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Trial record 52 of 279 for:    Best Disease

Efficacy of a Positive Psychological Intervention in Patients With Eating Disorders

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ClinicalTrials.gov Identifier: NCT03003910
Recruitment Status : Completed
First Posted : December 28, 2016
Last Update Posted : December 28, 2016
Sponsor:
Collaborators:
Hospital Provincial de Castellon
PREVI Clinical Center
Information provided by (Responsible Party):
Angel Enrique Roig, Universitat Jaume I

Brief Summary:
This study is aimed to test the efficacy of a positive psychological intervention for promoting positive emotions and optimistic thinking in eating disordered patients. Participants are randomly assigned to receive the positive intervention or the control condition, which consists on thinking about daily activities.

Condition or disease Intervention/treatment Phase
Eating Disorder Daily Activities Behavioral: Best Possible Self Behavioral: Daily Activities Not Applicable

Detailed Description:

Eating disorders (ED) are very difficult conditions to treat. Therefore, interventions in this field are shifting their main target towards the disorder's impact in quality of life, rather than ED symptomatology in itself. In this sense, a focus in the promotion of positive emotions and well-being is emerging in order to buffer from the harmful effects caused by ED.

Positive psychological interventions have shown efficacy in the promotion of positive emotions and well-being. In this sense, one of these interventions is called Best Possible Self (BPS), since is aimed to enhance positive emotions and well-being. Specifically, BPS is a positive future thinking technique, which requires people to envision themselves in the future, after everything has gone as good as it possibly could. This exercise has shown efficacy improving optimism, future expectancies and positive affect compared to a control condition, in general population and depressive patients.

Furthermore, the progress of Information and Communication Technologies, has allowed the development of technology applications and devices that could enhance the quality of experience and the well-being levels. This approach is called Positive Technology and it can be used as a complement to positive psychological interventions. Positive Technology can be defined as the scientific and applied approach to improve the quality of our personal experience trying to increase wellness and generate strengths.

Taking into account the prior literature, the aim of the present study is to carry out a randomized controlled study with ED patients in order to explore if BPS is able to produce improvements in different well-being and clinical measures. The exercise will be applied through a Positive Technology system. The design employed in this study is similar to the used in other studies.

Five assessment moments were used: Before the exercise (baseline), after the first session (day 1) and post-training (1 month). Moreover, two follow-ups were included: one month after finishing the training period (1st follow-up) and three months after finishing the training (2nd follow-up)


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of a Positive Psychological Intervention in Patients With Eating Disorders: a Randomized Control Trial
Study Start Date : February 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Experimental: Best Possible Self

Participants are asked to write and imagine about a future in which they have reached all their goals and they have developed all their potentialities 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 in which they can visualize all the content they had developed previously.

Behavioral: Best Possible Self
Intervention group which requires people to envision themselves in a future in which all has gone in the best possible way.
Other Name: Positive Psychological Intervention

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 occurred in the past 24 hours.
Behavioral: Daily Activities
Control group which consists of thinking and writing about all the activities and situations that had taken place during the last 24 h.




Primary Outcome Measures :
  1. Subjective Probability Task (SPT; MacLeod, 1996). Change assessment. [ Time Frame: Baseline, day 1, 1 month, 2 months, 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 y 0.91, respectively).

  2. Positive and Negative Affect Scale (PANAS, Watson, Clark & Tellegen, 1988; Sandín et al., 1999). Change assessment. [ Time Frame: Baseline, day 1, 1 month, 2 months, 4 months ]
    To measure affect, the Spanish adaptation of the Positive and Negative Affect Scale was used (PANAS, Sandín et al., 1999; Watson, Clark & Tellegen, 1988). This instrument is composed of 20 items: 10 items measuring positive affective states and 10 items measuring negative affect states. Participants rate on a five-point scale (from "Not at all" to "Extremely") the degree to which they usually feel a specific affective state. PANAS is one of the most widely-used instruments to measure affect because it shows excellent psychometric properties (Cronbach Alpha's from 0.87-0.91).


Secondary Outcome Measures :
  1. Life Orientation Test (Lot-R; Otero, Luengo, Romero Gómez & Castro, 1998; Scheier, Carver & Bridges, 1994). Change assessment. [ Time Frame: Baseline, 1 month, 2 months, 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 y 0.91, respectively).

  2. General Self Efficacy Scale-12 (GSES-12; Bosscher et al., 1997; Herrero et al., 2014). Change assessment. [ Time Frame: Baseline, 1 month, 2 months, 4 months ]
    This questionnaire evaluates a general dimension and three aspects of self-efficacy: initiative, persistence and effort. The internal consistency coefficients for the subscales varied from excellent to good (Initiative = 0.83; Effort =0.77; Persistence = 0.80; and Total = 0.86).

  3. Dispositional Hope Scale (DHS; Snyder et al., 1991). Change assessment. [ Time Frame: Baseline, 1 month, 2 months, 4 months ]
    This instrument evaluates dispositional hope. It is composed of 12 items (Agency: 4 items; Pathways= 4 items; Fillers= 4 items), with an 8-point Likert scale ranging from 1 (definitely false) to 8 (definitely true). Internal consistency coefficient (Cronbach's alpha) for the total scale was excellent (.89).

  4. Self-Concordant Motivation (SCM; Sheldon & Elliot, 1999) [ Time Frame: day 1 ]
    This instrument assesses participants' initial motivation to do the assigned exercise. It explores the different reasons for the participants to carry out the exercise. The scale is composed of 4 items whose goal is to find out whether the motivation is intrinsic or extrinsic. A total score is obtained by subtracting the two extrinsic motivation scores from the two intrinsic motivation scores.


Other Outcome Measures:
  1. Eysenck Personality Questionnaire - Revised - Neuroticism (EPQ-R-N; Eysenck, Eysenck & Barrett, 1985; Eysenck & Eysenck, 1997). [ 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, Eysenck and Eysenck (1997) got an alpha coefficient between 0-73 and 0.82.

  2. Eating Attitudes Test (EAT-26; Garner, Olmsted, Bohr & Garfinkel, 1982) [ Time Frame: Baseline ]
    This questionnaire assesses a broad range of attitudes and behaviors related to anorexia nervosa. It is composed of 26 items rated on a 6-point Likert scale from 0 (never) to 6 (always), based on the frequency with which the individual carries out the behavior or has the thought described by the item. The instrument has shown excellent psychometric properties (Toro, Castro, Garcia, Perez & Cuesta, 1989; Rivas, Bersabé, Jiménez & Berrocal, 2010).

  3. Brief Symptom Inventory (Ruipérez, Ibañez, Lorente, Moro & Ortet, 2001) [ Time Frame: Baseline ]
    This scale encompass ninve primary dimensions of psychopathological symptoms: psychoticism, somatization, depression, hostility, phobic anxiety, obsessive-compulsive, anxiety (panic), paranoid ideation, and nervous tension. Each BSI item is rated on a 5- point scale (0 to 4) according to manifestations of symptoms in the last 30 days (ranging from "not at-all" to "extremely").



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has a diagnosis of Eating Disorder by a Clinical Psychologist according to DSM-IV criteria
  • Subject accepts to participate in the study voluntarily

Exclusion Criteria:

  • Subject suffering a severe physical condition
  • Subject suffering from substance or alcohol depedence

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003910


Locations
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Spain
University Jaume I
Castellón, Spain, 12006
Sponsors and Collaborators
Universitat Jaume I
Hospital Provincial de Castellon
PREVI Clinical Center
Investigators
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Study Director: Cristina Botella, Professor University Jaume I

Publications:
Pietrowsky, R., & Mikutta, J. (2012). Effects of positive psychology interventions in depressive patients—A randomized control study. Psychology, 3(12), 1067. doi: 10.4236/psych.2012.312158.
Sheldon, K. M., & 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Angel Enrique Roig, Ph.D Student, Universitat Jaume I
ClinicalTrials.gov Identifier: NCT03003910     History of Changes
Other Study ID Numbers: aenrique
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: December 28, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Angel Enrique Roig, Universitat Jaume I:
Best Possible Self

Additional relevant MeSH terms:
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Disease
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders