Eating DisorderNCT03003910
Efficacy of a Positive Psychological Intervention in Patients With Eating Disorders
A study testing Best Possible Self and Daily Activities in people with Eating Disorder and Daily Activities, run by Universitat Jaume I at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Eating Disorder, Daily Activities
- What is being tested?
- Best Possible Self 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
- 54 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2013to Nov 2015
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a diagnosis of Eating Disorder by a Clinical Psychologist according to DSM-IV criteria
- Subject accepts to participate in the study voluntarily
Who cannot join
- Subject suffering a severe physical condition
- Subject suffering from substance or alcohol depedence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Positive Psychological Intervention in Patients With Eating Disorders: a Randomized Control Trial
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.
Read the 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)
- Conditions
- Eating Disorder, Daily Activities
- Being tested
- Best Possible Self, Daily Activities
- Keywords
- Best Possible Self
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best Possible SelfBehavioural
Also called Positive Psychological Intervention
Intervention group which requires people to envision themselves in a future in which all has gone in the best possible way.
Daily ActivitiesBehavioural
Control group which consists of thinking and writing about all the activities and situations that had taken place during the last 24 h.
| Study group | Role | What they receive |
|---|---|---|
| Best Possible Self | Experimental | 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. Receives: Behavioral: Best Possible Self |
| 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 occurred in the past 24 hours. Receives: Behavioral: Daily Activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, day 1, 1 month, 2 months, 4 months
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).
Measured: Baseline, day 1, 1 month, 2 months, 4 months
Secondary outcomes (4)
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).
Measured: Baseline, 1 month, 2 months, 4 months
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).
Measured: Baseline, 1 month, 2 months, 4 months
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).
Measured: Baseline, 1 month, 2 months, 4 months
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.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startFeb 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Eating DisorderStudies 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Provincial de Castellon, PREVI Clinical Center
- Responsible party
- Principal investigator, Angel Enrique Roig, Universitat Jaume I
- Investigators
- Cristina Botella, Professor, Study director, University Jaume I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003910
- Sponsor's protocol ID
- aenrique
- Status last verified
- Dec 2016
- First submitted
- 19 Dec 2016
- Last updated
- 28 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24041479Botella 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 22149078Meevissen 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 21450262Pietrowsky, 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.
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.
PubMed 24252218Sheldon, 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.
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.
PubMed 24594747Noordenbos 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.
PubMed 16864242Tchanturia 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.
PubMed 25413641Enrique 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.
PubMed 29942272
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Positive Psychological Intervention in Patients With Eating Disorders: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03003910
- Acronym / sponsor ID
- aenrique
- Conditions
- Eating Disorder, Daily Activities
- Keywords
- Best Possible Self
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Collaborators
- Hospital Provincial de Castellon, PREVI Clinical Center
- Study start
- Feb 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 28 Dec 2016 (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 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best Possible Self | Experimental | Behavioral: Best Possible SelfParticipants 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. |
| 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 occurred in the past 24 hours. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has a diagnosis of Eating Disorder by a Clinical Psychologist according to DSM-IV criteria
- Subject accepts to participate in the study voluntarily
Key exclusion criteria (2 listed)
- Subject suffering a severe physical condition
- Subject suffering from substance or alcohol depedence
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 |
|---|---|---|
| Best Possible SelfAlso: Positive Psychological InterventionIntervention group which requires people to envision themselves in a future in which all has gone in the best possible way. | Behavioural | Best Possible Self |
| Daily ActivitiesControl group which consists of thinking and writing about all the activities and situations that had taken place during the last 24 h. | Behavioural | Daily Activities |
Primary outcome
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).
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).
4 secondary outcomes
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
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
Dispositional Hope Scale (DHS; Snyder et al., 1991). Change assessment.
Time frame: Baseline, 1 month, 2 months, 4 months
Self-Concordant Motivation (SCM; Sheldon & Elliot, 1999)
Time frame: day 1
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 28 Dec 2016.
- Background: PubMed 24041479Bolier 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.
- 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.
- 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.
- BackgroundPietrowsky, 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.
- Background: PubMed 24252218Renner 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.
- BackgroundSheldon, 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.
- Background: PubMed 24594747Dawson 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.
- Background: PubMed 16864242Noordenbos 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.
- Background: PubMed 25413641Tchanturia 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.
- Derived from this study: PubMed 29942272Enrique 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.
- Individual participant dataSharing planned: Undecided
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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.
Cristina Botella, Professor study director
University 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 Best Possible Self and Daily Activities in people with Eating Disorder and Daily Activities, 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 2 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 28 Dec 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?
Subjective Probability Task (SPT; MacLeod, 1996). Change assessment. (time frame: Baseline, day 1, 1 month, 2 months, 4 months). The study lists 2 primary outcomes in all. 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 NCT03003910, which also lists 10 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 28 Dec 2016.