Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01025908 |
| Other study ID # |
LABPR |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
December 3, 2009 |
| Last updated |
January 29, 2010 |
| Start date |
May 2006 |
| Est. completion date |
April 2007 |
Study information
| Verified date |
December 2009 |
| Source |
Universidade Federal do Rio de Janeiro |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Brazil: Ethics Committee |
| Study type |
Interventional
|
Clinical Trial Summary
The objective of this study in cognitive-behavioural therapy (CBT) was to demonstrate the
preparation of the patient with panic disorder for agoraphobic exposures. The focus of the
work consisted of interoceptive exposures, in vivo, of body sensations themselves, to feared
places and situations. The sample consisted of 50 individuals. Group 1 undertook 10 weekly,
individual sessions of CBT of one hour duration. Group 2, control, was just follow-up with
supportive therapy. The procedures used for the exposures, especially for induction symptom
exercises, were considered essential in the preparation of patients with panic disorder, to
be able to face up to panic attacks and subsequent agoraphobic situations.
Description:
The patients with PDA were diagnosed by medical psychiatrists from the team at the
Respiration and Panic Laboratory of Instituto de Psiquiatria da Universidade Federal do Rio
de Janeiro (IPUB/UFRJ), INCT Translational Medicine, according to the criteria of diagnostic
of the Manual of Diagnostic and Statistics of Mental Disorder (DSM-IV-TR, 2002b) and
according to the evaluation instrument SCID-I (Structured Clinical Interview Diagnostic)
(First et al, 1997). The sample consisted of 50 voluntary patients divided in two Groups.
The 1st Group, made up of 25 individuals, received 10 sessions of CBT. The 2nd Group,
"control", also consisted of 25 patients, who received just supportive psychotherapy.
With a view to comparing the results of the Groups after the interventions, the following
evaluation instruments were applied at the beginning and at the end of the research: Beck
Anxiety Inventory (Beck et al, 1998a); State-Trait Anxiety Inventory (Spielberg et al,
1970); Sheehan Disability Scale (Sheeham, 1983a); Global Assessment of Functioning (AXIS V)
(DSM-IV-TR, 2002c); questionnaire of fears and phobias (Mark & Mathews, 1979); questionnaire
of cognitive agoraphobias( Chambless, 1984a); questionnaire of body sensations (Chambless,
1984b) and Panic and Agoraphobia Scale (Bandelow, 1999a).
The criteria for inclusion in the research was patients over 18 years old of both sexes with
a diagnosis of PDA, with no serious comorbidities. The patients that presented alcohol or
drug dependency, mental retardation or serious mental disorders were excluded from the
research.
The patients who agreed to participate in the study, signed a "Term of Free and Clarified
Consent" and were made aware of all the procedures undertaken, approved by the Committee of
Ethics for the research IPUB/UFRJ.
In the evaluation of the tests the Chi-square tests ( χ2 ) or ANOVA, depending on the type
of variable measure, always with 95% of Confidence, or P-Value ≤ 0,05. In the
characterization of the Groups, the tests were undertaken with the values identified at the
beginning of the treatment. Thus, the efficiency of the initiatives undertaken could be
perceived. The objective was to identify the significant statistical differences, between
the initial and final results of the tests.
The 10 CBT sessions were based on the previous study (King et al, 2007a), with some
modifications and adaptations appropriate to the characteristics of the sample of the
patients under study. The content of the sessions were distributed in the following way: PD
education (including the educational concepts of anxiety, agoraphobia, panic,
hyperventilation, respiratory re-education exercises (RR exercises), progressive muscular
relaxation exercises (PMR exercises), preparation of a scale of "patient fears" from the
smallest to greatest to cause anxiety, identification of cognitive distortions, cognitive
restructuring (CR), symptom induction exercises (SIE), IE, IVE, reinforcement of conquests,
observation of the difficulties in the procedures and maintenance of treatment gains.
The patients were encouraged to apply cognitive strategies at home, such as expose
themselves to changes of temperature, physical exercise, amongst others, several times, with
the purpose of inducing and tolerating the sensations with no therapeutic assistance.
The learning in the first phase of the treatment that BS related to panic are not really
dangerous is essential to overcoming of agoraphobia and for the control of panic.
Standard model of the 10 CBT sessions:
1. st. Session: Education concerning the trajectory of PD and the preparation of a
priority list of feared situations by the patient. Instructions to the patient of
relaxation techniques, repeated whenever necessary. RR exercise: Placing ones hand
above ones stomach, feeling the air passing through the diaphragm, perception of the
abdominal movement at each respiration. Slow inspiration through the nose counting up
to three, holding the respiration, counting up to three, and releasing the air slowly
through the mouth counting up to six. Repetition of the exercise several times in a
row. In continuity, Progressive Muscular Relaxation (PMR) (Jacobson, 1938) is
undertaken with the individual, whereby the instructor seeks to exercise by tensioning
four Groups of muscles for ten seconds and immediately after relaxing for another ten
seconds. The latter are: 1st face; 2nd arms, shoulders, chest and neck; 3rd abdomen,
spine, genital organs and 4th legs and feet.
2. nd. Session: explanation concerning the physiological mechanism of "fight and flight"
(Barlow, 1988b), verification of the similarity between the sensation originating from
this mechanism, compared with BS that emerge from panic. Undertake RR exercise, used
constantly during the sessions. When one manages to alter the thoughts referring to the
capacity to deal with feared situations, one is capable of controlling the physical
symptoms.
3. rd. Session: model of hyperventilation that delineated by the rhythm and depth of the
exaggerated respiration for the needs of the body at a specific given moment. The
latter was undertaken with a patient sitting in a position of SIE hyperventilation:
patient inspires and expires deeply for 90 seconds, observation of patient reactions
and explanation of the reason for the emerging symptoms. Undertaking of RR exercise.
The patient should understand that anticipated anxiety is characterized by anticipated
thought processes, generally negative, of feared situations. Even in a secure situation
if the mind interprets it as insecure, the body will react with a message of danger
producing symptoms.
4. th. Session: SIE: -sitting, look fixedly at a light for a minute and afterwards
standing up quickly and trying to read something. Analysis with the patient of the
sensations present and the levels of negative, catastrophic and repetitive thoughts
that have occurred. The patient begins to understand the origin of the symptoms and to
perceive that they are inoffensive, learning to deal with them. In continuity, RR
exercise is administered.
5. th. Session: explanation of the concepts of BS that can be accentuated due to a
situation or to substances. Examples: exercising oneself or moving oneself quickly,
brusque changes of temperature, bright light, use of caffeine, alcohol, medicines and
irregular levels of respiration. Panic has it root in the fear of physical sensations
(Rangé, 2001b).
A patient was submitted to SIE: turning around in circles for a minute, afterwards
stopping, understanding and giving a new positive significance to the reactions
verified.
Immediately after, RR exercise is administered.
6. th. Session: in PA some of the patient complaints were: ex: "I cannot breathe", or "I
am going to suffocate". It was explained that it is natural to breathe excessively when
one is anxious. The body seeks more energy in the form of oxygen to prepare itself to
deal with danger. When the oxygen is not used in the same proportion in which it is
consumed, the result is hyperventilation. The concepts of hyperventilation are
remembered and SIE of the 4th session is repeated, followed by RR exercise.
7. th. Session: education concerning CR - The way events are interpreted is what
determines the nature of the resulting emotional reactions (Rangé, 2001c). The patient
should try to identify and give a new significance to the specific badly-adapted
cognations. The concepts of Anticipated Anxiety (AA) and agoraphobic avoidance (PA-aa)
(Beck, 1994) were clarified. Patients have the custom of myths in relation to PA: "I
think I am going to lose control", "I think I am going to die", "I think I am going to
have a heart attack", I think I am going mad", amongst others. The patient is
instructed to question and contest his or her conjectures and beliefs concentrating on
the realistic probabilities and gather evidence and forms to deal with the events.
8. th.Session: The IE refers to the fear learnt of internal state. Certain sensations of
terror, similar to fear previously experienced, have the custom of indicating new
possible PA (Muotri et al, 2007c). The automatic stimulus generated intensifies the
feared sensations, creating a vicious circle. Undertake two SIE: Sitting down, place
the patient's head between his or her legs for 30 seconds, afterwards sit up quickly
and look to the ceiling. And other exercise: the patient holds his or her respiration
until it can no longer be held while turning round in circles for 30 seconds. In
continuity, analysis of the symptoms and trying to understand the originating causes.
RR exercise is undertaken.
9. th. Session: Undertake three SIE: repeat the exercise of the 5th session and the two of
the 8th session with subsequent administration of RR exercise. The purpose being for
the individual to associate the symptom with the cause, explain that the symptoms
emerge from physiological alterations triggered for some reason, differently from what
one thought that BS emerged from nowhere, with no apparent reason. Previously, the
patient would make a distorted association of the facts, interpreting tachycardia,
perspiration, lack of breath, among others, as a sign of imminent death or loss of
control and not as resulting from specific triggering factors.
10. th. Session: one SIE: the patient standing up turns his or her head from one side to
the other for 30 seconds, stops and tries to fix his or her eyes on a spot on the wall.
Repeat this exercise after SIE of the 3rd session, in continuity; recover the patient's
physical balance and respiration with RR or PMR exercises. Evaluate the IVE concept
regarding confronting the patient with agoraphobic situations or locations. Explain
that agoraphobia is maintained by the fear of panicking or the experience of certain
BS.
Real confrontation with the feared situation is repeated with each item of the priority list
of the patient's fears, beginning with the least anxiety provocative, until reaching the
most feared. Ask the patient to practise IVE whenever there is an opportunity.
Review the IVEs undertaken, encourage the practical repetitions, and discuss the
difficulties in the procedures. The behaviour of exceeding oneself should be encouraged
instead of unnecessary over precautions. Remind the patient that to run away from the IVE
reinforces the maintenance of fear. The therapist stimulates thoughts concerning the avoided
tasks and helps the patient with CR. The fact that the additional diagnostics have the
tendency to decline after PD treatment should be commented. Ex: comorbidities such as
depression, generalized anxiety and social phobia. Reaffirm that the fear response is
inoffensive, passing and controllable, the BS appear and disappear, without the need of
being avoided.
After the end of all the stages of the research, the two Groups were re-evaluated with same
initial instruments. The Groups were compared, observing the changes that had occurred, the
benefits, the losses and differences that had occurred because Group 1 had received
accompaniment with CBT and medication, compared to Group 2 control that had only made use of
medication with no CBT.
