The purpose of this study is to evaluate the relative effectiveness of two psychological interventions, cognitive-behavioral therapy (CBT) and hypnosis (Hyp), in preventing and managing pain, regulating emotional state and improving quality of life in Portuguese PWH.
22 (People with Haemophilia) PWH will be included in each group (Hypnosis, CBT and control-no intervention) (total=66). Sample size was calculated using G\*Power 3.1.4 and considering the following assumptions: to perform a one-way ANOVA with fixed effects, a large effect size (f =0.4), a significance level (α - type I error) of 0.05 and a statistical power (1-β - type II error) of 0.80. The patients will be approached by clinicians of the Immunohaemotherapy Department and the psychologists for the explanation of the study, confidentiality and voluntary nature of participation. Patients who agree to participate will be asked to read and sign the Informed Consent document. Afterwards, the first assessment moment will take place in order to get a baseline assessment of each patient (T0: pre-test). Subsequently, the blind randomization to one of the 3 conditions will occur and the 4 individual intervention sessions will be scheduled, occurring in a weekly basis (90 minutes per session). The post-test assessment (T1) takes place one week after the last intervention session (in the 5th week), and the follow-up assessments (T2, T3 and T4) will occur subsequently at 3 months, 6 months and one year post-intervention. A physiological assessment will be performed at T1, T2 and T4. This will be performed through the collection of blood samples in order to achieve a systemic evaluation of pro-inflammatory and anti-inflammatory cytokines. A CBC (Complete Blood Count) with White Blood Count and C Reactive Protein (CRP) analysis will also be performed. Upon arrival at the Immunohaemotherapy Department (between 9:30 am and 1:30 pm), patients will undergo sample blood collection and EDTA-samples will be transported immediately to the lab. In the lab, blood samples are centrifuged 15 minutes at 3.000 rpm, and plasma aliquoted and stored in a freezer at -80 ºC, until further analysis. Plasma levels of cytokines (IL-6, IL-1β, TNF-α, IL-10) are assayed in duplicate using ultra-sensitive multiplex human ELISA kits (Life Technologies®). Functional Assessment of the joints will be performed through the Gilbert (based on clinical evaluation) and Pettersson Scores (based on X-ray and ultrasonography). All study procedures will comply with the applicable ethical guidelines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
20
4 weekly individual sessions of Hypnosis, conducted by a certified psychologist, with the approximate duration of 90 minutes.
4 weekly individual sessions of CBT, conducted by a certified psychologist, with the approximate duration of 90 minutes.
Life and Health Sciences Research Institute
Braga, Portugal
Pain intensity at 1 week as assessed by Numeric Rating Scale (NRS)
Time frame: 1 week post-intervention
Pain intensity at 3 months as assessed by NRS
Time frame: 3 months post-intervention
Pain intensity at 6 months as assessed by NRS
Time frame: 6 months post-intervention
Pain intensity at 12 months as assessed by NRS
Time frame: 12 months post-intervention
Health Related Quality of Life (HRQOL) at 1 week as assessed by A36Hemofilia-Qol
Time frame: 1 week
HRQOL at 3 months as assessed by A36Hemofilia-Qol
Time frame: 3 months
HRQOL at 6 months as assessed by A36Hemofilia-Qol
Time frame: 6 months
HRQOL at 12 months as assessed by A36Hemofilia-Qol
Time frame: 12 months
Haemophilia related functional limitations at 1 week as assessed by Haemophilia Activities List (HAL)
Time frame: 1 week
Haemophilia related functional limitations at 3 months as assessed by HAL
Time frame: 3 months
Haemophilia related functional limitations at 6 months as assessed by HAL
Time frame: 6 months
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Haemophilia related functional limitations at 12 months as assessed by HAL
Time frame: 12 months
Anxiety at 1 week as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety Short Form v1.0
Time frame: 1 week
Anxiety at 3 months as assessed by PROMIS-Anxiety Short Form v1.0
Time frame: 3 months
Anxiety at 6 months as assessed by PROMIS-Anxiety Short Form v1.0
Time frame: 6 months
Anxiety at 12 months as assessed by PROMIS-Anxiety Short Form v1.0
Time frame: 12 months
Depression at 1 week as assessed by PROMIS-Depression Short Form v1.0
Time frame: 1 week
Depression at 3 months as assessed by PROMIS-Depression Short Form v1.0
Time frame: 3 months
Depression at 6 months as assessed by PROMIS-Depression Short Form v1.0
Time frame: 6 months
Depression at 12 months as assessed by PROMIS-Depression Short Form v1.0
Time frame: 12 months
Pain Catastrophizing at 1 week as assessed by Coping Strategies Questionnaire (CSQ) Catastrophizing Subscale
Time frame: 1 week
Pain Catastrophizing at 3 months as assessed by CSQ Catastrophizing Subscale
Time frame: 3 months
Pain Catastrophizing at 6 months as assessed by CSQ Catastrophizing Subscale
Time frame: 6 months
Pain Catastrophizing at 12 months as assessed by CSQ Catastrophizing Subscale
Time frame: 12 months
Illness Perception (Personal Control) at 1 week as assessed by Revised Illness Perception Questionnaire (IPQ-R)
Time frame: 1 week
Illness Perception (Emotional Representation) at 1 week as assessed by IPQ-R
Time frame: 1 week
Illness Perception (Personal Control) at 3 months as assessed by IPQ-R
Time frame: 3 months
Illness Perception (Emotional Representation) at 3 months as assessed by IPQ-R
Time frame: 3 months
Illness Perception (Personal Control) at 6 months as assessed by IPQ-R
Time frame: 6 months
Illness Perception (Emotional Representation) at 6 months as assessed by IPQ-R
Time frame: 6 months
Illness Perception (Personal Control) at 12 months as assessed by IPQ-R
Time frame: 12 months
Illness Perception (Emotional Representation) at 12 months as assessed by IPQ-R
Time frame: 12 months
Number of joint bleeds in the previous month, at 1 week
Time frame: 1 week
Number of joint bleeds in the previous month, at 3 months
Time frame: 3 months
Number of joint bleeds in the previous month, at 6 months
Time frame: 6 months
Number of joint bleeds in the previous month, at 12 months
Time frame: 12 months
Analgesic intake in the previous month, at 1 week
Time frame: 1 week
Analgesic intake in the previous month, at 3 months
Time frame: 3 months
Analgesic intake in the previous month, at 6 months
Time frame: 6 months
Analgesic intake in the previous month, at 12 months
Time frame: 12 months
Replacement factor (VIII/IX) consumption in the previous month, at 1week
Time frame: 1 week
Replacement factor (VIII/IX) consumption in the previous month, at 3 months
Time frame: 3 months
Replacement factor (VIII/IX) consumption in the previous month, at 6 months
Time frame: 6 months
Replacement factor (VIII/IX) consumption in the previous month, at 12 months
Time frame: 12 months
Pettersson Score at 3 months
Radiologic classification of PWH joint status
Time frame: 3 months
Pettersson Score at 12 months
Radiologic classification of PWH joint status
Time frame: 12 months
Gilbert Score at 3 months
Joint health evaluation, in the domain of body structure and function (i.e. impairment), of the joints most commonly affected by bleeding in hemophilia - knees, ankles, elbows
Time frame: 3 months
Gilbert Score at 12 months
Joint health evaluation, in the domain of body structure and function (i.e. impairment), of the joints most commonly affected by bleeding in hemophilia - knees, ankles, elbows
Time frame: 12 months
IL-6 Cytokine at 3 months
Time frame: 3 months
IL-6 Cytokine at 12 months
Time frame: 12 months
IL-1β Cytokine at 6 months
Time frame: 6 months
IL-1β Cytokine at 12 months
Time frame: 12 months
IL-10 Cytokine at 6 months
Time frame: 6 months
IL-10 Cytokine at 12 months
Time frame: 12 months
TNF-α Cytokine at 6 months
Time frame: 6 months
TNF-α Cytokine at 12 months
Time frame: 12 months
C Reactive Protein at 6 months
Time frame: 6 months
C Reactive Protein at 12 months
Time frame: 12 months