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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Minho
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Pain intensity at 1 week as assessed by Numeric Rating Scale (NRS)
Study Overview
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®).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Hypnosis
Hypnosis for the prevention and management of pain, emotional regulation and promotion of quality of life in people with Haemophilia
Intervention: Hypnosis (Behavioral)
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
Intervention: Cognitive-Behavioral Therapy (Behavioral)
Control Group
No psychological intervention - standard Haemophilia care
Outcomes
Primary Outcomes
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 Outcomes
- Haemophilia related functional limitations at 3 months as assessed by HAL(3 months)
- Anxiety at 12 months as assessed by PROMIS-Anxiety Short Form v1.0(12 months)
- Depression at 1 week as assessed by PROMIS-Depression Short Form v1.0(1 week)
- Depression at 3 months as assessed by PROMIS-Depression Short Form v1.0(3 months)
- Health Related Quality of Life (HRQOL) at 1 week as assessed by A36Hemofilia-Qol(1 week)
- HRQOL at 3 months as assessed by A36Hemofilia-Qol(3 months)
- HRQOL at 6 months as assessed by A36Hemofilia-Qol(6 months)
- Illness Perception (Emotional Representation) at 6 months as assessed by IPQ-R(6 months)
- 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 6 months as assessed by HAL(6 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)
- Anxiety at 6 months as assessed by PROMIS-Anxiety Short Form v1.0(6 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)
- 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 (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)
- 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)
- 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)
- Pettersson Score at 12 months(12 months)
- Gilbert Score at 3 months(3 months)
- Gilbert Score 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)
Investigators
Patrícia Ribeiro Pinto
Post-doctoral fellow
University of Minho