NCT02870452

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 9, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

12 months

First QC Date

August 9, 2016

Last Update Submit

March 25, 2019

Conditions

Haemophilia

Keywords

HaemophiliaRCTPainHemarthrosisHypnosisCognitive-Behavioral TherapyQuality of LifeDistressCytokines

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (54)

  • 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

  • +49 more secondary outcomes

Study Arms (3)

Hypnosis

EXPERIMENTAL

Hypnosis for the prevention and management of pain, emotional regulation and promotion of quality of life in people with Haemophilia

Behavioral: Hypnosis

Cognitive-Behavioral Therapy

EXPERIMENTAL

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

Control Group

NO INTERVENTION

No psychological intervention - standard Haemophilia care

Interventions

HypnosisBEHAVIORAL

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

Hypnosis
Cognitive-Behavioral TherapyBEHAVIORAL

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

Cognitive-Behavioral Therapy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Life and Health Sciences Research Institute

Braga, 4710-057, Portugal

Location

Related Publications (1)

  • 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.

    PMID: 28871021DERIVED

MeSH Terms

Conditions

Hemophilia APainHemarthrosis

Interventions

HypnosisCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsJoint DiseasesMusculoskeletal DiseasesHemorrhagePathologic Processes

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and ActivitiesBehavior Therapy

Study Officials

  • PatrĂ­cia R Pinto, PhD

    Life and Health Sciences Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-doctoral fellow

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 17, 2016

Study Start

January 9, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

March 26, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)