Clinical trial NCT03003910: 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
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorder
Daily Activities
Keywords: Best Possible Self
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
Collaborators: name: Hospital Provincial de Castellon
name: PREVI Clinical Center
First posted: 2016-12-28
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Subjective Probability Task (SPT; MacLeod, 1996). Change assessment.
timeFrame: Baseline, day 1, 1 month, 2 months, 4 months
measure: Positive and Negative Affect Scale (PANAS, Watson, Clark & Tellegen, 1988; Sandín et al., 1999). Change assessment.
timeFrame: Baseline, day 1, 1 month, 2 months, 4 months
Secondary outcomes:
measure: Life Orientation Test (Lot-R; Otero, Luengo, Romero Gómez & Castro, 1998; Scheier, Carver & Bridges, 1994). Change assessment.
timeFrame: Baseline, 1 month, 2 months, 4 months
measure: General Self Efficacy Scale-12 (GSES-12; Bosscher et al., 1997; Herrero et al., 2014). Change assessment.
timeFrame: Baseline, 1 month, 2 months, 4 months
measure: Dispositional Hope Scale (DHS; Snyder et al., 1991). Change assessment.
timeFrame: Baseline, 1 month, 2 months, 4 months
measure: Self-Concordant Motivation (SCM; Sheldon & Elliot, 1999)
timeFrame: day 1
Other outcomes:
measure: Eysenck Personality Questionnaire - Revised - Neuroticism (EPQ-R-N; Eysenck, Eysenck & Barrett, 1985; Eysenck & Eysenck, 1997).
timeFrame: Baseline
measure: Eating Attitudes Test (EAT-26; Garner, Olmsted, Bohr & Garfinkel, 1982)
timeFrame: Baseline
measure: Brief Symptom Inventory (Ruipérez, Ibañez, Lorente, Moro & Ortet, 2001)
timeFrame: Baseline
Locations:
city: Castellón
country: Spain
facility: University Jaume I
Study officials:
affiliation: University Jaume I
name: Cristina Botella, Professor
role: STUDY_DIRECTOR
References:
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.
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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.
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.
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.
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.