Testing Interventions for Patients With Fibromyalgia and Depression

NCT03207828 | Unknown

• 1 other identifier: FONIS REGULAR 2017_305
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Depression

Keywords

Behavioral activation

Outcome Measures

Primary Outcomes (1)

• Changes in depressive symptoms severity

  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.

  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.

Secondary Outcomes (6)

• Changes in pain intensity

  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.

• Changes in physical functioning and fibromyalgia symptoms severity.

  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.

• Changes in pain catastrophizing

  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.

• Changes in pain hypervigilance.

  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.

• Changes in self-reported physical health symptoms.

  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.

Other Outcomes (2)

• Changes in pain interference

  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

• Changes in activation

  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

Study Arms (2)

Behavioral activation group

EXPERIMENTAL

This group will receive usual care for fibromyalgia with comorbid major depression plus in-group behavioral activation.

Behavioral: Behavioral activation; Other: Usual care

Usual care

OTHER

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

Interventions

Behavioral activation BEHAVIORAL

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.

Also known as: Brief behavioral activation for depression

Behavioral activation group

Usual care OTHER

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.

Behavioral activation group; Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Red Salud UC Christus

Santiago, Macul, Chile

RECRUITING

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MeSH Terms

Conditions

Fibromyalgia; Depression

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Lidia Gómez Pérez, PhD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lidia Gómez Pérez, PhD

CONTACT

(+56 2) 2354; lgomeze@uc.cl

Alvaro Vergés, PhD

CONTACT

(+56 2) 2354; ajverges@gmail.uc.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients with Fibromialgia and mayor depression will be randomized to two treatment conditions.

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 5, 2017
• Study Start: September 9, 2017
• Primary Completion: March 31, 2019
• Study Completion: May 31, 2019
• Last Updated: September 5, 2018

Record last verified: 2018-09

Locations

CL (1)