Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 125 for:    "Depressive Disorder" [DISEASE] AND Behavioral | ( Map: Spain )

Psychological Treatment of Depression in Women With Fibromyalgia (PCTFORDEPFM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02711020
Recruitment Status : Active, not recruiting
First Posted : March 17, 2016
Last Update Posted : April 18, 2019
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

Brief Summary:
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 or disease Intervention/treatment Phase
Fibromyalgia Depressive Symptoms Behavioral: Cognitive Behavioral Therapy Behavioral: Personal Construct Therapy Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Psychological Treatment of Depression in Women With Fibromyalgia: Differential Efficacy and Factors Predictive of Outcome
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : April 8, 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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) ]
    To assess change in the severity of depressive symptoms with a self-report instrument.


Secondary Outcome Measures :
  1. 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) ]
    To assess change in the severity of depressive symptoms with a clinician-administered instrument.

  2. 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) ]
    To assess change in the impact of fibromyalgia on functional capacity and quality of life.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02711020


Locations
Layout table for location information
Spain
Centro de Atención Primaria Les Hortes
Barcelona, Spain, 08004
Centro de Atención Primaria La Guineueta
Barcelona, Spain, 08042
Centro de Salud Mental de Nou Barris Nord
Barcelona, Spain, 08042
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Madrid, Spain, 28040
Sponsors and Collaborators
University of Barcelona
Universidad Nacional de Educación a Distancia
University of Hertfordshire
University of Memphis
Arborétum
Investigators
Layout table for investigator information
Principal Investigator: Guillem Feixas, Ph.D. University of Barcelona

Layout table for additonal 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 ( Other Grant/Funding Number: Ministry of Economy and Competitiveness (Spanish Government) )
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Guillem Feixas, University of Barcelona:
Depressive symptoms
Fibromyalgia
Cognitive Behavioral Therapy
Personal Constructs Therapy
Differential Efficacy
Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Depression
Behavioral Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases