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Clinical Trials/NCT02375061
NCT02375061
Completed
Not Applicable

A Positive Psychology Intervention for Fibromyalgia Patients to Promote Physical and Psychological Wellbeing Using Information and Communication Technologies

Universitat Jaume I1 site in 1 country80 target enrollmentOctober 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fibromyalgia
Sponsor
Universitat Jaume I
Enrollment
80
Locations
1
Primary Endpoint
Beck Depression Inventory II
Status
Completed
Last Updated
9 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
June 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universitat Jaume I
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Beck Depression Inventory II

Time Frame: 4 months

This is one of the most widely questionnaires used to evaluate severity of depression in pharmacological and psychotherapy trials. The instrument has good internal consistency (Cronbach's alpha of 0.76 to 0.95) and test-retest reliability of around 0.8. The Spanish version of this instrument has also shown a high internal consistency (Cronbach's alpha of 0.87) for both the general and the clinical population (Cronbach's alpha of 0.89). Summed to obtain the total score, which can be a maximum of 63 points.

Secondary Outcomes

  • Pain Catastrophizing(4 months)
  • Positive and Negative Affect Scale(4 months)
  • General Self-Efficacy scale(4 months)
  • Life Orientation Test(4 months)
  • Quality of Life(4 months)
  • Overall Anxiety Severity and Impairment Scale(4 months)
  • Subjective probability task(4 months)

Study Sites (1)

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