Effectiveness of Psychological Interventions in Haemophilia (PSY_HaEMOPEQ)

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

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.

Study Overview

• Status: Completed
• Conditions: Haemophilia
• Intervention / Treatment: Behavioral: Hypnosis; Behavioral: Cognitive-Behavioral Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Braga, Portugal, 4710-057
    • Life and Health Sciences Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypnosis; Hypnosis for the prevention and management of pain, emotional regulation and promotion of quality of life in people with Haemophilia	Behavioral: Hypnosis; 4 weekly individual sessions of Hypnosis, conducted by a certified psychologist, with the approximate duration of 90 minutes.
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	Behavioral: Cognitive-Behavioral Therapy; 4 weekly individual sessions of CBT, conducted by a certified psychologist, with the approximate duration of 90 minutes.
No Intervention: Control Group; No psychological intervention - standard Haemophilia care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
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 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
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
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 (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	Radiologic classification of PWH joint status	3 months
Pettersson Score at 12 months	Radiologic classification of PWH joint status	12 months
Gilbert Score at 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	3 months
Gilbert Score at 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	12 months
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
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
C Reactive Protein at 6 months		6 months
C Reactive Protein at 12 months		12 months

Collaborators and Investigators

• Sponsor: University of Minho
• Collaborators: Hospital Sao Joao

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: August 9, 2016
• First Submitted That Met QC Criteria: August 11, 2016
• First Posted (Estimate): August 17, 2016

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Quality of Life; Pain; Hypnosis; RCT; Cytokines; Cognitive-Behavioral Therapy; Haemophilia; Distress; Hemarthrosis
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Blood Coagulation Disorders; Hemophilia A
• Other Study ID Numbers: RCT520101.ID1825

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No