Psychological Treatment of Depression in Women With Fibromyalgia
Condition: Fibromyalgia; Depressive Symptoms
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Depression
Study type: Interventional

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.
    

Intervention name(s): Cognitive Behavioral Therapy; Personal Construct Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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 intervention name(s): CBT; PCT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depressive symptoms; Fibromyalgia; Cognitive Behavioral Therapy; Personal Constructs Therapy; Differential Efficacy