Clinical trial NCT02870452: Effectiveness of Psychological Interventions in Haemophilia
Official title: 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: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Haemophilia
Keywords: Haemophilia
RCT
Pain
Hemarthrosis
Hypnosis
Cognitive-Behavioral Therapy
Quality of Life
Distress
Cytokines
Lead sponsor: University of Minho
Sponsor class: OTHER
Collaborators: name: Hospital Sao Joao
First posted: 2016-08-17
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity at 1 week as assessed by Numeric Rating Scale (NRS)
timeFrame: 1 week post-intervention
measure: Pain intensity at 3 months as assessed by NRS
timeFrame: 3 months post-intervention
measure: Pain intensity at 6 months as assessed by NRS
timeFrame: 6 months post-intervention
measure: Pain intensity at 12 months as assessed by NRS
timeFrame: 12 months post-intervention
Secondary outcomes:
measure: Health Related Quality of Life (HRQOL) at 1 week as assessed by A36Hemofilia-Qol
timeFrame: 1 week
measure: HRQOL at 3 months as assessed by A36Hemofilia-Qol
timeFrame: 3 months
measure: HRQOL at 6 months as assessed by A36Hemofilia-Qol
timeFrame: 6 months
measure: HRQOL at 12 months as assessed by A36Hemofilia-Qol
timeFrame: 12 months
measure: Haemophilia related functional limitations at 1 week as assessed by Haemophilia Activities List (HAL)
timeFrame: 1 week
measure: Haemophilia related functional limitations at 3 months as assessed by HAL
timeFrame: 3 months
measure: Haemophilia related functional limitations at 6 months as assessed by HAL
timeFrame: 6 months
measure: Haemophilia related functional limitations at 12 months as assessed by HAL
timeFrame: 12 months
measure: Anxiety at 1 week as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety Short Form v1.0
timeFrame: 1 week
measure: Anxiety at 3 months as assessed by PROMIS-Anxiety Short Form v1.0
timeFrame: 3 months
measure: Anxiety at 6 months as assessed by PROMIS-Anxiety Short Form v1.0
timeFrame: 6 months
measure: Anxiety at 12 months as assessed by PROMIS-Anxiety Short Form v1.0
timeFrame: 12 months
measure: Depression at 1 week as assessed by PROMIS-Depression Short Form v1.0
timeFrame: 1 week
measure: Depression at 3 months as assessed by PROMIS-Depression Short Form v1.0
timeFrame: 3 months
measure: Depression at 6 months as assessed by PROMIS-Depression Short Form v1.0
timeFrame: 6 months
measure: Depression at 12 months as assessed by PROMIS-Depression Short Form v1.0
timeFrame: 12 months
measure: Pain Catastrophizing at 1 week as assessed by Coping Strategies Questionnaire (CSQ) Catastrophizing Subscale
timeFrame: 1 week
measure: Pain Catastrophizing at 3 months as assessed by CSQ Catastrophizing Subscale
timeFrame: 3 months
measure: Pain Catastrophizing at 6 months as assessed by CSQ Catastrophizing Subscale
timeFrame: 6 months
measure: Pain Catastrophizing at 12 months as assessed by CSQ Catastrophizing Subscale
timeFrame: 12 months
measure: Illness Perception (Personal Control) at 1 week as assessed by Revised Illness Perception Questionnaire (IPQ-R)
timeFrame: 1 week
measure: Illness Perception (Emotional Representation) at 1 week as assessed by IPQ-R
timeFrame: 1 week
measure: Illness Perception (Personal Control) at 3 months as assessed by IPQ-R
timeFrame: 3 months
measure: Illness Perception (Emotional Representation) at 3 months as assessed by IPQ-R
timeFrame: 3 months
measure: Illness Perception (Personal Control) at 6 months as assessed by IPQ-R
timeFrame: 6 months
measure: Illness Perception (Emotional Representation) at 6 months as assessed by IPQ-R
timeFrame: 6 months
measure: Illness Perception (Personal Control) at 12 months as assessed by IPQ-R
timeFrame: 12 months
measure: Illness Perception (Emotional Representation) at 12 months as assessed by IPQ-R
timeFrame: 12 months
measure: Number of joint bleeds in the previous month, at 1 week
timeFrame: 1 week
measure: Number of joint bleeds in the previous month, at 3 months
timeFrame: 3 months
measure: Number of joint bleeds in the previous month, at 6 months
timeFrame: 6 months
measure: Number of joint bleeds in the previous month, at 12 months
timeFrame: 12 months
measure: Analgesic intake in the previous month, at 1 week
timeFrame: 1 week
measure: Analgesic intake in the previous month, at 3 months
timeFrame: 3 months
measure: Analgesic intake in the previous month, at 6 months
timeFrame: 6 months
measure: Analgesic intake in the previous month, at 12 months
timeFrame: 12 months
measure: Replacement factor (VIII/IX) consumption in the previous month, at 1week
timeFrame: 1 week
measure: Replacement factor (VIII/IX) consumption in the previous month, at 3 months
timeFrame: 3 months
measure: Replacement factor (VIII/IX) consumption in the previous month, at 6 months
timeFrame: 6 months
measure: Replacement factor (VIII/IX) consumption in the previous month, at 12 months
timeFrame: 12 months
measure: Pettersson Score at 3 months
timeFrame: 3 months
measure: Pettersson Score at 12 months
timeFrame: 12 months
measure: Gilbert Score at 3 months
timeFrame: 3 months
measure: Gilbert Score at 12 months
timeFrame: 12 months
measure: IL-6 Cytokine at 3 months
timeFrame: 3 months
measure: IL-6 Cytokine at 12 months
timeFrame: 12 months
measure: IL-1β Cytokine at 6 months
timeFrame: 6 months
measure: IL-1β Cytokine at 12 months
timeFrame: 12 months
measure: IL-10 Cytokine at 6 months
timeFrame: 6 months
measure: IL-10 Cytokine at 12 months
timeFrame: 12 months
measure: TNF-α Cytokine at 6 months
timeFrame: 6 months
measure: TNF-α Cytokine at 12 months
timeFrame: 12 months
measure: C Reactive Protein at 6 months
timeFrame: 6 months
measure: C Reactive Protein at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Braga
country: Portugal
facility: Life and Health Sciences Research Institute
Study officials:
affiliation: Life and Health Sciences Research Institute
name: Patrícia R Pinto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pinto PR, Paredes AC, Costa P, Carvalho M, Lopes M, Fernandes S, Pedras S, Almeida A. Effectiveness of two psychological interventions for pain management, emotional regulation and promotion of quality of life among adult Portuguese men with haemophilia (PSY-HaEMOPEQ): study protocol for a single-centre prospective randomised controlled trial. BMJ Open. 2017 Sep 3;7(9):e016973. doi: 10.1136/bmjopen-2017-016973.