Effectiveness of Psychological Interventions in Haemophilia

Overview

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.

Full Title of Study: “Effectiveness of Two Psychological Interventions for Prevention and Management of Pain, Emotional Regulation and Promotion of Quality of Life in People With Haemophilia: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2018

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.

Interventions

  • Behavioral: Hypnosis
    • 4 weekly individual sessions of Hypnosis, conducted by a certified psychologist, with the approximate duration of 90 minutes.
  • Behavioral: Cognitive-Behavioral Therapy
    • 4 weekly individual sessions of CBT, conducted by a certified psychologist, with the approximate duration of 90 minutes.

Arms, Groups and Cohorts

  • Experimental: Hypnosis
    • Hypnosis for the prevention and management of pain, emotional regulation and promotion of quality of life in people with Haemophilia
  • Experimental: Cognitive-Behavioral Therapy
    • Cognitive Behavioral Therapy for the prevention and management of pain, emotional regulation and promotion of quality of life in people with Haemophilia
  • No Intervention: Control Group
    • No psychological intervention – standard Haemophilia care

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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
  • 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
    • Time Frame: 3 months
    • Radiologic classification of PWH joint status
  • Pettersson Score at 12 months
    • Time Frame: 12 months
    • Radiologic classification of PWH joint status
  • Gilbert Score at 3 months
    • Time Frame: 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
  • Gilbert Score at 12 months
    • Time Frame: 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Minho
  • Collaborator
    • Hospital Sao Joao
  • Provider of Information About this Clinical Study
    • Principal Investigator: Patrícia Ribeiro Pinto, Post-doctoral fellow – University of Minho
  • Overall Official(s)
    • Patrícia R Pinto, PhD, Principal Investigator, Life and Health Sciences Research Institute

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