Psychological Treatment of Depression in Women With Fibromyalgia

NCT02711020 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2020-03-24

No results posted yet for this study

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.

Conditions

  • Fibromyalgia
  • Depressive Symptoms

Interventions

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.

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.

Sponsors & Collaborators

  • Universidad Nacional de Educación a Distancia

    collaborator OTHER
  • University of Hertfordshire

    collaborator OTHER
  • University of Memphis

    collaborator OTHER
  • Arborétum

    collaborator UNKNOWN
  • University of Barcelona

    lead OTHER

Principal Investigators

  • Guillem Feixas, Ph.D. · University of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2019-04-08
Completion
2019-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02711020 on ClinicalTrials.gov