University Jaume I
Castellon, Castellón, 12071, Spain
NCT Number: NCT02375061
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Castellon, Castellón, 12071, Spain
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 4 months
The PCS instructions ask participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time. The PCS yields a total score and three subscale scores assessing rumination, magnification and helplessness. The PCS has been shown to have adequate to excellent 6 internal consistency (coefficient alphas: total PCS = 0.87, rumination = 0.87, magnification = 0.66, and helplessness = 0.78).
Time frame: 4 months
This measure analyzes the levels of positive (PA) and negative affect (NA). The instrument consists of 20 items, 10 for each level of affect. Participants rate on a 5-point scale (Not at all - Extremely). The Spanish version has demonstrated high internal consistency (0.89 to 0.91 for PA and NA in women and 0.87 for AP and 0.89 for AN in men) in college students.
Time frame: 4 months
This scale measures positive and negative expectancies about future events. It consists of 20 statements referring to negative expectancies and 10 statements referring to positive expectancies. Participants answer on a 7-point scale (Not at all likely to occur - Extremely likely to occur). Some studies have found an appropriate levels of internal consistency for positive and negative expectancies (α=0.80-0.82 and 0.91, respectively).
Time frame: 4 months
It consists of 10 items that evaluate perceived well-being in different areas (physical, psychological/emotional, occupational functioning, interpersonal functioning, among others)
Time frame: 4 months
OASIS is a brief instrument consisting of 5 items that measure the frequency and severity of anxiety, as well as the level of avoidance and work/school/home and social interference that anxiety produces.
Time frame: 4 months
This is a 12-item scale that evaluates perceived global self-efficacy and three main aspects of it: initiative, persistence and effort. All items are responded to on a 5-point scale, ranging from 1 (never happens to me) to 5 (always happens to me).
Time frame: 4 months
This scale measures positive and negative expectancies about future events. It consists of 20 statements referring to negative expectancies and 10 statements referring to positive expectancies. Participants answer on a 7-point scale (Not at all likely to occur - Extremely likely to occur). Some studies have found an appropriate levels of internal consistency for positive and negative expectancies (α=0.80-0.82 and 0.91, respectively).
Time frame: 4 months
The FIQ-R is a 10-item self-report questionnaire that measures the health status of patients with FMS assessing the interference of FMS in their daily life.
Time frame: Baseline
It is a well validated self-report instrument for the measurement of general psychological distress.
Time frame: Baseline
This questionnaire assess extrinsic and intrinsic motivation to practice the imagery exercise, rated on a 9-point scale ranging from 1 "not at all for this reason" to 9 "completely for this reason". SCM has been correlated withparticipants' frequency of practicing a daily imagery exercise and with self-reported imagery performance, a key aspect in self-applied interventions.
Time frame: Baseline
This scale assesses the neuroticism level of the individual, showing if he is stable or neurotic. This subscale is composed by 12 items of dicotomic response (yes-not). Regarding psychometric properties, studies found an alpha coefficient between 0.73 and 0.82.
Universitat Jaume I
Other
A Positive Psychology Intervention for Fibromyalgia Patients to Promote Physical and Psychological Wellbeing Using Information and Communication Technologies
Acronym: BPS_FM
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