Effectiveness of Psychological Interventions in Haemophilia
- Conditions
- Haemophilia
- Interventions
- Behavioral: HypnosisBehavioral: 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
- Mild pr severe Haemophilia A or B
- Age of 18 or older
- Ability to write and read
- Other comorbid life threatening diseases, such as cancer
- Neurological or psychiatric deficits
- Acquired Haemophilia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hypnosis Hypnosis Hypnosis for the prevention and management of pain, emotional regulation and promotion of quality of life in people with Haemophilia Cognitive-Behavioral Therapy 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
- Primary Outcome Measures
Name Time Method Pain intensity at 1 week as assessed by Numeric Rating Scale (NRS) 1 week post-intervention Pain intensity at 3 months as assessed by NRS 3 months post-intervention Pain intensity at 6 months as assessed by NRS 6 months post-intervention Pain intensity at 12 months as assessed by NRS 12 months post-intervention
- Secondary Outcome Measures
Name Time Method Depression at 3 months as assessed by PROMIS-Depression Short Form v1.0 3 months Depression at 6 months as assessed by PROMIS-Depression Short Form v1.0 6 months Depression at 12 months as assessed by PROMIS-Depression Short Form v1.0 12 months Pain Catastrophizing at 1 week as assessed by Coping Strategies Questionnaire (CSQ) Catastrophizing Subscale 1 week Pain Catastrophizing at 3 months as assessed by CSQ Catastrophizing Subscale 3 months Pain Catastrophizing at 6 months as assessed by CSQ Catastrophizing Subscale 6 months HRQOL at 3 months as assessed by A36Hemofilia-Qol 3 months HRQOL at 6 months as assessed by A36Hemofilia-Qol 6 months Haemophilia related functional limitations at 6 months as assessed by HAL 6 months Anxiety at 6 months as assessed by PROMIS-Anxiety Short Form v1.0 6 months Anxiety at 12 months as assessed by PROMIS-Anxiety Short Form v1.0 12 months Health Related Quality of Life (HRQOL) at 1 week as assessed by A36Hemofilia-Qol 1 week Depression at 1 week as assessed by PROMIS-Depression Short Form v1.0 1 week HRQOL at 12 months as assessed by A36Hemofilia-Qol 12 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 HAL 3 months Haemophilia related functional limitations at 12 months as assessed by HAL 12 months Anxiety at 1 week as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety Short Form v1.0 1 week Anxiety at 3 months as assessed by PROMIS-Anxiety Short Form v1.0 3 months Pain Catastrophizing at 12 months as assessed by CSQ Catastrophizing Subscale 12 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-R 1 week Illness Perception (Personal Control) at 3 months as assessed by IPQ-R 3 months Illness Perception (Emotional Representation) at 3 months as assessed by IPQ-R 3 months Illness Perception (Personal Control) at 6 months as assessed by IPQ-R 6 months Illness Perception (Emotional Representation) at 6 months as assessed by IPQ-R 6 months Illness Perception (Personal Control) at 12 months as assessed by IPQ-R 12 months Illness Perception (Emotional Representation) at 12 months as assessed by IPQ-R 12 months Number of joint bleeds in the previous month, at 1 week 1 week Number of joint bleeds in the previous month, at 3 months 3 months Number of joint bleeds in the previous month, at 6 months 6 months Number of joint bleeds in the previous month, at 12 months 12 months Analgesic intake in the previous month, at 1 week 1 week Analgesic intake in the previous month, at 3 months 3 months Analgesic intake in the previous month, at 6 months 6 months Analgesic intake in the previous month, at 12 months 12 months Replacement factor (VIII/IX) consumption in the previous month, at 1week 1 week Replacement factor (VIII/IX) consumption in the previous month, at 3 months 3 months Replacement factor (VIII/IX) consumption in the previous month, at 6 months 6 months Replacement factor (VIII/IX) consumption in the previous month, at 12 months 12 months Pettersson Score at 3 months 3 months Radiologic classification of PWH joint status
Pettersson Score at 12 months 12 months Radiologic classification of PWH joint status
Gilbert Score at 3 months 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 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 3 months IL-6 Cytokine at 12 months 12 months IL-1β Cytokine at 6 months 6 months IL-1β Cytokine at 12 months 12 months C Reactive Protein at 6 months 6 months C Reactive Protein at 12 months 12 months IL-10 Cytokine at 6 months 6 months IL-10 Cytokine at 12 months 12 months TNF-α Cytokine at 6 months 6 months TNF-α Cytokine at 12 months 12 months
Trial Locations
- Locations (1)
Life and Health Sciences Research Institute
🇵🇹Braga, Portugal