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Completed

NCT Number: NCT03003910

Efficacy of a Positive Psychological Intervention in Patients With Eating Disorders

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Jaume I

Castellon, Castellón, 12006, Spain

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Possible Self

Behavioral

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

Other names: Positive Psychological Intervention

Daily activities

Behavioral

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

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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

    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).

  2. 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

    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).

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

    Time frame: Baseline, 1 month, 2 months, 4 months

    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).

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

    Time frame: day 1

    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.

Other outcomes

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

    Time frame: Baseline

    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.

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

    Time frame: Baseline

    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).

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

    Time frame: Baseline

    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").

Sponsors and collaborators

Lead sponsor

Universitat Jaume I

Other

Collaborators

  • Hospital Provincial de Castellon
  • PREVI Clinical Center

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 28, 2016
Registry last updated
Dec 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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