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Effectiveness of Psychological Interventions in Haemophilia

Not Applicable
Completed
Conditions
Haemophilia
Interventions
Behavioral: Hypnosis
Behavioral: Cognitive-Behavioral Therapy
Registration Number
NCT02870452
Lead Sponsor
University of Minho
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
20
Inclusion Criteria
  • Mild pr severe Haemophilia A or B
  • Age of 18 or older
  • Ability to write and read
Exclusion Criteria
  • Other comorbid life threatening diseases, such as cancer
  • Neurological or psychiatric deficits
  • Acquired Haemophilia

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
HypnosisHypnosisHypnosis for the prevention and management of pain, emotional regulation and promotion of quality of life in people with Haemophilia
Cognitive-Behavioral TherapyCognitive-Behavioral TherapyCognitive Behavioral Therapy for the prevention and management of pain, emotional regulation and promotion of quality of life in people with Haemophilia
Primary Outcome Measures
NameTimeMethod
Pain intensity at 1 week as assessed by Numeric Rating Scale (NRS)1 week post-intervention
Pain intensity at 3 months as assessed by NRS3 months post-intervention
Pain intensity at 6 months as assessed by NRS6 months post-intervention
Pain intensity at 12 months as assessed by NRS12 months post-intervention
Secondary Outcome Measures
NameTimeMethod
Depression at 3 months as assessed by PROMIS-Depression Short Form v1.03 months
Depression at 6 months as assessed by PROMIS-Depression Short Form v1.06 months
Depression at 12 months as assessed by PROMIS-Depression Short Form v1.012 months
Pain Catastrophizing at 1 week as assessed by Coping Strategies Questionnaire (CSQ) Catastrophizing Subscale1 week
Pain Catastrophizing at 3 months as assessed by CSQ Catastrophizing Subscale3 months
Pain Catastrophizing at 6 months as assessed by CSQ Catastrophizing Subscale6 months
HRQOL at 3 months as assessed by A36Hemofilia-Qol3 months
HRQOL at 6 months as assessed by A36Hemofilia-Qol6 months
Haemophilia related functional limitations at 6 months as assessed by HAL6 months
Anxiety at 6 months as assessed by PROMIS-Anxiety Short Form v1.06 months
Anxiety at 12 months as assessed by PROMIS-Anxiety Short Form v1.012 months
Health Related Quality of Life (HRQOL) at 1 week as assessed by A36Hemofilia-Qol1 week
Depression at 1 week as assessed by PROMIS-Depression Short Form v1.01 week
HRQOL at 12 months as assessed by A36Hemofilia-Qol12 months
Haemophilia related functional limitations at 1 week as assessed by Haemophilia Activities List (HAL)1 week
Haemophilia related functional limitations at 3 months as assessed by HAL3 months
Haemophilia related functional limitations at 12 months as assessed by HAL12 months
Anxiety at 1 week as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety Short Form v1.01 week
Anxiety at 3 months as assessed by PROMIS-Anxiety Short Form v1.03 months
Pain Catastrophizing at 12 months as assessed by CSQ Catastrophizing Subscale12 months
Illness Perception (Personal Control) at 1 week as assessed by Revised Illness Perception Questionnaire (IPQ-R)1 week
Illness Perception (Emotional Representation) at 1 week as assessed by IPQ-R1 week
Illness Perception (Personal Control) at 3 months as assessed by IPQ-R3 months
Illness Perception (Emotional Representation) at 3 months as assessed by IPQ-R3 months
Illness Perception (Personal Control) at 6 months as assessed by IPQ-R6 months
Illness Perception (Emotional Representation) at 6 months as assessed by IPQ-R6 months
Illness Perception (Personal Control) at 12 months as assessed by IPQ-R12 months
Illness Perception (Emotional Representation) at 12 months as assessed by IPQ-R12 months
Number of joint bleeds in the previous month, at 1 week1 week
Number of joint bleeds in the previous month, at 3 months3 months
Number of joint bleeds in the previous month, at 6 months6 months
Number of joint bleeds in the previous month, at 12 months12 months
Analgesic intake in the previous month, at 1 week1 week
Analgesic intake in the previous month, at 3 months3 months
Analgesic intake in the previous month, at 6 months6 months
Analgesic intake in the previous month, at 12 months12 months
Replacement factor (VIII/IX) consumption in the previous month, at 1week1 week
Replacement factor (VIII/IX) consumption in the previous month, at 3 months3 months
Replacement factor (VIII/IX) consumption in the previous month, at 6 months6 months
Replacement factor (VIII/IX) consumption in the previous month, at 12 months12 months
Pettersson Score at 3 months3 months

Radiologic classification of PWH joint status

Pettersson Score at 12 months12 months

Radiologic classification of PWH joint status

Gilbert Score at 3 months3 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

Gilbert Score at 12 months12 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

IL-6 Cytokine at 3 months3 months
IL-6 Cytokine at 12 months12 months
IL-1β Cytokine at 6 months6 months
IL-1β Cytokine at 12 months12 months
C Reactive Protein at 6 months6 months
C Reactive Protein at 12 months12 months
IL-10 Cytokine at 6 months6 months
IL-10 Cytokine at 12 months12 months
TNF-α Cytokine at 6 months6 months
TNF-α Cytokine at 12 months12 months

Trial Locations

Locations (1)

Life and Health Sciences Research Institute

🇵🇹

Braga, Portugal

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