FibromyalgiaBPS_FMNCT02375061
A Positive Psychology Intervention for Fibromyalgia Patients Using ICT´s
A study testing e-BPS and Daily Activities in people with Fibromyalgia and Chronic Pain, run by Universitat Jaume I at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Chronic Pain
- What is being tested?
- e-BPS and Daily Activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2013to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients have to fulfill the American College of Rheumatology criteria for primary FMS.
- Sign a consent form stating their willingness to participate
Who cannot join
- Presence of another severe physical illness
- Presence of severe psychological disorders
- Be currently involved in another psychological treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Positive Psychology Intervention for Fibromyalgia Patients to Promote Physical and Psychological Wellbeing Using Information and Communication Technologies
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.
Read the 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).
- Conditions
- Fibromyalgia, Chronic Pain
- Being tested
- e-BPS, Daily Activities
- Keywords
- Best Possible Self, Positive Psychology, Optimism, Positive Technologies, Future thinking, Pain Catastrophizing
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-BPSBehavioural
Daily ActivitiesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| e-BPS intervention | Experimental | 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. Receives: Behavioral: e-BPS |
| Daily Activities | Placebo comparator | 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. Receives: Behavioral: Daily Activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory II
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.
Measured: 4 months
Secondary outcomes (7)
Pain Catastrophizing
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).
Measured: 4 months
Positive and Negative Affect Scale
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.
Measured: 4 months
Life Orientation Test
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).
Measured: 4 months
Quality of Life
It consists of 10 items that evaluate perceived well-being in different areas (physical, psychological/emotional, occupational functioning, interpersonal functioning, among others)
Measured: 4 months
Overall Anxiety Severity and Impairment Scale
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.
Measured: 4 months
General Self-Efficacy scale
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).
Measured: 4 months
Subjective probability task
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).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startOct 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Azucena García-Palacios, PhD, Principal investigator, Universitat Jaume I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375061
- Sponsor's protocol ID
- UJaime011
- Acronym
- BPS_FM
- Status last verified
- Apr 2016
- First submitted
- 16 Feb 2015
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21450262Boselie 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.
PubMed 24145210Hanssen 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.
PubMed 23239369Hanssen 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.
PubMed 23084002Botella C, Riva G, Gaggioli A, Wiederhold BK, Alcaniz M, Banos RM. The present and future of positive technologies. Cyberpsychol Behav Soc Netw. 2012 Feb;15(2):78-84. doi: 10.1089/cyber.2011.0140. Epub 2011 Dec 9.
PubMed 22149078Sheldon, 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.
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.
PubMed 21794391Garcia Campayo J, Rodero B, Alda M, Sobradiel N, Montero J, Moreno S. [Validation of the Spanish version of the Pain Catastrophizing Scale in fibromyalgia]. Med Clin (Barc). 2008 Oct 18;131(13):487-92. doi: 10.1157/13127277. Spanish.
PubMed 19007576MacLeod AK. Affect, emotional disorder, and future-directed thinking. Cognition & Emotion 10: 69-86, 1996.
Mezzich JE, Ruiperez MA, Perez C, Yoon G, Liu J, Mahmud S. The Spanish version of the quality of life index: presentation and validation. J Nerv Ment Dis. 2000 May;188(5):301-5. doi: 10.1097/00005053-200005000-00008.
PubMed 10830568Bentley KH, Gallagher MW, Carl JR, Barlow DH. Development and validation of the Overall Depression Severity and Impairment Scale. Psychol Assess. 2014 Sep;26(3):815-830. doi: 10.1037/a0036216. Epub 2014 Apr 7.
PubMed 24708078Peters ML, Flink IK, Boersma K, Linton SJ. Manipulating optimism: can imagining a best possible self be used to increase positive future expectancies? Journal of Positive Psychology 5: 204-211, 2010.
Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
PubMed 3397865Scheier MF, Carver CS, Bridges MW. Distinguishing optimism from neuroticism (and trait anxiety, self-mastery, and self-esteem): a reevaluation of the Life Orientation Test. J Pers Soc Psychol. 1994 Dec;67(6):1063-78. doi: 10.1037//0022-3514.67.6.1063.
PubMed 7815302
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Positive Psychology Intervention for Fibromyalgia Patients to Promote Physical and Psychological Wellbeing Using Information and Communication Technologies
- ClinicalTrials.gov ID
- NCT02375061
- Acronym / sponsor ID
- BPS_FM / UJaime011
- Conditions
- Fibromyalgia, Chronic Pain
- Keywords
- Best Possible Self, Positive Psychology, Optimism, Positive Technologies, Future thinking, Pain Catastrophizing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| e-BPS intervention | Experimental | Behavioral: e-BPSParticipants 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. |
| Daily Activities | Placebo comparator | Behavioral: Daily ActivitiesParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients have to fulfill the American College of Rheumatology criteria for primary FMS.
- Sign a consent form stating their willingness to participate
Key exclusion criteria (3 listed)
- Presence of another severe physical illness
- Presence of severe psychological disorders
- Be currently involved in another psychological treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-BPS | Behavioural | e-BPS intervention |
| Daily Activities | Behavioural | Daily Activities |
Primary outcome
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.
7 secondary outcomes
Pain Catastrophizing
Time frame: 4 months
Positive and Negative Affect Scale
Time frame: 4 months
Life Orientation Test
Time frame: 4 months
Quality of Life
Time frame: 4 months
Overall Anxiety Severity and Impairment Scale
Time frame: 4 months
General Self-Efficacy scale
Time frame: 4 months
Subjective probability task
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2016.
- Background: PubMed 21450262Meevissen 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.
- Background: PubMed 24145210Boselie 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.
- Background: PubMed 23239369Hanssen 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.
- Background: PubMed 23084002Hanssen 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.
- Background: PubMed 22149078Botella C, Riva G, Gaggioli A, Wiederhold BK, Alcaniz M, Banos RM. The present and future of positive technologies. Cyberpsychol Behav Soc Netw. 2012 Feb;15(2):78-84. doi: 10.1089/cyber.2011.0140. Epub 2011 Dec 9.
- BackgroundSheldon, 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.
- Background: PubMed 21794391Esteve-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.
- Background: PubMed 19007576Garcia Campayo J, Rodero B, Alda M, Sobradiel N, Montero J, Moreno S. [Validation of the Spanish version of the Pain Catastrophizing Scale in fibromyalgia]. Med Clin (Barc). 2008 Oct 18;131(13):487-92. doi: 10.1157/13127277. Spanish.
- BackgroundMacLeod AK. Affect, emotional disorder, and future-directed thinking. Cognition & Emotion 10: 69-86, 1996.
- Background: PubMed 10830568Mezzich JE, Ruiperez MA, Perez C, Yoon G, Liu J, Mahmud S. The Spanish version of the quality of life index: presentation and validation. J Nerv Ment Dis. 2000 May;188(5):301-5. doi: 10.1097/00005053-200005000-00008.
- Background: PubMed 24708078Bentley KH, Gallagher MW, Carl JR, Barlow DH. Development and validation of the Overall Depression Severity and Impairment Scale. Psychol Assess. 2014 Sep;26(3):815-830. doi: 10.1037/a0036216. Epub 2014 Apr 7.
- BackgroundPeters ML, Flink IK, Boersma K, Linton SJ. Manipulating optimism: can imagining a best possible self be used to increase positive future expectancies? Journal of Positive Psychology 5: 204-211, 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azucena García-Palacios, PhD principal investigator
Universitat Jaume I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-BPS and Daily Activities in people with Fibromyalgia and Chronic Pain, run by Universitat Jaume I at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory II (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02375061, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2016.