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Trial record 39 of 107 for:    fibromyalgia | Recruiting, Not yet recruiting, Available Studies | Interventional Studies

Testing Interventions for Patients With Fibromyalgia and Depression

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ClinicalTrials.gov Identifier: NCT03207828
Recruitment Status : Recruiting
First Posted : July 5, 2017
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
Lydia Gomez Perez, Pontificia Universidad Catolica de Chile

Brief Summary:
Chronic pain is a major health problem. It causes high economic and social costs around the world and severely impairs the quality of life of those who suffer from it. Chronic pain and major depression frequently co-occur. Patients with both conditions have a worse prognosis and higher disability, and their treatment options are scarce. Behavioral activation (BA) may be an especially useful intervention for these patients. This intervention targets mechanisms of action that seem to be common to both disorders. In spite of this, the efficacy of this intervention has not been yet examined in people with both conditions. Therefore, the purpose of the present study is to examine the efficacy of BA compared to usual care among Chilean women with fibromyalgia and mayor depression (N = 90). Women will be randomized to an experimental arm (n = 45) who will receive usual care (UC) for fibromyalgia with comorbid depression plus BA; and a comparison arm, who will receive only UC for fibromyalgia with comorbid depression (n =45). Primary and secondary outcomes will be assessed before, during, and after the intervention, as well as at a three month follow-up. The investigators expect to find that, after treatment, the group receiving BA will experience higher statistical and clinical significant reductions in depressive symptom severity (primary outcome), as well as in their levels of some pain-related variables (namely pain intensity, fibromyalgia impact, pain-related anxiety, catastrophism, and physical health symptoms severity). In addition, the percentage of women in remission from the diagnosis of depression (as well as the percentage of women responding to treatment) will be greater in the experimental arm than in the comparison arm. Also, the percentage of women who show a clinically significant reduction in pain intensity (decreases greater than two units in the pain intensity scale) will be greater in the experimental arm than in the comparison arm. Finally, the investigators hypothesize that the decrease observed in the pain-related variables will be mediated by the decrease observed in depressive symptoms severity. Regarding the outcomes assessed at a three months follow-up, the investigators expect to find that the differences found after treatment between the two arms will be maintained at follow-up. In order to test our hypothesis, Hierarchical Linear Models (HLM) and Cochran-Mantel-Haenszel tests will be performed. The results of these study might contribute to facilitate the integrated treatment of fibromyalgia and depression, and to reduce the burden on the health system due to the lack of effective therapeutic strategies to treat these comorbidity.

Condition or disease Intervention/treatment Phase
Fibromyalgia Depression Behavioral: Behavioral activation Other: Usual care Not Applicable

  Show Detailed Description

Study Type : Interventional
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients with Fibromialgia and mayor depression will be randomized to two treatment conditions.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participants: blind to hypothesis and blind regarding which conditions they have been assigned. To mask the condition, participants of both arms will receive the experimental intervention. Control participants will need to wait to receive the intervention. Control participants will know that the time waiting to be attended can vary among participants (and that even participants in the experimental group may have to wait). They also would know that (while waiting to be intervened) participants will need to attend to a series of assessments, and that five month is the longest period they will need to wait. Care providers: blind to all the study aspects but not to its aims. Investigators: blind to the subject treatment assignment and the outcomes. Outcomes assessors: blind to all aspects. Interventionist: blind to hypothesis and outcomes. Research assistant: blind to everything but not to aims and implementation.
Primary Purpose: Treatment
Official Title: "Eficacia de la Terapia de activación Conductual Para Pacientes Con Dolor crónico: Ensayo clínico Randomizado"
Actual Study Start Date : September 9, 2017
Estimated Primary Completion Date : July 27, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: Behavioral activation group
This group will receive usual care for fibromyalgia with comorbid major depression plus in-group behavioral activation.
Behavioral: Behavioral activation
The Brief Behavioral Activation Treatment for Depression (Lejuez, Hopko, Acierno, Daughters, & Pagoto, 2011; Lejuez, Hopko, LePage, Hopko, and McNeil; 2001) will be used. It aims are (1) to increase engagement with activities associated with pleasure or mastery experiences; (2) decrease engagement with activities that maintain or increase the risk of depression; (3) and remove the barriers that limit the access to gratification. The sessions of therapy are well structured and described in its manual. The protocol was originally designed to be applied individually. However, for the present research, it will be adjusted to be applied in group sessions (5-8 participants). Materials will be also adjusted to be use with Chilean population. Treatment core aspects will not be altered. The treatment will last 10 sessions over two months. Two psychologist trained in behavioral activation will lead the sessions.
Other Name: Brief behavioral activation for depression

Other: Usual care
Participants will be attended by a Medical Doctor that has a high level of expertise in fibromyalgia (rheumatologist or chronic pain specialist) at the Red Salud Christus, the most important private medical care network in Chile. In this clinic the protocol for the treatment of fibromyalgia includes administering pregabalin or gabapentin and pain killer (avoiding opioids). I addition, muscle relaxant such as cyclobenzaprine can be also administered to improve sleep quality. In a high proportion of cases (around 42%), antidepressant with analgesic properties, namely duloxetine, is prescribed. In addition, usual care includes derivation to psychiatrist if needed.

Usual care

This group of participants will only receive usual care for fibromyalgia with comorbid depression.

Participants will be attended by a Medical Doctor that has a high level of expertise in fibromyalgia (rheumatologist or chronic pain specialist) of the Red Salud Christus, the most important private medical care network in Chile. In this clinic treatment of fibromyalgia includes administering pregabalin and pain killers (avoiding opioids). I addition, muscle relaxant such as cyclobenzaprine can be also administered. In a high proportion of cases (around 42%), antidepressant with analgesic properties, namely duloxetine, is prescribed. In addition, usual care includes derivation to psychiatrist if needed.

Other: Usual care
Participants will be attended by a Medical Doctor that has a high level of expertise in fibromyalgia (rheumatologist or chronic pain specialist) at the Red Salud Christus, the most important private medical care network in Chile. In this clinic the protocol for the treatment of fibromyalgia includes administering pregabalin or gabapentin and pain killer (avoiding opioids). I addition, muscle relaxant such as cyclobenzaprine can be also administered to improve sleep quality. In a high proportion of cases (around 42%), antidepressant with analgesic properties, namely duloxetine, is prescribed. In addition, usual care includes derivation to psychiatrist if needed.




Primary Outcome Measures :
  1. Changes in depressive symptoms severity [ Time Frame: Depressive symptoms will be assessed four times: at baseline, during treatment (one month after the start of the treatment), immediately after the treatment, and at three month follow up. As such the participant will be assessed during five months. ]

    Patients Health Questionnaire-9 (PHQ-9; Baader et al., 2008). It consists of 9 items evaluating the presence of depressive symptoms in the last two weeks. Its psychometric properties have been examined in Chilean population. It shows a sensitivity of 92% and specificity of 89%. Item response options are: 0 = never, 1 = some days, 2 = more than half the days and 3 = almost every day. Patients can be classified in:

    Major depressive syndrome: presence of 5 or more of the 9 depressive symptoms with an index of severity of more than half of the days, and one of the symptoms is mood depressive or anhedonia.

    Other depressive syndrome: presence of 2, 3 or 4 depressive symptoms for more of half the days and one of the symptoms is depressive mood or anhedonia.

    Positive depressive symptoms: presence of at least one or two of the symptoms depressive, but fails to complete the above criteria.

    Negative depressive symptoms: does not present any diagnostic criteria more than half of the days.



Secondary Outcome Measures :
  1. Changes in pain intensity [ Time Frame: Pain intensity will be assessed four times: at baseline, during treatment (one month after the start of the treatment), immediately after the treatment, and at three month follow up. As such the participant will be assessed during five months. ]
    The Composed Pain Intensity Index (Jensen, Turner, Romano, & Fisher, 1999) will be used to assess pain intensity. According to the recommendations of Jensen et al. (1999), patients will be asked to rate their lowest, medium, and strongest pain during the previous week, as well as their current pain, on a scale ranging from 0 (not at all) to 10 (extremely painful). The mean of these four scores will be calculated to obtain the average pain intensity. These scale have shown to be valid and reliable and to be sensible to treatment effects in several studies (Williamson & Hoggart, 2005).

  2. Changes in physical functioning and fibromyalgia symptoms severity. [ Time Frame: The FIQ-R will be completed four times: at baseline, during treatment (one month after the start of the treatment), immediately after the treatment, and at three month follow up. ]
    The Fibromyalgia Impact Questionnaire Revised (FIQ-R; Bennett et al., 2009) will be used. It comprises 21 items with responses options ranging from 0 to 10, which are organized in three subscales: The functioning scale (9 items), the symptoms scale (10 items), and the general impact subscale (2 items). The functioning scale assess difficulties to performed several activities during last week. The symptoms scale includes items assessing the severity of ten symptoms that frequently affect patients with fibromyalgia (e. g., memory problems, body stiffness, etc). Finally, two items assesses the general impact of the fibromyalgia.

  3. Changes in pain catastrophizing [ Time Frame: The PCS will be completed four times: at baseline, during treatment (one month after the start of the treatment), immediately after the treatment, and at three month follow up. ]
    Pain Catastrophizing Scale (PCS; Sullivan, Bishop, & Pivik; 1995; García-Campayo, Rodero, Alda, Sobradiel, Montero, et al., 2008). The PCS is one of the most frequently employed scales to assess pain catastrophizing. It comprises 13 items regarding catastrophic pain-related thoughts and emotions that are organized in three subscales: rumination, magnification, and helplessness. Each item has five response options going from 0 Nothing to 4 All the time. The validity and reliability of the PCS has been boadly described in clinical and not clinical samples. The Spanish Scale has properties similar to the original one (García-Campayo et al., 2008).

  4. Changes in pain hypervigilance. [ Time Frame: The PVAQ will be completed four times: at baseline, during treatment (one month after the start of the treatment), immediately after the treatment, and at three month follow up. ]
    The Spanish version of the Pain Vigilance and Awareness Questionnaire (PVAQ, Esteve et al., 2014) will be used to assess pain related anxiety, specifically its cognitive aspects (namely pain hypervigilance). It comprises nine items organized in two subscales: Active vigilance and active awareness. This questionnaire excellent internal consistency (Cronbach alpha values between .82 and .92) and has proved to be valid.

  5. Changes in self-reported physical health symptoms. [ Time Frame: The PHQ-15 will be completed four times: at baseline, during treatment (one month after the start of the treatment), immediately after the treatment, and at three month follow up. ]
    Patients Health Questionnaire (PHQ-15; Ros-Moltalbán, Comas-Vives, & García-García, 2010) will be used to assess physical health symptoms. It comprises 15 items inquiring about somatic symptoms, which account for more than 90% of the symptoms reported in outpatient settings. Respondents rate the severity of each symptom on a 3-point scale (i.e., 0=Not bothered at all, 1=Bothered a little, 2 = Bothered a lot). The PHQ-15 enables classification of participants into four categories according to the reported severity of their symptoms: minimal (scores = 0-4), low (scores = 5-9), medium (scores = 10-14), and high (scores = 15-30). The PHQ-15 has excellent internal reliability and adequate convergent validity. It has shown to be useful to assess somatic complains in speaking Spanish sample.

  6. Changes in environmental reward [ Time Frame: The RPI will be completed four times: at baseline, during treatment (one month after the start of the treatment), immediately after the treatment, and at three month follow up. ]
    The Reward Probability Index, RPI (Carvalho, Gawrysiak, Hellmuth, McNulty, Magidson, Lejuez & Hopko, 2011). It comprises 20 ítems which assess access to environmental reward and are organized in two factors: Reward Probability and Environmental Suppressors) with strong internal consistency (α=.90). The instruments have shown adequate convergent and discriminant validity (Carvalho et al., 2011).


Other Outcome Measures:
  1. Changes in pain interference [ Time Frame: Pain interference will be assessed four times: at baseline, during treatment (one month after the start of the treatment), immediately after the treatment, and at three month follow up ]
    Pain interference will be assessed with the Pain Interference scale of the Spanish version of the Brief Pain Inventory (Ares et al., 2014). This scale comprises seven items each assessing level of interference with function caused by pain in a specific area of life (general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life) in a rating scale going from 0 (no interference) to 10 (complete interference). This scale has shown to present adequate psychometric properties.

  2. Changes in activation [ Time Frame: Activation will be assessed four times: at baseline, during treatment (one month after the start of the treatment), immediately after the treatment, and at three month follow up ]
    Activation will be assessed with the Activation subscale of the Behavioral Activation for Depression Scale (BADS, Barraca, Pérez-Álvarez, & Bleda, 2011). The BADS (Kanter, Mulick, Busch, Berlin, & Martell, 2007) is an instrument aimed at measure changes in avoidance and activation over the course of the BA therapy. In a recent study conducted with Latino participants with depression, a behavioral activation intervention was found to produce higher decreases in depressive symptoms than supporting counselling, but also increased activation and environmental reward (Collado, Calderón, MacPherson, & Lejuez, 2017). The Cronbach alpha for the Activation subscale is .81.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Being 18 years old or older
  2. Understanding Spanish
  3. Meeting the diagnostic criteria for fibromyalgia according to the Fibromyalgia Survey Questionnaire (FSQ)
  4. Have a primary diagnosis of major depression according to the MINI International Neuropsychiatric Interview (MINI).
  5. Being receiving usual care for fibromyalgia and depression in the Medical Center San Joaquín (Red Salud UC Christus, Santiago Chile).
  6. Being under treatment with duloxetine.

Exclusion criteria:

  1. Having past or present history of psychosis, bipolar disorder, or substance use disorder
  2. Presenting risk of suicide according to the suicide module of the MINI
  3. Presenting a lower score than the cut-off point in the Minimental Cognitive Examination
  4. Being participating simultaneously in another therapy for the depression or pain
  5. Being treated with antidepressants other than duloxetine
  6. Being diagnosed with Rheumatoid arthritis or other connective tissue diseases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207828


Contacts
Contact: Lidia Gómez Pérez, PhD (+56 2) 2354 ext 4850 lgomeze@uc.cl
Contact: Alvaro Vergés, PhD (+56 2) 2354 ext 7066 ajverges@gmail.uc.cl

Locations
Chile
Red Salud UC Christus Recruiting
Santiago, Chile, Macul
Contact: Josefina Durán, MA       jgduran@uc.cl   
Contact: Matías González, PhD       magonza@med.puc.cl   
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
Principal Investigator: Lidia Gómez Pérez, PhD Pontificia Universidad Catolica de Chile

Publications:
Baader T, Molina JL, Venezian S, Rojas C, Farías R, Fierro-Freixenet C,.. & Mundt C. Validación y utilidad de la encuesta PHQ-9 (Patient Health Questionnaire) en el diagnóstico de depresión en pacientes usuarios de atención primaria en Chile. Rev Chil Neuro-psiquiatr [internet], 2012 Mar [cited 2017 Jul 5]; 50(1): 10-22. Avaliable from: http://www.scielo.cl/scielo.php?pid=S0717-92272012000100002&script=sci_arttext
Bianchi J, Henao A. Activación conductual y depresión: Conceptualización, evidencia y aplicaciones en Iberoamérica. Ter Psicolo [internet] 2015 May 12 [cited 2017 Jul 5]; 33(2): 69-80. Available from: http://www.scielo.cl/pdf/terpsicol/v33n2/art02.pdf
Gawrysiak M, Nicholas C, Hopko DR. Behavioral activation for moderately depressed university students: Randomized controlled trial. J Couns Psychol [internet]. 2009 Jul; 56(3): 468. Available From: http://dx.doi.org/10.1037/a0016383
González-Hernández J, Aguilar L, Oporto S, Araneda L, Vásquez M, Von Bernhardi R. Normalización del "Mini-Mental State Examination" según edad y educación, para la población de Santiago de Chile. Rev. Memoriza [internet] 2009 [cited 2017 Jul 5]; 3:23-34. Available From: http://www.memoriza.com/documentos/revista/2009/minimental2009_3_23-34.pdf
Houghton S, Curran J, Saxon D. An uncontrolled evaluation of group behavioral activation for depression. Behavior and Cog Psych [Internet] 2008 Mar [cited 2017 Jul 5]; 36: 235-39. Available from: https://www.cambridge.org/core/services/aop-cambridge-core/content/view/CF303D2B68B4E01C8BB90BC216073C3B/S1352465808004207a.pdf/an_uncontrolled_evaluation_of_group_behavioural_activation_for_depression.pdf
Lewinsohn PM, Hoberman H, Teri L, Hautzinger M. An integrative theory of depression. In Theoretical Issues in Behavior Therapy, Ed. S. Reiss, R. Bootzin, pp. 331-59. New York: Academic, 1985. http://www.cambridge.org/cl/academic/subjects/medicine/mental-health-psychiatry-and-clinical-psychology/cambridge-textbook-effective-treatments-psychiatry?format=HB&isbn=9780521842280#jXZHiZM5XTIExWXK.97
Lundervold DA, Talley C, Buermann M. Effect of Behavioral Activation Treatment on fibromyalgia-related pain anxiety cognition. Int J Behav Consult Ther [Internet] 2006 [cited 2017 Jul 5]; 2(1):73, 2006. Available from: http://psycnet.apa.org/journals/bct/2/1/73.pdf
Lundervold DA, Talley C, Buermann M. Effect of behavioral activation treatment on chronic fibromyalgia pain: Replication and extension. Int J Behav Consult Ther [Internet] 2008 [cited 2017 Jul 5]; 4(2):146 - 157. Available from: http://psycnet.apa.org/journals/bct/4/2/146.pdf
Encuesta Nacional de Salud Chile. ENS 2009-2010. Tomo V: Resultados. Available from: http://web.minsal.cl/portal/url/item/bcb03d7bc28b64dfe040010165012d23.pdf
Ferrando L, Bobes J, Gilbert J, Soto, M, Soto, O. Mini International Neuropychiatric Interview (M.I.N.I.). Versión en Español 5.0.0. Madrid: Instituto IAP, 2000. Available from: http://www.academia.cat/files/425-7297-DOCUMENT/MinientrevistaNeuropsiquatribaInternacional.pdf
Mazzucchelli T, Kane R, Rees C. Behavioral activation treatments for depression in adults: a meta‐analysis and review. Clin Psych: Science Prac [Internet] 2009 [cited 2017 Jul 05]; 16(4):383-411. Available from: http://onlinelibrary.wiley.com/doi/10.1111/j.1468-2850.2009.01178.x/epdf
Miranda JP, Quezada P, Caballero P, Jiménez L, Morales A, Bilbeny N, Vega JC. Revisión Sistemática: Epidemiología de Dolor Crónico No Oncológico en Chile. Rev El Dolor [Internet] 2013 [cited 2017 Jul 05]; 59: 10-17. Available from: http://www.ached.cl/upfiles/revistas/documentos/53dfbe675a347_original1_59.pdf
Porter JF, Spates CR, Smitham S. Behavioral Activation Group Therapy in Public Mental Health Settings: A Pilot Investigation. Prof Psychol Res Pr [Internet] 2014 [cited 2017 Jul 05]; 35(3): 297 -301. Available from: http://dx.doi.org/10.1037/0735-7028.35.3.297
Quijano LM, Stanley MA, Peterson, NJ, Casado BL, Steinberg EH, Cully, JA, Wilson NL. Healthy Ideas: a depression intervention delivered by community-based case managers serving older adults. J Appl Gerontol [Internet] 2007 [cited 2017 Jul 05];26: 139-56. Available from: journals.sagepub.com/doi/pdf/10.1177/0733464807299354
Ros S, Comas A, García-García M. Validación de la versión española del cuestionario PHQ- 15 para la evaluación de síntomas físicos en pacientes con trastornos de depresión y/o ansiedad: estudio DEPRE-SOMA. Actas esp psiquiatr [Internet] 2010 [cited 2017 Jul 05]; 38(6): 345- 357. Available from: http://www.actasespanolasdepsiquiatria.es/repositorio/11/68/ESP/11-68-ESP-345-357-775023.pdf
Sullivan M, Bishop S, Pivik J. The Pain Catastrophizing Scale: Development and Validation. Psychol Assessment [Internet] 1995 [cited 2017 Jul 05]; 7(4): 524-532. Available from: http://dx.doi.org/10.1037/1040-3590.7.4.524

Responsible Party: Lydia Gomez Perez, Principal Investigator, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT03207828     History of Changes
Other Study ID Numbers: FONIS REGULAR 2017_305
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lydia Gomez Perez, Pontificia Universidad Catolica de Chile:
Behavioral activation

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Cyclobenzaprine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Tranquilizing Agents
Central Nervous System Depressants