NCT02375061

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 13, 2016

Status Verified

April 1, 2016

Enrollment Period

2.7 years

First QC Date

February 16, 2015

Last Update Submit

June 10, 2016

Conditions

FibromyalgiaChronic Pain

Keywords

Best Possible SelfPositive PsychologyOptimismPositive TechnologiesFuture thinkingPain Catastrophizing

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 months

Secondary Outcomes (7)

  • Pain Catastrophizing

    4 months

  • Positive and Negative Affect Scale

    4 months

  • Life Orientation Test

    4 months

  • Quality of Life

    4 months

  • Overall Anxiety Severity and Impairment Scale

    4 months

  • +2 more secondary outcomes

Other Outcomes (4)

  • Fibromyalgia Impact Questionnaire

    4 months

  • Brief Symptom Inventory

    Baseline

  • Self concordance motivation

    Baseline

  • +1 more other outcomes

Study Arms (2)

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.

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.

Behavioral: Daily Activities

Interventions

e-BPSBEHAVIORAL
e-BPS intervention
Daily ActivitiesBEHAVIORAL
Daily Activities

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Jaume I

Castellon, Castellón, 12071, Spain

Location

Related Publications (14)

  • 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.

    PMID: 21450262BACKGROUND

  • 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.

    PMID: 24145210BACKGROUND

  • 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.

    PMID: 23239369BACKGROUND

  • 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.

    PMID: 23084002BACKGROUND

  • Botella 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.

    PMID: 22149078BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 21794391BACKGROUND

  • Garcia 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.

    PMID: 19007576BACKGROUND

  • MacLeod AK. Affect, emotional disorder, and future-directed thinking. Cognition & Emotion 10: 69-86, 1996.

    BACKGROUND

  • 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.

    PMID: 10830568BACKGROUND

  • Bentley 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.

    PMID: 24708078BACKGROUND

  • Peters 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.

    BACKGROUND

  • 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.

    PMID: 3397865BACKGROUND

  • Scheier 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.

    PMID: 7815302BACKGROUND

MeSH Terms

Conditions

FibromyalgiaChronic Pain

Interventions

Activities of Daily Living

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Azucena García-Palacios, PhD

    Universitat Jaume I

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2015

First Posted

March 2, 2015

Study Start

October 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 13, 2016

Record last verified: 2016-04

Locations

ES(1)