Psychological Treatment of Depression in Women With Fibromyalgia

Fibromyalgia Clinical Trial

— PCTFORDEPFM  

Official title:

Psychological Treatment of Depression in Women With Fibromyalgia: Differential Efficacy and Factors Predictive of Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02711020
• Other study ID #: fibro2016
• Secondary ID: PSI2014-57957-R
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: December 2019

Study information

• Verified date: March 2020
• Source: University of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2019
• Est. primary completion date: April 8, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Centro de Atención Primaria La Guineueta	Barcelona
Spain	Centro de Atención Primaria Les Hortes	Barcelona
Spain	Centro de Salud Mental de Nou Barris Nord	Barcelona
Spain	Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz	Madrid

Sponsors (5)

Lead Sponsor	Collaborator
University of Barcelona	Arborétum, Universidad Nacional de Educación a Distancia, University of Hertfordshire, University of Memphis

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the Hospital Anxiety and Depression Scale at the end of therapy and 6-month follow-up.	To assess change in the severity of depressive symptoms with a self-report instrument.	End of Therapy (18-30 weeks) and 6-month follow-up (42-54 weeks)
Secondary	Change from baseline in the Hamilton-Depression Rating Scale at the end of therapy and 6-month follow-up.	To assess change in the severity of depressive symptoms with a clinician-administered instrument.	End of Therapy (18-30 weeks) and 6-month follow-up (42-54 weeks)
Secondary	Change from baseline in the Fibromyalgia Impact Questionnaire at the end of therapy and 6-month follow-up.	To assess change in the impact of fibromyalgia on functional capacity and quality of life.	End of Therapy (18-30 weeks) and 6-month follow-up (42-54 weeks)