AzTrials
AzTrials

HaemophiliaPSY_HaEMOPEQNCT02870452

Effectiveness of Psychological Interventions in Haemophilia

A study testing Hypnosis and Cognitive-Behavioral Therapy in people with Haemophilia, run by University of Minho at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Haemophilia
What is being tested?
Hypnosis and Cognitive-Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 sitePortugal
Study dates
9 Jan 2018to 31 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Mild pr severe Haemophilia A or B
  • Age of 18 or older
  • Ability to write and read

Who cannot join

  • Other comorbid life threatening diseases, such as cancer
  • Neurological or psychiatric deficits
  • Acquired Haemophilia

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • Life and Health Sciences Research Institute

    Braga, 4710-057

Other trials in Portugal

About this study

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

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.

Read the 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.

Conditions
Haemophilia
Being tested
Hypnosis, Cognitive-Behavioral Therapy
Keywords
Haemophilia, RCT, Pain, Hemarthrosis, Hypnosis, Cognitive-Behavioral Therapy, Quality of Life, Distress, Cytokines
Medical subject headings
Hemophilia A, Pain, Hemarthrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HypnosisBehavioural

    4 weekly individual sessions of Hypnosis, conducted by a certified psychologist, with the approximate duration of 90 minutes.

  • Cognitive-Behavioral TherapyBehavioural

    4 weekly individual sessions of CBT, conducted by a certified psychologist, with the approximate duration of 90 minutes.

Study groups in NCT02870452
Study groupRoleWhat they receive
HypnosisExperimentalHypnosis for the prevention and management of pain, emotional regulation and promotion of quality of life in people with Haemophilia
Receives: Behavioral: Hypnosis
Cognitive-Behavioral TherapyExperimentalCognitive Behavioral Therapy for the prevention and management of pain, emotional regulation and promotion of quality of life in people with Haemophilia
Receives: Behavioral: Cognitive-Behavioral Therapy
Control GroupNo interventionNo psychological intervention - standard Haemophilia care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain intensity at 1 week as assessed by Numeric Rating Scale (NRS)

    Measured: 1 week post-intervention

  2. Pain intensity at 3 months as assessed by NRS

    Measured: 3 months post-intervention

  3. Pain intensity at 6 months as assessed by NRS

    Measured: 6 months post-intervention

  4. Pain intensity at 12 months as assessed by NRS

    Measured: 12 months post-intervention

Secondary outcomes (54)

  1. Health Related Quality of Life (HRQOL) at 1 week as assessed by A36Hemofilia-Qol

    Measured: 1 week

  2. HRQOL at 3 months as assessed by A36Hemofilia-Qol

    Measured: 3 months

  3. HRQOL at 6 months as assessed by A36Hemofilia-Qol

    Measured: 6 months

  4. HRQOL at 12 months as assessed by A36Hemofilia-Qol

    Measured: 12 months

  5. Haemophilia related functional limitations at 1 week as assessed by Haemophilia Activities List (HAL)

    Measured: 1 week

  6. Haemophilia related functional limitations at 3 months as assessed by HAL

    Measured: 3 months

  7. Haemophilia related functional limitations at 6 months as assessed by HAL

    Measured: 6 months

  8. Haemophilia related functional limitations at 12 months as assessed by HAL

    Measured: 12 months

  9. Anxiety at 1 week as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety Short Form v1.0

    Measured: 1 week

  10. Anxiety at 3 months as assessed by PROMIS-Anxiety Short Form v1.0

    Measured: 3 months

  11. Anxiety at 6 months as assessed by PROMIS-Anxiety Short Form v1.0

    Measured: 6 months

  12. Anxiety at 12 months as assessed by PROMIS-Anxiety Short Form v1.0

    Measured: 12 months

  13. Depression at 1 week as assessed by PROMIS-Depression Short Form v1.0

    Measured: 1 week

  14. Depression at 3 months as assessed by PROMIS-Depression Short Form v1.0

    Measured: 3 months

  15. Depression at 6 months as assessed by PROMIS-Depression Short Form v1.0

    Measured: 6 months

  16. Depression at 12 months as assessed by PROMIS-Depression Short Form v1.0

    Measured: 12 months

  17. Pain Catastrophizing at 1 week as assessed by Coping Strategies Questionnaire (CSQ) Catastrophizing Subscale

    Measured: 1 week

  18. Pain Catastrophizing at 3 months as assessed by CSQ Catastrophizing Subscale

    Measured: 3 months

  19. Pain Catastrophizing at 6 months as assessed by CSQ Catastrophizing Subscale

    Measured: 6 months

  20. Pain Catastrophizing at 12 months as assessed by CSQ Catastrophizing Subscale

    Measured: 12 months

  21. Illness Perception (Personal Control) at 1 week as assessed by Revised Illness Perception Questionnaire (IPQ-R)

    Measured: 1 week

  22. Illness Perception (Emotional Representation) at 1 week as assessed by IPQ-R

    Measured: 1 week

  23. Illness Perception (Personal Control) at 3 months as assessed by IPQ-R

    Measured: 3 months

  24. Illness Perception (Emotional Representation) at 3 months as assessed by IPQ-R

    Measured: 3 months

  25. Illness Perception (Personal Control) at 6 months as assessed by IPQ-R

    Measured: 6 months

  26. Illness Perception (Emotional Representation) at 6 months as assessed by IPQ-R

    Measured: 6 months

  27. Illness Perception (Personal Control) at 12 months as assessed by IPQ-R

    Measured: 12 months

  28. Illness Perception (Emotional Representation) at 12 months as assessed by IPQ-R

    Measured: 12 months

  29. Number of joint bleeds in the previous month, at 1 week

    Measured: 1 week

  30. Number of joint bleeds in the previous month, at 3 months

    Measured: 3 months

  31. Number of joint bleeds in the previous month, at 6 months

    Measured: 6 months

  32. Number of joint bleeds in the previous month, at 12 months

    Measured: 12 months

  33. Analgesic intake in the previous month, at 1 week

    Measured: 1 week

  34. Analgesic intake in the previous month, at 3 months

    Measured: 3 months

  35. Analgesic intake in the previous month, at 6 months

    Measured: 6 months

  36. Analgesic intake in the previous month, at 12 months

    Measured: 12 months

  37. Replacement factor (VIII/IX) consumption in the previous month, at 1week

    Measured: 1 week

  38. Replacement factor (VIII/IX) consumption in the previous month, at 3 months

    Measured: 3 months

  39. Replacement factor (VIII/IX) consumption in the previous month, at 6 months

    Measured: 6 months

  40. Replacement factor (VIII/IX) consumption in the previous month, at 12 months

    Measured: 12 months

  41. Pettersson Score at 3 months

    Radiologic classification of PWH joint status

    Measured: 3 months

  42. Pettersson Score at 12 months

    Radiologic classification of PWH joint status

    Measured: 12 months

  43. 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

    Measured: 3 months

  44. 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

    Measured: 12 months

  45. IL-6 Cytokine at 3 months

    Measured: 3 months

  46. IL-6 Cytokine at 12 months

    Measured: 12 months

  47. IL-1β Cytokine at 6 months

    Measured: 6 months

  48. IL-1β Cytokine at 12 months

    Measured: 12 months

  49. IL-10 Cytokine at 6 months

    Measured: 6 months

  50. IL-10 Cytokine at 12 months

    Measured: 12 months

  51. TNF-α Cytokine at 6 months

    Measured: 6 months

  52. TNF-α Cytokine at 12 months

    Measured: 12 months

  53. C Reactive Protein at 6 months

    Measured: 6 months

  54. C Reactive Protein at 12 months

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2016 (estimated)
  2. Study start9 Jan 2018
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02870452
Sponsor's protocol ID
RCT520101.ID1825
Acronym
PSY_HaEMOPEQ
Status last verified
Mar 2019
First submitted
9 Aug 2016
Last updated
26 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 28871021

Questions about this trial

What is this clinical trial studying?

A study testing Hypnosis and Cognitive-Behavioral Therapy in people with Haemophilia, run by University of Minho at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain intensity at 1 week as assessed by Numeric Rating Scale (NRS) (time frame: 1 week post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02870452, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in