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Efficacy of a Positive Psychological Intervention in Patients With Eating Disorders

Primary Purpose

Eating Disorder, Daily Activities

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Best Possible Self
Daily Activities
Sponsored by
Universitat Jaume I
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorder focused on measuring Best Possible Self

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Jaume I

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Best Possible Self

Daily Activities

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Subjective Probability Task (SPT; MacLeod, 1996). Change assessment.
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).
Positive and Negative Affect Scale (PANAS, Watson, Clark & Tellegen, 1988; Sandín et al., 1999). Change assessment.
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

Life Orientation Test (Lot-R; Otero, Luengo, Romero Gómez & Castro, 1998; Scheier, Carver & Bridges, 1994). Change assessment.
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).
General Self Efficacy Scale-12 (GSES-12; Bosscher et al., 1997; Herrero et al., 2014). Change assessment.
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).
Dispositional Hope Scale (DHS; Snyder et al., 1991). Change assessment.
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).
Self-Concordant Motivation (SCM; Sheldon & Elliot, 1999)
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.

Full Information

First Posted
December 19, 2016
Last Updated
December 27, 2016
Sponsor
Universitat Jaume I
Collaborators
Hospital Provincial de Castellon, PREVI Clinical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03003910
Brief Title
Efficacy of a Positive Psychological Intervention in Patients With Eating Disorders
Official Title
Efficacy of a Positive Psychological Intervention in Patients With Eating Disorders: a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Jaume I
Collaborators
Hospital Provincial de Castellon, PREVI Clinical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder, Daily Activities
Keywords
Best Possible Self

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Best Possible Self
Arm Type
Experimental
Arm Description
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.
Arm Title
Daily Activities
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Best Possible Self
Other Intervention Name(s)
Positive Psychological Intervention
Intervention Description
Intervention group which requires people to envision themselves in a future in which all has gone in the best possible way.
Intervention Type
Behavioral
Intervention Name(s)
Daily Activities
Intervention Description
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 Measure Information:
Title
Subjective Probability Task (SPT; MacLeod, 1996). Change assessment.
Description
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).
Time Frame
Baseline, day 1, 1 month, 2 months, 4 months
Title
Positive and Negative Affect Scale (PANAS, Watson, Clark & Tellegen, 1988; Sandín et al., 1999). Change assessment.
Description
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).
Time Frame
Baseline, day 1, 1 month, 2 months, 4 months
Secondary Outcome Measure Information:
Title
Life Orientation Test (Lot-R; Otero, Luengo, Romero Gómez & Castro, 1998; Scheier, Carver & Bridges, 1994). Change assessment.
Description
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).
Time Frame
Baseline, 1 month, 2 months, 4 months
Title
General Self Efficacy Scale-12 (GSES-12; Bosscher et al., 1997; Herrero et al., 2014). Change assessment.
Description
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).
Time Frame
Baseline, 1 month, 2 months, 4 months
Title
Dispositional Hope Scale (DHS; Snyder et al., 1991). Change assessment.
Description
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).
Time Frame
Baseline, 1 month, 2 months, 4 months
Title
Self-Concordant Motivation (SCM; Sheldon & Elliot, 1999)
Description
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.
Time Frame
day 1
Other Pre-specified Outcome Measures:
Title
Eysenck Personality Questionnaire - Revised - Neuroticism (EPQ-R-N; Eysenck, Eysenck & Barrett, 1985; Eysenck & Eysenck, 1997).
Description
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.
Time Frame
Baseline
Title
Eating Attitudes Test (EAT-26; Garner, Olmsted, Bohr & Garfinkel, 1982)
Description
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).
Time Frame
Baseline
Title
Brief Symptom Inventory (Ruipérez, Ibañez, Lorente, Moro & Ortet, 2001)
Description
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").
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina Botella, Professor
Organizational Affiliation
University Jaume I
Official's Role
Study Director
Facility Information:
Facility Name
University Jaume I
City
Castellón
ZIP/Postal Code
12006
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24041479
Citation
Bolier L, Haverman M, Kramer J, Westerhof GJ, Riper H, Walburg JA, Boon B, Bohlmeijer E. An Internet-based intervention to promote mental fitness for mildly depressed adults: randomized controlled trial. J Med Internet Res. 2013 Sep 16;15(9):e200. doi: 10.2196/jmir.2603.
Results Reference
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PubMed Identifier
22149078
Citation
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.
Results Reference
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PubMed Identifier
21450262
Citation
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.
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
24252218
Citation
Renner F, Schwarz P, Peters ML, Huibers MJ. Effects of a best-possible-self mental imagery exercise on mood and dysfunctional attitudes. Psychiatry Res. 2014 Jan 30;215(1):105-10. doi: 10.1016/j.psychres.2013.10.033. Epub 2013 Nov 1.
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
24594747
Citation
Dawson L, Rhodes P, Touyz S. "Doing the impossible": the process of recovery from chronic anorexia nervosa. Qual Health Res. 2014 Apr;24(4):494-505. doi: 10.1177/1049732314524029. Epub 2014 Mar 4.
Results Reference
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PubMed Identifier
16864242
Citation
Noordenbos G, Oldenhave A, Muschter J, Terpstra N. Characteristics and treatment of patients with chronic eating disorders. Eat Disord. 2002 Spring;10(1):15-29. doi: 10.1080/106402602753573531.
Results Reference
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PubMed Identifier
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Citation
Tchanturia K, Dapelo MA, Harrison A, Hambrook D. Why study positive emotions in the context of eating disorders? Curr Psychiatry Rep. 2015 Jan;17(1):537. doi: 10.1007/s11920-014-0537-x.
Results Reference
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Citation
Enrique A, Breton-Lopez J, Molinari G, Roca P, Llorca G, Guillen V, Fernandez-Aranda F, Banos RM, Botella C. Implementation of a Positive Technology Application in Patients With Eating Disorders: A Pilot Randomized Control Trial. Front Psychol. 2018 Jun 11;9:934. doi: 10.3389/fpsyg.2018.00934. eCollection 2018.
Results Reference
derived

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Efficacy of a Positive Psychological Intervention in Patients With Eating Disorders

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