Trial record 53 of 116 for:    fibromyalgia | Open Studies | Interventional Studies

A Positive Psychology Intervention for Fibromyalgia Patients Using ICT´s (BPS_FM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Universitat Jaume I
Sponsor:
Information provided by (Responsible Party):
Universitat Jaume I
ClinicalTrials.gov Identifier:
NCT02375061
First received: February 16, 2015
Last updated: March 2, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention
Fibromyalgia
Chronic Pain
Behavioral: e-BPS
Behavioral: Daily Activities

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Positive Psychology Intervention for Fibromyalgia Patients to Promote Physical and Psychological Wellbeing Using Information and Communication Technologies

Resource links provided by NLM:


Further study details as provided by Universitat Jaume I:

Primary Outcome Measures:
  • Subjective Probability Task [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Pain Catastrophizing [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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).

  • Positive and Negative Affect Scale [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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.

  • Life Orientation Test [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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).

  • Beck Depression Inventory II [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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.

  • Quality of Life [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    It consists of 10 items that evaluate perceived well-being in different areas (physical, psychological/emotional, occupational functioning, interpersonal functioning, among others)

  • Overall Anxiety Severity and Impairment Scale [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Fibromyalgia Impact Questionnaire [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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.

  • Brief Symptom Inventory [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    It is a well validated self-report instrument for the measurement of general psychological distress.

  • Self concordance motivation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Eysenck Personality Questionnaire - Revised - Neuroticism [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 85
Study Start Date: October 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: e-BPS intervention
Participants are asked to write and imagine about a future in which they have reached all their goals in four different domains: personal, professional, social and health domain. They carry out the exercise in a Positive Technology System called the "Book of Life", which has shown efficacy in the enhancement of positive mood (Baños, Etchemendy, Farfallini, García-Palacios, Quero & Botella, 2014). This application looks like a personal diary, where participants can write all that they want and these essays are supported by multimedia content (pictures, songs and videos). Additionally, they can continue doing the exercise in a web platform (TEO-Emotional Therapy Online) in which they can visualize all the content they had developed previously.
Behavioral: e-BPS
Placebo Comparator: Daily Activities
Participants are asked to think and write about all that they have done the last 24 hours. They carry out the exercise in a powerpoint document, where they can record all the activities, situations and thoughts.
Behavioral: Daily Activities

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02375061

Contacts
Contact: Cristina Botella, PhD +34 964 38 76 39 ext 7639 botella@uji.es
Contact: Guadalupe Molinari, MA +34 964 38 76 45 ext 7645 guadalupemolinari@gmail.com

Locations
Spain
University Jaume I Recruiting
Castellón, Spain, 12071
Contact: Cristina Botella Arbona, PhD    +34 964 38 76 39 ext 76 39    botella@uji.es   
Contact: Guadalupe Molinari, MA    +34 964 38 76 45 ext 76 45    guadalupemolinari@gmail.com   
Principal Investigator: Azucena García-Palacios, PhD         
Sub-Investigator: Guadalupe Molinari, MA         
Principal Investigator: Cristina Botella, PhD         
Sponsors and Collaborators
Universitat Jaume I
Investigators
Principal Investigator: Azucena García-Palacios, PhD Universitat Jaume I
  More Information

Publications:

Responsible Party: Universitat Jaume I
ClinicalTrials.gov Identifier: NCT02375061     History of Changes
Other Study ID Numbers: UJaime011
Study First Received: February 16, 2015
Last Updated: March 2, 2015
Health Authority: Spain: Ethics Committee

Keywords provided by Universitat Jaume I:
Best Possible Self
Positive Psychology
Optimism
Positive Technologies
Future thinking
Pain Catastrophizing

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Chronic Pain
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Rheumatic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 23, 2015