Brief Summary

The main aim of this pilot study is to study the clinical utility and acceptability of a transdiagnostic psychological intervention, the Unified Protocol, delivered in online format to prevent the onset of emotional disorders in a sample of women undergoing fertility treatments (artificial insemination). The main questions it aims to answer are:

1. Can the Unified Protocol help to prevent the onset of emotional disorders during fertility treatments? The investigators expect to find a maintenance or improvement in anxiety and depressive symptoms as well as on quality of life and fertility-related stress.
2. Would the Unified Protocol delivered in online format be well accepted by women undergoing fertility treatments? The investigators expect to find high satisfaction rates both with the Unified Protocol contents and the online format.

Conditions

• Infertility
• Emotional Disorder
• Anxiety Depression

Intervention / Treatment

• Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Primary Outcome Measures

• Overall Depression Severity and Impairment Scale (ODSIS) (Pre-intervention; Post-intervention, 11 weeks from pre-assessment; 1 month follow-up after post-assessment; 3 months follow-up after post-assessment; 6 months follow-up after post-assessment.)
  This questionnaire consist of 5 items that evaluate the frequency and the intensity of depressive symptoms and their interference in life (e.g., work, school and social life). It is responded on a 5-point Likert scale (0=No depression - 4=The worst depression possible). The total score range from 0 to 20 points. Higher scores are indicative of greater severity and functional impairment as a result of depressive symptoms. In the Spanish population the clinical cut-off has been stablished in 10 points.
• Overall Anxiety Severity and Impairment Scale (OASIS) (Pre-intervention; Post-intervention, 11 weeks from pre-assessment; 1 month follow-up after post-assessment; 3 months follow-up after post-assessment; 6 months follow-up after post-assessment.)
  It consist of 5 items that evaluate the frequency and the intensity of anxious symptoms and their interference with the person's work or school life and social life. It is responded on a 5-point Likert scale (0=No anxiety- 4=The worst anxiety possible). The total score range from 0 to 20 points. Higher scores are indicative of greater severity and functional impairment as a result of anxious symptoms. In the Spanish population the clinical cut-off has been stablished in 10 points.
• Fertility Problem Inventory (FPI) (Pre-intervention; Post-intervention, 11 weeks from pre-assessment; 1 month follow-up after post-assessment; 3 months follow-up after post-assessment; 6 months follow-up after post-assessment.)
  It is composed by 46 items that assess infertility-related stress. It is responded by a 7-points Likert scale (0=completely disagree - 6=completely agree). It is possible to obtain a total score of perceived stress and also it is possible to calculate 5 subscale scores (social concerns, sexual concerns, relationship concerns, need for parenthood and, reject to child-free living). Higher scores indicate greater stress.
• Fertility Quality of Life Questionnaire (FertiQoL) (Pre-intervention; Post-intervention, 11 weeks from pre-assessment; 1 month follow-up after post-assessment; 3 months follow-up after post-assessment; 6 months follow-up after post-assessment.)
  This instrument is composed by 36 items assessing quality of life during fertility treatments. It is responded by a 5-point Likert scale (0=very bad - 4 = very good). Total scores range from 0 to 136 points, higher global scores indicating greater quality of life.
• Difficulties in Emotion Regulation Scale (DERS) (Pre-intervention; Post-intervention, 11 weeks from pre-assessment; 1 month follow-up after post-assessment; 3 months follow-up after post-assessment; 6 months follow-up after post-assessment.)
  Consists of 36-item of six dimension of emotion regulation (nonacceptance of emotions, difficulties in engaging in goal-directed behaviours, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies and lack of emotional clarity). Items are rated on a scale of 1 ("almost never \[0-10%\]") to 5 ("almost always \[91-100%\]"). Higher scores indicate more difficulties in emotion regulation.
• The Multidimensional Emotional Disorder Inventory (MEDI) (Pre-intervention; Post-intervention, 11 weeks from pre-assessment; 1 month follow-up after post-assessment; 3 months follow-up after post-assessment; 6 months follow-up after post-assessment.)
  This is a self-report measure that includes 49 items assessing the main transdiagnostic dimensions of Emotional Disorders: Neurotic Temperament; Positive Temperament; Depressed Mood; Autonomic Arousal; Somatic Anxiety; Social Anxiety; Intrusive Cognitions, Traumatic Re-experiencing; Avoidance. It is responded by a 9-point Likert scale (0=not characteristic of me - 8=extremely characteristic of me). Result for each dimension allows to obtain a profile to emotional disorders.
• Web-page adherence (Post-intervention (11 weeks from pre-intervention assessment).)
  The web automatically records the number of modules completed. At the end of the intervention, the number of modules completed will be analyzed in proportion to the number of modules programmed.
• Adaptation of the Client Satisfaction Questionnaire (CSQ-8) (Post-intervention (11 weeks from pre-intervention assessment).)
  This adaptation is composed of 7 items assessing (a) quality of the intervention and quality of its components, (b) discomfort experienced during treatment, (c) satisfaction with their participation in an online individual format.
• Unified Protocol Satisfaction questionaire (Post-intervention (11 weeks from pre-intervention assessment).)
  It consists of 7 questions that assess the general usefulness of the Unified Protocol to improve emotion regulation skills and the specific usefulness of each of the Unified Protocol skills.

Countries

Spain

Locations and Investigators

• Jorge Osma, Teruel, Spain