, since these patients are often less affected
by the condition than inpatients. Moreover, these studies did not include other
psychological factors (e.g. early life adversities and attachment) that may
help to identify who is at risk of experiencing chronic pain and which may be a
focus of attention in treatment. Furthermore, none of the earlier studies
included a control group consisting of patients with somatically explained pain
symptoms. Consequently, it has been difficult to conclude whether the deficits
in mentalizing abilities contribute to the development of chronic pain
complaints or conversely, that suffering from painful physical conditions may
lead to difficulties in mentalizing.
The aim of the present study is to examine the differences in mentalizing
abilities between an outpatient group with chronic pain and a control group,
consisting of patients with painful acute injuries or painful somatically
explained conditions. The use of a control group with overall more somatically
explained pain symptoms, is necessary to control for the experiencing of pain,
this possible effecting mentalizing ability. We will use several
performance-based tasks to assess mentalization. Our first hypothesis is that
outpatients with chronic pain will manifest poorer mentalizing abilities than
the control group. Furthermore, we hypothesize that mentalization mediates the
association between childhood adversities and attachment style on the one hand
and patient group on the other hand. The third hypothesis is that mentalization
mediates the association between attachment style and the quality of the
patient-doctor relationship. Our findings could raise the possibility that
persons with chronic pain are more often burdened with a fundamental mental
deficit in the ability of mentally representing one*s own and others* emotional
states. This would require interventions aimed at this fundamental problem,
with a variety of treatments suitable for this purpose, such as Mentalization
Based Treatment, Focusing, Emotion-Focused Psychotherapy and Dialectical
Behavior Therapy. To date, these techniques have not been recognized as
treatments for chronic pain, because the latter has not been previously thought
to be due to a deficit in mental representation of emotions (Subic-Wrana et
al., 2010).
Study objective
The primary objective is to investigate the differences in mentalizing
abilities between outpatients with chronic pain and a control group, consisting
of outpatients with painful acute injuries or painful somatically explained
conditions. The secondary objective is to examine whether mentalization
mediates the association between childhood adversities and attachment style on
the one hand and the presence of chronic pain on the other hand. The third
objective is to examine whether mentalization mediates the association between
attachment style and how patients experience the relationship with their
doctor.
Study design
The design of the study is a case-control design. Mentalizing ability will be
measured once, before participants start their treatment program. The
mentalizing ability of two groups will be compared: the case groups, consisting
of patients with chronic pain and the control group, consisting of patients
with painful acute injuries or painful somatically explained conditions. This
specific control group is necessary, since none of the earlier studies included
a control group consisting of patients with painful somatically explained pain
symptoms. Consequently, it has been difficult to conclude whether the deficits
in mentalizing abilities contribute to the development of chronic pain
complaints or conversely, that suffering from painful physical conditions may
lead to difficulties in mentalizing.
Study burden and risks
There are no risks associated with participation. The burden for participants
will be kept minimal; at one moment in time, at the beginning of the treatment
programs, the care as usual will be supplemented with five short questionnaires
and two tasks, for the duration of approximately one hour. No incentives will
be distributed, since all participants will volunteer without compensation. No
extra travel expenses will be made, because the appointment for the study will
be matched to existing appointments in the hospital that are part of the care
as usual. Participants do receive compensation for extra parking costs, since
they are one hour longer in the hospital for the purpose of the current study.
Maatweg 3
Amersfoort 3813TZ
NL
Maatweg 3
Amersfoort 3813TZ
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria per group:, Case group: referred for treatment and diagnosed
with chronic pain by a rehabilitation/pain specialist. Chronic pain is
diagnosed when complaints are lasting for at least three months, persisting
beyond the normal tissue healing time and in the absence of an obvious
underlying biological cause. Control group: referred for treatment and
diagnosed by the rehabilitation/pain specialist with a painful acute injury or
a painful condition that can be somatically explained. Inclusion criteria for
both groups: age between 18 and 65 years and ability to speak Dutch.
Exclusion criteria
The exclusion criteria for both groups are: younger than 18 years or older than
65 years, inability to speak Dutch, diagnosed mental retardation, substantial
cognitive impairments, current major psychiatric disorders and substance abuse
(other than pain medication). It is important to note that mild and moderate
anxiety and/or depressive symptoms do not result in exclusion.
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 |
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CCMO | NL68149.100.18 |