Psychological Treatment of Depression in Women With Fibromyalgia (PCTFORDEPFM)
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|ClinicalTrials.gov Identifier: NCT02711020|
Recruitment Status : Recruiting
First Posted : March 17, 2016
Last Update Posted : May 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia Depressive Symptoms||Behavioral: Cognitive Behavioral Therapy Behavioral: Personal Construct Therapy||Not Applicable|
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.
|Study Type :||Interventional|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Psychological Treatment of Depression in Women With Fibromyalgia: Differential Efficacy and Factors Predictive of Outcome|
|Actual Study Start Date :||March 1, 2016|
|Estimated Primary Completion Date :||May 18, 2018|
|Estimated Study Completion Date :||December 2018|
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
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02711020
|Contact: Guillem Feixas, Ph.D.||+34 firstname.lastname@example.org|
|Centro de Atención Primaria Les Hortes||Recruiting|
|Barcelona, Spain, 08004|
|Contact: Lucía García +34 933249100 email@example.com|
|Centro de Atención Primaria La Guineueta||Recruiting|
|Barcelona, Spain, 08042|
|Contact: Sílvia Oriach +34 932749534 firstname.lastname@example.org|
|Centro de Salud Mental de Nou Barris Nord||Recruiting|
|Barcelona, Spain, 08042|
|Contact: Leticia Medeiros, MD +34 933538422 email@example.com|
|Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz||Recruiting|
|Madrid, Spain, 28040|
|Contact: Marta Segura, MSc +34 915504800 firstname.lastname@example.org|
|Principal Investigator:||Guillem Feixas, Ph.D.||University of Barcelona|