FibromyalgiaPCTFORDEPFMNCT02711020
Psychological Treatment of Depression in Women With Fibromyalgia
A study testing Cognitive Behavioral Therapy and Personal Construct Therapy in people with Fibromyalgia and Depressive Symptoms, run by University of Barcelona at 4 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Fibromyalgia, Depressive Symptoms
- What is being tested?
- Cognitive Behavioral Therapy and Personal Construct Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 4 sitesSpain
- Study dates
- 1 Mar 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of fibromyalgia in the health care system
- A score above 7 on the Hospital Anxiety and Depression Scales
Who cannot join
- Bipolar disorders
- Psychotic symptoms
- Substance abuse
- Organic brain dysfunction
- Mental retardation
- Serious suicidal ideation
Show all 9Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Centro de Atención Primaria Les Hortes
Barcelona, 08004
Centro de Atención Primaria La Guineueta
Barcelona, 08042
Centro de Salud Mental de Nou Barris Nord
Barcelona, 08042
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Madrid, 28040
About this study
Official title: Psychological Treatment of Depression in Women With Fibromyalgia: Differential Efficacy and Factors Predictive of Outcome
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.
Read the 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.
- Conditions
- Fibromyalgia, Depressive Symptoms
- Being tested
- Cognitive Behavioral Therapy, Personal Construct Therapy
- Keywords
- Depressive symptoms, Fibromyalgia, Cognitive Behavioral Therapy, Personal Constructs Therapy, Differential Efficacy
- Medical subject headings
- Fibromyalgia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Also called CBT
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 TherapyBehavioural
Also called PCT
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Active comparator | Cognitive Behavioral Therapy delivered in individual format. Receives: Behavioral: Cognitive Behavioral Therapy |
| Personal Construct Therapy | Experimental | Personal Constructs Therapy delivered in individual format. Receives: Behavioral: Personal Construct Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of Therapy (18-30 weeks) and 6-month follow-up (42-54 weeks)
Secondary outcomes (2)
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.
Measured: End of Therapy (18-30 weeks) and 6-month follow-up (42-54 weeks)
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.
Measured: End of Therapy (18-30 weeks) and 6-month follow-up (42-54 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study start1 Mar 2016
- Primary completion8 Apr 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Nacional de Educación a Distancia, University of Hertfordshire, University of Memphis, Arborétum
- Responsible party
- Principal investigator, Dr. Guillem Feixas, University of Barcelona
- Investigators
- Guillem Feixas, Ph.D., Principal investigator, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711020
- Sponsor's protocol ID
- fibro2016
- Other IDs
- PSI2014-57957-R
- Acronym
- PCTFORDEPFM
- Status last verified
- Mar 2020
- First submitted
- 14 Mar 2016
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32021219
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Treatment of Depression in Women With Fibromyalgia: Differential Efficacy and Factors Predictive of Outcome
- ClinicalTrials.gov ID
- NCT02711020
- Acronym / sponsor ID
- PCTFORDEPFM / fibro2016
- Conditions
- Fibromyalgia, Depressive Symptoms
- Keywords
- Depressive symptoms, Fibromyalgia, Cognitive Behavioral Therapy, Personal Constructs Therapy, Differential Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Collaborators
- Universidad Nacional de Educación a Distancia, University of Hertfordshire, University of Memphis, Arborétum
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 8 Apr 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 17 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Active comparator | Behavioral: Cognitive Behavioral TherapyCognitive Behavioral Therapy delivered in individual format. |
| Personal Construct Therapy | Experimental | Behavioral: Personal Construct TherapyPersonal Constructs Therapy delivered in individual format. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of fibromyalgia in the health care system
- A score above 7 on the Hospital Anxiety and Depression Scales
Key exclusion criteria (9 listed)
- Bipolar disorders
- Psychotic symptoms
- Substance abuse
- Organic brain dysfunction
- Mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyAlso: CBTPatients 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. | Behavioural | Cognitive Behavioral Therapy |
| Personal Construct TherapyAlso: PCTPatients 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. | Behavioural | Personal Construct Therapy |
Primary outcome
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.
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Derived from this study: PubMed 32021219Paz 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.
- Individual participant dataSharing planned: No
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillem Feixas, Ph.D. principal investigator
University of Barcelona
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy and Personal Construct Therapy in people with Fibromyalgia and Depressive Symptoms, run by University of Barcelona at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02711020, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.