NCT03003910

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 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

February 1, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
Last Updated

December 28, 2016

Status Verified

December 1, 2016

Enrollment Period

2.7 years

First QC Date

December 19, 2016

Last Update Submit

December 27, 2016

Conditions

Keywords

Best Possible Self

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    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.

    Baseline, 1 month, 2 months, 4 months

  • General Self Efficacy Scale-12 (GSES-12; Bosscher et al., 1997; Herrero et al., 2014). Change assessment.

    Baseline, 1 month, 2 months, 4 months

  • Dispositional Hope Scale (DHS; Snyder et al., 1991). Change assessment.

    Baseline, 1 month, 2 months, 4 months

  • Self-Concordant Motivation (SCM; Sheldon & Elliot, 1999)

    day 1

Other Outcomes (3)

  • Eysenck Personality Questionnaire - Revised - Neuroticism (EPQ-R-N; Eysenck, Eysenck & Barrett, 1985; Eysenck & Eysenck, 1997).

    Baseline

  • Eating Attitudes Test (EAT-26; Garner, Olmsted, Bohr & Garfinkel, 1982)

    Baseline

  • Brief Symptom Inventory (Ruipérez, Ibañez, Lorente, Moro & Ortet, 2001)

    Baseline

Study Arms (2)

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.

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.

Behavioral: Daily Activities

Interventions

Intervention group which requires people to envision themselves in a future in which all has gone in the best possible way.

Also known as: Positive Psychological Intervention
Best Possible Self

Control group which consists of thinking and writing about all the activities and situations that had taken place during the last 24 h.

Daily Activities

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Jaume I

Castellon, Castellón, 12006, Spain

Location

Related Publications (10)

  • 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.

    PMID: 24041479BACKGROUND
  • 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
  • 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
  • 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.

    BACKGROUND
  • 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.

    PMID: 24252218BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 24594747BACKGROUND
  • 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.

    PMID: 16864242BACKGROUND
  • 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.

    PMID: 25413641BACKGROUND
  • 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.

MeSH Terms

Conditions

Feeding and Eating Disorders

Interventions

Activities of Daily Living

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Cristina Botella, Professor

    University Jaume I

    STUDY DIRECTOR

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
PRINCIPAL INVESTIGATOR
PI Title
Ph.D Student

Study Record Dates

First Submitted

December 19, 2016

First Posted

December 28, 2016

Study Start

February 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

December 28, 2016

Record last verified: 2016-12

Locations