Efficacy of a Positive Psychological Intervention in Patients With Eating Disorders

Eating Disorder Clinical Trial

Official title:

Efficacy of a Positive Psychological Intervention in Patients With Eating Disorders: a Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03003910
• Other study ID #: aenrique
• Status: Completed
• Phase: N/A
• First received: December 19, 2016
• Last updated: December 27, 2016
• Start date: February 2013
• Est. completion date: November 2015

Study information

• Verified date: December 2016
• Source: Universitat Jaume I
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Daily Activities
• Disease
• Eating Disorder
• Feeding and Eating Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	University Jaume I	Castellón

Sponsors (3)

Lead Sponsor	Collaborator
Universitat Jaume I	Hospital Provincial de Castellon, PREVI Clinical Center

Country where clinical trial is conducted

Spain, 

References & Publications (9)

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. — View Citation

Botella C, Riva G, Gaggioli A, Wiederhold BK, Alcaniz M, Baños RM. The present and future of positive technologies. Cyberpsychol Behav Soc Netw. 2012 Feb;15(2):78-84. doi: 10.1089/cyber.2011.0140. — View 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. — View 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. — View 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. — View 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.

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. — View 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.

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Eysenck Personality Questionnaire - Revised - Neuroticism (EPQ-R-N; Eysenck, Eysenck & Barrett, 1985; Eysenck & Eysenck, 1997).	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.	Baseline	No
Other	Eating Attitudes Test (EAT-26; Garner, Olmsted, Bohr & Garfinkel, 1982)	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).	Baseline	No
Other	Brief Symptom Inventory (Ruipérez, Ibañez, Lorente, Moro & Ortet, 2001)	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").	Baseline	No
Primary	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 (a=0.80-0.82 y 0.91, respectively).	Baseline, day 1, 1 month, 2 months, 4 months	No
Primary	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	No
Secondary	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 (a=0.80-0.82 y 0.91, respectively).	Baseline, 1 month, 2 months, 4 months	No
Secondary	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).	Baseline, 1 month, 2 months, 4 months	No
Secondary	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).	Baseline, 1 month, 2 months, 4 months	No
Secondary	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.	day 1	No