Trial record 9 of 134 for:    fibromyalgia | Open Studies | Interventional Studies

Psychological Treatment of Depression in Women With Fibromyalgia (PCTFORDEPFM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by University of Barcelona
Sponsor:
Collaborators:
Universidad Nacional de Educación a Distancia
University of Hertfordshire
University of Memphis
Arborétum
Information provided by (Responsible Party):
Dr. Guillem Feixas, University of Barcelona
ClinicalTrials.gov Identifier:
NCT02711020
First received: March 14, 2016
Last updated: March 17, 2016
Last verified: March 2016
  Purpose
The purpose of this study is to perform an efficacy study of Personal Construct Therapy, which focuses on the construction of self and others, for women diagnosed with fibromyalgia who have also comorbid depressive symptoms. To that aim, it will be compared with Cognitive Behavioral Therapy, which is an already well-established treatment in this area.

Condition Intervention
Fibromyalgia
Depressive Symptoms
Behavioral: Cognitive Behavioral Therapy
Behavioral: Personal Construct Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Psychological Treatment of Depression in Women With Fibromyalgia: Differential Efficacy and Factors Predictive of Outcome

Resource links provided by NLM:


Further study details as provided by University of Barcelona:

Primary Outcome Measures:
  • Change from Baseline in the Hospital Anxiety and Depression Scale at the end of therapy and 6-month follow-up. [ Time Frame: End of Therapy (18-30 weeks) and 6-month follow-up (42-54 weeks) ] [ Designated as safety issue: Yes ]
    To assess change in the severity of depressive symptoms with a self-report instrument.


Secondary Outcome Measures:
  • Change from baseline in the Hamilton-Depression Rating Scale at the end of therapy and 6-month follow-up. [ Time Frame: End of Therapy (18-30 weeks) and 6-month follow-up (42-54 weeks) ] [ Designated as safety issue: Yes ]
    To assess change in the severity of depressive symptoms with a clinician-administered instrument.

  • Change from baseline in the Fibromyalgia Impact Questionnaire at the end of therapy and 6-month follow-up. [ Time Frame: End of Therapy (18-30 weeks) and 6-month follow-up (42-54 weeks) ] [ Designated as safety issue: Yes ]
    To assess change in the impact of fibromyalgia on functional capacity and quality of life.


Estimated Enrollment: 110
Study Start Date: March 2016
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cognitive Behavioral Therapy
Cognitive Behavioral Therapy delivered in individual format.
Behavioral: Cognitive Behavioral Therapy
Patients assigned to this arm will receive a maximum of 18 1-hour sessions of Cognitive Behavioral Therapy following the intervention techniques included in various group therapy manuals for patients with fibromyalgia, plus up to three 1-hour boost sessions between 3 and 5 months after the end of therapy. Techniques are adapted to individual format in the following modules: (1) Psychoeducation, (2) Relaxation, (3) Behavioral Activation, (4) Cognitive Restructuring, (5) Problem solving, (6) Assertiveness Training, and (7) Relapse Prevention.
Other Name: CBT
Experimental: Personal Construct Therapy
Personal Constructs Therapy delivered in individual format.
Behavioral: Personal Construct Therapy
Patients will receive a maximum of 18 1-hour sessions of Personal Constructs Therapy plus up to three 1-hour boost sessions between 3 and 5 months after the end of therapy. The intervention will follow a protocol designed specifically for this project based on the clinical experience of a previous pilot study. It will consist of 4 stages: (1) Analysis of patient's request, goals setting, identification of the main dilemmas, and other personal meanings relevant for self and others' construction; (2) feedback on the assessment results and problem reframing in terms of a "dilemma" and/or other personal meanings; (3) work on the dilemmas and/or other aspects of the self and others' construction; and (4) end of the therapeutic process outlining personal projects and future perspectives.
Other Name: PCT

Detailed Description:

Fibromyalgia is one of the most demanding health issues nowadays due to the high level of suffering and the deterioration of quality of life it entails. In addition, its high prevalence and the great expenses it implies for social and health care systems are also matter of both public and politic concern.

Previous research has shown that the personal affliction triggered by fibromyalgia is influenced by psychological factors, which have also an effect on the socioeconomic burden of this disease as a consequence. Among these factors, depressive symptoms are highlighted in this study not only because they exacerbate the clinical profile of this type of patients, but also because they decrease their response to treatment, contributing to the chronicity of this disease. In fact, the treatment of depressive symptoms is already one of the therapeutic targets included in the most recommended multicomponent (and multidisciplinary) treatment guidelines for fibromyalgia.

In spite of the growing number of studies supporting the efficacy of psychological therapies for fibromyalgia, many issues need further development. For example, current treatment recommendations for this syndrome suggest that the intervention must be tailored to the psychosocial and functioning profile of patients. However, research is still needed in order to enable the identification of key factors for clinical improvement. Similarly, it is crucial to identify and assess idiosyncratic psychological characteristics that may allow the psychological intervention to be effectively adapted. In addition, an evidence-based description of the mechanisms involved in change at different levels (including psychological and physical ones) has not been developed yet.

The aim of this project is to perform an efficacy study of Personal Construct Therapy (PCT), which focuses on the construction of self and others, for women diagnosed with fibromyalgia who have also comorbid depressive symptoms. It will be compared with Cognitive Behavioral Therapy (CBT), which is a well-established treatment in this area. Both interventions will be performed in individual format. Depressive symptoms will be measured before and after treatments, along with other clinical and wellbeing-related variables. The cognitive indexes derived from the Repertory Grid Technique, such as cognitive conflicts, polarization and self-construction measures, will also be assessed. Moreover, the capacity of all these measures for predicting differential outcomes resulting from both treatments will also be estimated. The relevance of these cognitive indicators for depression and fibromyalgia has already been proven by this research group in previous studies.

It is expected that PCT will be more effective than standard CBT in improving clinical symptoms and wellbeing. Additionally, the identification of patients' cognitive characteristics which may have a differential response to the components of each treatment will allow future adaptation of psychological interventions to the characteristics of patients, which will contribute in turn to the improvement of the existing treatments.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of fibromyalgia in the health care system
  • A score above 7 on the Hospital Anxiety and Depression Scales

Exclusion Criteria:

  • Bipolar disorders
  • Psychotic symptoms
  • Substance abuse
  • Organic brain dysfunction
  • Mental retardation
  • Serious suicidal ideation
  • Receiving psychological treatment (unless it is suspended at the time of inclusion in the study)
  • Inability to communicate in Spanish
  • Substantial visual, hearing or cognitive deficits
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02711020

Contacts
Contact: Guillem Feixas, Ph.D. +34 933125100 gfeixas@ub.edu

Locations
Spain
Centro de Atención Primaria Les Hortes Recruiting
Barcelona, Spain, 08004
Contact: Lucía García    +34 933249100    uaau.eappoblesec@comb.cat   
Centro de Atención Primaria La Guineueta Recruiting
Barcelona, Spain, 08042
Contact: Sílvia Oriach    +34 932749534    soriach.bcn.ics@gencat.cat   
Centro de Salud Mental de Nou Barris Nord Recruiting
Barcelona, Spain, 08042
Contact: Leticia Medeiros, MD    +34 933538422    zazooatpoa@hotmail.com   
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz Recruiting
Madrid, Spain, 28040
Contact: Marta Segura, MSc    +34 915504800    martasv82@gmail.com   
Sponsors and Collaborators
University of Barcelona
Universidad Nacional de Educación a Distancia
University of Hertfordshire
University of Memphis
Arborétum
Investigators
Principal Investigator: Guillem Feixas, Ph.D. University of Barcelona
  More Information

Responsible Party: Dr. Guillem Feixas, Full Professor, University of Barcelona
ClinicalTrials.gov Identifier: NCT02711020     History of Changes
Other Study ID Numbers: fibro2016  PSI2014-57957-R 
Study First Received: March 14, 2016
Last Updated: March 17, 2016
Health Authority: Spain: Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Barcelona:
Depressive symptoms
Fibromyalgia
Cognitive Behavioral Therapy
Personal Constructs Therapy
Differential Efficacy

Additional relevant MeSH terms:
Depression
Fibromyalgia
Myofascial Pain Syndromes
Behavioral Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 28, 2016