Clinical trial NCT02375061: A Positive Psychology Intervention for Fibromyalgia Patients Using ICT´s
Official title: A Positive Psychology Intervention for Fibromyalgia Patients to Promote Physical and Psychological Wellbeing Using Information and Communication Technologies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Chronic Pain
Keywords: Best Possible Self
Positive Psychology
Optimism
Positive Technologies
Future thinking
Pain Catastrophizing
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is aimed to test the efficacy of a Positive Psychology Intervention (Best Possible Self, BPS) over optimism, future expectancies and positive affect at mid-term, in comparison to a control group, in fibromyalgia patients. The principal hypothesis is that the BPS intervention will enhance significantly the levels of optimism, positive future expectancies and positive affect in comparison to the Control group at short and mid-term.

Detailed description: Previous studies have demonstrated the effects of positive psychological factors in pain adjustment. Specially, optimism has been linked to lower pain sensitivity, better physical functioning, less psychological distress and pain catastrophizing. Until recently, the beneficial effects of optimism on pain have been studied mostly in correlational studies or in experimental interventions in laboratory settings. To address the gap between research and clinical practice, the aim of this study is to test the efficacy of the Best Possible Self intervention (BPS) using Information and Communication Technologies (ICTs) with fibromyalgia patients.

BPS is a guided imagery exercise that requires participants to envision themselves in the future, achieving desired goals in different areas of their lives. This exercise has shown efficacy improving optimism, future expectancies and positive affect compared to a control condition, in general population (Meevissen, Peters \& Alberts, 2011; Sheldon \&Lyubomirsky, 2012; Peters, Flink, Boersma \& Linton, 2010). Taking into account the prior literature, the aim of the present study is to carry out a randomized controlled study in order to replicate the findings about the effects of BPS on optimism, mood and affect in a chronic pain population. The exercise will be applied through a Positive Technology system and the effects will be analyzed during four months. The design employed in this study is similar to the used in other studies (Meevissen et al, 2011; Renner, Schwarz, Peters \& Huibers, 2014; Sheldon \& Lyubomirsky, 2006).

Eligibility criteria: Inclusion Criteria:

* Patients have to fulfill the American College of Rheumatology criteria for primary FMS.
* Sign a consent form stating their willingness to participate

Exclusion Criteria:

* Presence of another severe physical illness
* Presence of severe psychological disorders
* Be currently involved in another psychological treatment

Primary outcomes:
measure: Beck Depression Inventory II
timeFrame: 4 months
Secondary outcomes:
measure: Pain Catastrophizing
timeFrame: 4 months
measure: Positive and Negative Affect Scale
timeFrame: 4 months
measure: Life Orientation Test
timeFrame: 4 months
measure: Quality of Life
timeFrame: 4 months
measure: Overall Anxiety Severity and Impairment Scale
timeFrame: 4 months
measure: General Self-Efficacy scale
timeFrame: 4 months
measure: Subjective probability task
timeFrame: 4 months
Other outcomes:
measure: Fibromyalgia Impact Questionnaire
timeFrame: 4 months
measure: Brief Symptom Inventory
timeFrame: Baseline
measure: Self concordance motivation
timeFrame: Baseline
measure: Eysenck Personality Questionnaire - Revised - Neuroticism
timeFrame: Baseline
Locations:
city: Castellón
country: Spain
facility: University Jaume I
Study officials:
affiliation: Universitat Jaume I
name: Azucena García-Palacios, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meevissen YM, Peters ML, Alberts HJ. Become more optimistic by imagining a best possible self: effects of a two week intervention. J Behav Ther Exp Psychiatry. 2011 Sep;42(3):371-8. doi: 10.1016/j.jbtep.2011.02.012. Epub 2011 Mar 2.
citation: Boselie JJLM, Vancleef LMG, Smeets T, Peters ML. Increasing optimism abolishes pain-induced impairments in executive task performance. Pain. 2014 Feb;155(2):334-340. doi: 10.1016/j.pain.2013.10.014. Epub 2013 Oct 19.
citation: Hanssen MM, Vancleef LM, Vlaeyen JW, Peters ML. More optimism, less pain! The influence of generalized and pain-specific expectations on experienced cold-pressor pain. J Behav Med. 2014 Feb;37(1):47-58. doi: 10.1007/s10865-012-9463-8. Epub 2012 Oct 23.
citation: Hanssen MM, Peters ML, Vlaeyen JWS, Meevissen YMC, Vancleef LMG. Optimism lowers pain: evidence of the causal status and underlying mechanisms. Pain. 2013 Jan;154(1):53-58. doi: 10.1016/j.pain.2012.08.006. Epub 2012 Oct 18.
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citation: Sheldon, K. M., y Lyubomirsky, S. (2006). How to increase and sustain positive emotion: The effects of expressing gratitude and visualizing best possible selves. The Journal of Positive Psychology, 1(2), 73-82.
citation: Esteve-Vives J, Rivera Redondo J, Isabel Salvat Salvat M, de Gracia Blanco M, de Miquel CA. [Proposal for a consensus version of the Fibromyalgia Impact Questionnaire (FIQ) for the Spanish population]. Reumatol Clin. 2007 Jan;3(1):21-4. doi: 10.1016/S1699-258X(07)73594-5. Epub 2008 Nov 13. Spanish.
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