Effectiveness of Psychological Interventions in Haemophilia

Haemophilia Clinical Trial

— PSY_HaEMOPEQ  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02870452
• Other study ID #: RCT520101.ID1825
• Status: Completed
• Phase: N/A
• Start date: January 9, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2019
• Source: University of Minho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Haemophilia
• Hemophilia A

Intervention

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

Locations

Country	Name	City	State
Portugal	Life and Health Sciences Research Institute	Braga

Sponsors (2)

Lead Sponsor	Collaborator
University of Minho	Hospital Sao Joao

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity at 1 week as assessed by Numeric Rating Scale (NRS)		1 week post-intervention
Primary	Pain intensity at 3 months as assessed by NRS		3 months post-intervention
Primary	Pain intensity at 6 months as assessed by NRS		6 months post-intervention
Primary	Pain intensity at 12 months as assessed by NRS		12 months post-intervention
Secondary	Health Related Quality of Life (HRQOL) at 1 week as assessed by A36Hemofilia-Qol		1 week
Secondary	HRQOL at 3 months as assessed by A36Hemofilia-Qol		3 months
Secondary	HRQOL at 6 months as assessed by A36Hemofilia-Qol		6 months
Secondary	HRQOL at 12 months as assessed by A36Hemofilia-Qol		12 months
Secondary	Haemophilia related functional limitations at 1 week as assessed by Haemophilia Activities List (HAL)		1 week
Secondary	Haemophilia related functional limitations at 3 months as assessed by HAL		3 months
Secondary	Haemophilia related functional limitations at 6 months as assessed by HAL		6 months
Secondary	Haemophilia related functional limitations at 12 months as assessed by HAL		12 months
Secondary	Anxiety at 1 week as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety Short Form v1.0		1 week
Secondary	Anxiety at 3 months as assessed by PROMIS-Anxiety Short Form v1.0		3 months
Secondary	Anxiety at 6 months as assessed by PROMIS-Anxiety Short Form v1.0		6 months
Secondary	Anxiety at 12 months as assessed by PROMIS-Anxiety Short Form v1.0		12 months
Secondary	Depression at 1 week as assessed by PROMIS-Depression Short Form v1.0		1 week
Secondary	Depression at 3 months as assessed by PROMIS-Depression Short Form v1.0		3 months
Secondary	Depression at 6 months as assessed by PROMIS-Depression Short Form v1.0		6 months
Secondary	Depression at 12 months as assessed by PROMIS-Depression Short Form v1.0		12 months
Secondary	Pain Catastrophizing at 1 week as assessed by Coping Strategies Questionnaire (CSQ) Catastrophizing Subscale		1 week
Secondary	Pain Catastrophizing at 3 months as assessed by CSQ Catastrophizing Subscale		3 months
Secondary	Pain Catastrophizing at 6 months as assessed by CSQ Catastrophizing Subscale		6 months
Secondary	Pain Catastrophizing at 12 months as assessed by CSQ Catastrophizing Subscale		12 months
Secondary	Illness Perception (Personal Control) at 1 week as assessed by Revised Illness Perception Questionnaire (IPQ-R)		1 week
Secondary	Illness Perception (Emotional Representation) at 1 week as assessed by IPQ-R		1 week
Secondary	Illness Perception (Personal Control) at 3 months as assessed by IPQ-R		3 months
Secondary	Illness Perception (Emotional Representation) at 3 months as assessed by IPQ-R		3 months
Secondary	Illness Perception (Personal Control) at 6 months as assessed by IPQ-R		6 months
Secondary	Illness Perception (Emotional Representation) at 6 months as assessed by IPQ-R		6 months
Secondary	Illness Perception (Personal Control) at 12 months as assessed by IPQ-R		12 months
Secondary	Illness Perception (Emotional Representation) at 12 months as assessed by IPQ-R		12 months
Secondary	Number of joint bleeds in the previous month, at 1 week		1 week
Secondary	Number of joint bleeds in the previous month, at 3 months		3 months
Secondary	Number of joint bleeds in the previous month, at 6 months		6 months
Secondary	Number of joint bleeds in the previous month, at 12 months		12 months
Secondary	Analgesic intake in the previous month, at 1 week		1 week
Secondary	Analgesic intake in the previous month, at 3 months		3 months
Secondary	Analgesic intake in the previous month, at 6 months		6 months
Secondary	Analgesic intake in the previous month, at 12 months		12 months
Secondary	Replacement factor (VIII/IX) consumption in the previous month, at 1week		1 week
Secondary	Replacement factor (VIII/IX) consumption in the previous month, at 3 months		3 months
Secondary	Replacement factor (VIII/IX) consumption in the previous month, at 6 months		6 months
Secondary	Replacement factor (VIII/IX) consumption in the previous month, at 12 months		12 months
Secondary	Pettersson Score at 3 months	Radiologic classification of PWH joint status	3 months
Secondary	Pettersson Score at 12 months	Radiologic classification of PWH joint status	12 months
Secondary	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
Secondary	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
Secondary	IL-6 Cytokine at 3 months		3 months
Secondary	IL-6 Cytokine at 12 months		12 months
Secondary	IL-1ß Cytokine at 6 months		6 months
Secondary	IL-1ß Cytokine at 12 months		12 months
Secondary	IL-10 Cytokine at 6 months		6 months
Secondary	IL-10 Cytokine at 12 months		12 months
Secondary	TNF-a Cytokine at 6 months		6 months
Secondary	TNF-a Cytokine at 12 months		12 months
Secondary	C Reactive Protein at 6 months		6 months
Secondary	C Reactive Protein at 12 months		12 months