PSY_HaEMOPEQ: Effectiveness of Psychological Interventions in Haemophilia

Sponsor

University of Minho (Other)

Overall Status

Completed

CT.gov ID

NCT02870452

Collaborator

Hospital Sao Joao (Other)

Enrollment

Location

Arms

11.7

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Haemophilia	Behavioral: Hypnosis Behavioral: Cognitive-Behavioral Therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Jan 9, 2018

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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 [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]
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]