Clinical trial NCT02711020: Psychological Treatment of Depression in Women With Fibromyalgia
Official title: Psychological Treatment of Depression in Women With Fibromyalgia: Differential Efficacy and Factors Predictive of Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Depressive Symptoms
Keywords: Depressive symptoms
Fibromyalgia
Cognitive Behavioral Therapy
Personal Constructs Therapy
Differential Efficacy
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: Universidad Nacional de Educación a Distancia
name: University of Hertfordshire
name: University of Memphis
name: Arborétum
First posted: 2016-03-17
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Change from Baseline in the Hospital Anxiety and Depression Scale at the end of therapy and 6-month follow-up.
timeFrame: End of Therapy (18-30 weeks) and 6-month follow-up (42-54 weeks)
Secondary outcomes:
measure: Change from baseline in the Hamilton-Depression Rating Scale at the end of therapy and 6-month follow-up.
timeFrame: End of Therapy (18-30 weeks) and 6-month follow-up (42-54 weeks)
measure: Change from baseline in the Fibromyalgia Impact Questionnaire at the end of therapy and 6-month follow-up.
timeFrame: End of Therapy (18-30 weeks) and 6-month follow-up (42-54 weeks)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Centro de Atención Primaria Les Hortes
city: Barcelona
country: Spain
facility: Centro de Atención Primaria La Guineueta
city: Barcelona
country: Spain
facility: Centro de Salud Mental de Nou Barris Nord
city: Madrid
country: Spain
facility: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Study officials:
affiliation: University of Barcelona
name: Guillem Feixas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paz C, Aguilera M, Salla M, Compan V, Medina JC, Bados A, Garcia-Grau E, Castel A, Canete Crespillo J, Montesano A, Medeiros-Ferreira L, Feixas G. Personal Construct Therapy vs Cognitive Behavioral Therapy in the Treatment of Depression in Women with Fibromyalgia: Study Protocol for a Multicenter Randomized Controlled Trial. Neuropsychiatr Dis Treat. 2020 Jan 24;16:301-311. doi: 10.2147/NDT.S235161. eCollection 2020.