Effectiveness of Psychological Interventions in Haemophilia
NCT ID: NCT02870452
Last Updated: 2019-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2018-01-09
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Hypnosis
Hypnosis for the prevention and management of pain, emotional regulation and promotion of quality of life in people with Haemophilia
Hypnosis
4 weekly individual sessions of Hypnosis, conducted by a certified psychologist, with the approximate duration of 90 minutes.
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
Cognitive-Behavioral Therapy
4 weekly individual sessions of CBT, conducted by a certified psychologist, with the approximate duration of 90 minutes.
Control Group
No psychological intervention - standard Haemophilia care
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Age of 18 or older
* Ability to write and read
Exclusion Criteria
* Neurological or psychiatric deficits
* Acquired Haemophilia
18 Years
MALE
No
Sponsors
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Hospital Sao Joao
OTHER
University of Minho
OTHER
Responsible Party
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Patrícia Ribeiro Pinto
Post-doctoral fellow
Principal Investigators
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Patrícia R Pinto, PhD
Role: PRINCIPAL_INVESTIGATOR
Life and Health Sciences Research Institute
Locations
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Life and Health Sciences Research Institute
Braga, , Portugal
Countries
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References
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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.
Other Identifiers
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RCT520101.ID1825
Identifier Type: -
Identifier Source: org_study_id
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