Psychological Treatment of Depression in Women With Fibromyalgia
PCTFORDEPFM
2 other identifiers
interventional
110
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2016
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 14, 2016
CompletedFirst Posted
Study publicly available on registry
March 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedMarch 24, 2020
March 1, 2020
3.1 years
March 14, 2016
March 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change from baseline in the Hamilton-Depression Rating Scale at the end of therapy and 6-month follow-up.
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.
End of Therapy (18-30 weeks) and 6-month follow-up (42-54 weeks)
Study Arms (2)
Cognitive Behavioral Therapy
ACTIVE COMPARATORCognitive Behavioral Therapy delivered in individual format.
Personal Construct Therapy
EXPERIMENTALPersonal Constructs Therapy delivered in individual format.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Diagnosis of fibromyalgia in the health care system
- A score above 7 on the Hospital Anxiety and Depression Scales
You may not qualify if:
- Bipolar disorders
- Psychotic symptoms
- Substance abuse
- Organic brain dysfunction
- Mental retardation
- Serious suicidal ideation
- Inability to communicate in Spanish
- Substantial visual, hearing or cognitive deficits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Barcelonalead
- Universidad Nacional de Educación a Distanciacollaborator
- University of Hertfordshirecollaborator
- University of Memphiscollaborator
- Arborétumcollaborator
Study Sites (4)
Centro de Atención Primaria Les Hortes
Barcelona, 08004, Spain
Centro de Atención Primaria La Guineueta
Barcelona, 08042, Spain
Centro de Salud Mental de Nou Barris Nord
Barcelona, 08042, Spain
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Madrid, 28040, Spain
Related Publications (1)
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.
PMID: 32021219DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guillem Feixas, Ph.D.
University of Barcelona
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor
Study Record Dates
First Submitted
March 14, 2016
First Posted
March 17, 2016
Study Start
March 1, 2016
Primary Completion
April 8, 2019
Study Completion
December 1, 2019
Last Updated
March 24, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share