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Psychological intervention for women with fibromyalgia and insomnia

Intervention in pain and insomnia in women with fibromyalgia in the postmenopausal period

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9kbgk2
Enrollment
Unknown
Registered
2020-01-29
Start date
2014-05-20
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medical diagnoses of Fibromyalgia

Interventions

The interventions consisted of 10 individual sessions in each phase (Phase A and Phase B) and weekly periodicity. They were conducted with 4 participants, in different phases applied at different tim
in the next forty minutes the proposed theme for the session was worked out
and in the remaining twenty minutes the training of Progressive Muscular Relaxation was performed, as instructed by Vera and Vila (2002). The themes of the sessions were programmed based on Fordyce (1
2) Cost-benefit in health care performance and effects of relaxation training
3) Identification of activities that increase pain
4) Functional analysis of environmental variables (physical conditions) related to pain response
5) Survey of positively reinforcing activities
6) Functional analysis of variables that help in coping with pain
7) Discussion about the pain maintenance cycle, 8-10) Identification of progress and maintenance of therapeutic gains related to the physical environment
and for Phase B, the themes were:1) Pain and interpersonal relationships
2) Empathy
3) Expression of positive feelings in interpersonal relationships
4) Discrimination of feelings
5) Patterns of passive, assertive and aggressive behavior
6) Assertive communication (written activity)
7) Assertive communication (role-playing)
8 to 10) Identification of progress and maintenance of therapeutic gains related to the perfor
Behavioural

Sponsors

Universidade Federal de São Carlos
Lead Sponsor
Centro Universitário Central Paulista
Collaborator

Eligibility

Sex/Gender
Female
Age
35 Years to 60 Years

Inclusion criteria

Inclusion criteria: Medical diagnoses of Fibromyalgia, diagnostic symptoms according to Wolfe criteria et al., (2010), and Insomnia Disorder identified according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, DSM-V-TR (2014) and actigraphy data (Octagonal Basic Motionlogger®, Ambulatory monitoring; Actwath-64®, Phillips Respironics).

Exclusion criteria

Exclusion criteria: The participants could not show other sleep disturbance identified by a health professional (e.g: Obstructive Sleep Apnea Syndrome, Restless Legs Syndrome), being on medication for sleep, or participating in psychotherapy during the period of data collection.

Design outcomes

Primary

MeasureTime frame
This study focused on evaluating the effects of an intervention analytic-behavioral involving two components about pain indicators and sleep in women with FM and insomnia, to know: 1) management of physical environment conditions; and, 2) managing interpersonal relationships. Self-report instruments were used in Initial, Intermediate and final evaluate and follow-up, to assess pain intensity and disability (END / S; FIQ-R; and SF – MPQ), sleep quality (PSQI-Br) and insomnia severity (IGI). Actigraphy was used to measure sleep patterns, considering the 4 participants of study (P1,P2,P3 and P4) For P1 and P3, there is a decrease in the scores of the four instruments, after Phase A and Phase B intervention, with maintenance of these effects in the evaluation of Follow-Up (after 30 days) for P1. For P2, the scores on the instruments (FIQ-R, SF-MPQ, PSQI-Br and IGI) were decreased during the evaluation phases, but the SF-MPQ instrument score increased after phase B, and decreased in the Follow-up evaluation. Finally, P4 presented a considerable reduction of the scores for all the instruments, which was decreasing throughout all evaluation phases, with the result of the overall pain assessment (SF-MPQ), reaching zero in the final evaluation. ;Data showed that the intervention (20 sessions) was effective in improving pain and sleep indicators in all participants. The gains observed in the final assessment were maintained or increased in follow-up measures. However, the results should take into consideration the clinical condition and other variables that may have individually impacted the results.

Secondary

MeasureTime frame
Clinical significance was assessed using the JT method (Jacobson and Truax, 1999), which identifies whether the results attributed to intervention, based on scores of the instruments applied in initial and final evaluations, move between the representative ranges clinical and non-clinical.;Clinical significance, JT method, showed that participant 4 went from the clinical population to the non-clinical, in all the indicators evaluated, participant 3 changed the status to non-clinical in relation to sleep quality (PSQI-Br), and participant 1 changed the status to non-clinical in relation to insomnia severity (IGI). Participant 2 remained in the clinical population for all the indicators evaluated, and none of them were moved from the nonclinical to the clinical range after the intervention.

Countries

Brazil

Contacts

Public ContactLuziane Kirchner

Universidade Católica Dom Bosco

luzianefk@gmail.com+55-067-981902100

Outcome results

None listed

Source: REBEC (via WHO ICTRP)