An Internet-based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)

Study Overview
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Brief Summary
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The purpose of this study is to investigate the feasibility, acceptability and preliminary efficacy of an internet delivered cognitive behavior treatment (ICBT) for people with prolonged grief disorder (PGD) compared to a face-to-face intervention for PGD.

Detailed Description
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Grief is an intense emotional reaction to the loss of a loved one. It produces feelings of regret and longing that usually decrease over time. However, some people have difficulty adapting to the loss and develop Prolonged Grief Disorder (PGD). An open clinical trial will be conducted to investigate the feasibility [initial efficacy and acceptability] of an Internet delivered cognitive behavior treatment (ICBT) for adult people diagnosed with prolonged grief disorder (PGD). There will be at least 24 participants that will be randomly assigned to experimental group (internet-based treatment for PGD) or active control group (traditional face- to-face intervention for PGD). Four assessment moments will be included (pre-treatment, post-treatment, 3 months follow-up and 12 months follow-up). The present study aims to improve knowledge about the feasibility, acceptability and preliminary efficacy of an ICBT for PGD and conduct a preliminary comparison between two intervention conditions (internet-based intervention vs. traditional face-to-face intervention). Also, the investigators aim to collect information that can help to improve the efficacy and acceptability of Internet-based interventions in general.

Official Title
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Internet-based Self Applied Treatment Program for Prolonged Grief Disorder (PGD): An Open Clinical Trial

Conditions
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Prolonged Grief Disorder

Intervention / Treatment
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* Behavioral: Internet-based Self Applied Treatment Program
* Behavioral: Videoconference treatment with a therapist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Meeting diagnostic criteria for PGD Sign an informed consent Ability to understand and read Spanish Ability to use a computer and having access to the Internet Having an e-mail address Exclusion Criteria: Presence of risk of suicide or self-destructive behaviors Presence of another severe mental disorder (substance abuse or dependence, psychotic disorder, dementia o bipolar disorder) Presence of severe personality disorder Presence of a medical condition whose severity or characteristics prevent the performance of treatment Receiving other psychological treatment during the study for PGD An increase and/or change in the medication during the study period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based intervention<br>Internet-based Self Applied Treatment Program. Main components: Motivation for change, Psychoeducation, Behavioral activation, Exposure, Mindfulness and compassion strategies, integration of loss, restoration and reconstruction of meaning, Cognitive reappraisal and Relapse prevention. | Behavioral: Internet-based Self Applied Treatment Program<br>* It is a self-applied treatment for PGD through the web psicologíaytecnología.labpsitec.es. There are 8 treatment modules. Each module lasts approximately 60 minutes. It contains written information, videos, audios, photos and interactive questionnaires. The total duration of treatment is up to 8-10 weeks. A weekly support call will be made (maximum 10 minutes) to answer questions and reinforce and motivate the patient. No additional clinical content or counselling will be provided. Main components of the treatment: Motivation for change, Psychoeducation, Behavioral activation, Exposure, Mindfulness and compassion strategies, integration of loss, restoration and reconstruction of meaning, Cognitive reappraisal and Relapse prevention<br>* Other names: GROw;|
| Active Comparator: Face-to-face treatment by videoconference<br>Face-to-face Intervention by videoconference applied by a therapist: Main components: Motivation for change, Psychoeducation, Behavioral activation, Exposure, Mindfulness and compassion strategies, integration of loss, restoration and reconstruction of meaning, Cognitive reappraisal and Relapse prevention. | Behavioral: Videoconference treatment with a therapist<br>* It is a treatment for PGD applied by a therapist composed of 8-10 treatment sessions. Each session lasts approximately 60 minutes. No weekly support call will be provided. The sessions will take place by videoconference. Main components of the treatment: Motivation for change, Psychoeducation, Behavioral activation, Exposure, Mindfulness and compassion strategies, integration of loss, restoration and reconstruction of meaning, Cognitive reappraisal and Relapse prevention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Inventory of Complicated Grief (ICG) validated in the Spanish population | It is a self-applied instrument that assesses grief symptoms in adults. Good psychometric properties; cronbach's alpha of0.94 in the original version and 0.88 in the Spanish adaptation. It consists of 19 items with five response categories (Likert): 0; never 1; rarely 2; sometimes 3; often and 4; forever. The items value the frequency of the symptom explored (emotional, cognitive or behavioral). It is completed in approximately 10 minutes. The total score is calculated by adding the score of the 19 items. The total score ranges from 0 to 76, with highest scores corresponding to a greater probability of suffering complicated grief. | immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment | 
| Change in the Beck Depression Inventory - Second Edition validated in the Spanish population | It is a self-applied instrument that assesses characteristic attitudes and symptoms of depression. Psychometric properties; Cronbach's alpha of 0.76 to 0.95 and test-retest reliability of around 0.8. It consists of 21 items that are scored on a scale from 0 to 3. It is calculated by adding the score of the 21 items and the maximum total score is 63. | immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Overall Anxiety Severity and Impairment Scale (OASIS) validated in the Spanish population | It is a self-applied instrument to assess the frequency and severity of anxiety. It also measures the level of avoidance, work, academic, and home interference, and social interference associated with anxiety. Psychometric properties; Cronbach's alpha of 0.80 in the original version and 0.86 in the Spanish adaptation. It consists of 5 items that are scored on a scale of 0 to 4. It is calculated by adding the score of the 5 items and the maximum score is 20. | immediately pre-treatment, weekly during treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment | 
| Change in the Overall Depression Severity and Impairment Scale (ODSIS) validated in the Spanish population | It is a self-applied instrument to assess the frequency and severity of depression. It also measures the level of avoidance, work, academic, and home interference, and social interference associated with depression. Psychometric properties; Cronbach's alpha of 0.91 to 0.94 in the original version and good convergent and discriminant validity. Cronbach's alpha of 0.93 in the Spanish adaptation and excellent convergent and discriminant validity. It consists of 5 items that are scored on a scale of 0 to 4. It is calculated by adding the score of the 5 items and the maximum score is 20. | immediately pre-treatment, weekly during treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment | 
| Change in the Positive and Negative Affect Schedule (PANAS) validated in the Spanish population | It is a self-applied instrument to assess two independent dimensions of affectivity: Positive Affect (PA) and Negative Affect (NA). Psychometric properties; excellent internal consistency in the original version (α = 0.84 to 0.90) and convergent and discriminant validity. Excellent internal consistency in the Spanish adaptation (α =0.87 to 0.91). It consists of 20 items that are scored on a 1-5 scale. It has two subscales: positive affect (10 items) and negative affect (10 items). It is calculated by adding each of the items on the two scales separately. The maximum score is 50 for each of the subscales. | immediately pre-treatment, weekly during treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment | 
| Change in the Quality of Life Index (QLI) validated in Spanish language | It is a self-applied instrument to assess health-rated quality of life. Psychometric properties; high test-retest reliability (r = .87) and internal consistency (α = .92) in the original version and good test-retest reliability and internal consistency (α = 0.87) in the Spanish language adaptation. It consists of 10 items that assess a global perception of quality of life and aspects ranging from physical well-being to spiritual fulfillment. A 10-point Likert scale is used to measure satisfaction in each area. | immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment | 
| Change in the Work and Social Adjustment Scale (WSAS) validated in Spanish language | It is a self-applied instrument to assess psychosocial functional impairment. Psychometric properties; good to excellent test-retest reliability, sensitivity to change and internal consistency (α = 0.70 to 0.94) in the original version. Good concurrent validity and excellent internal consistency in the Spanish version. It consists of 5 items that are scored on a scale of 0 (not at all) to 8 (very severely). It is calculated adding the score of all the items and the maximum total score is 40. Higher scores indicate greater interference in different areas. | immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment | 
| Change in the Posttraumatic Growth Inventory (PTGI) validated in Spanish language | It is a self-applied instrument to assess post-trauma growth and self-improvement. Psychometric properties; excellent internal consistency (α = 0.90) and acceptable test-retest reliability (around 0.71) in the original version and excellent internal consistency (α = 0.92) in the Spanish version. Is a 21-item scale built on the five-factor model (Factors: Relating to Others, New Possibilities, Personal Strength, Spiritual Enhancement, Appreciation). A 6-point likert scale is used for each item. A summation of the scores indicates the level of post-traumatic growth. Higher score indicates greater positive transformation. | immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment | 
| Change in Five-Facet Mindfulness Questionnaire (FFMQ-15) validated in Spanish population | It is a short form of the 39-item FFMQ (Baer et al., 2006), self-applied instrument to assess the ability to be aware in the experience of the moment. It is a 15-item scale with a Likert response format ranging from 1 (never or very rarely true) to 5 (very often or always true). It evaluates five facets of mindfulness (Observing, Describing, Acting with awareness, Non judging internal experience, Non reactivity to internal experience). Higher scores represent higher dispositional mindfulness. Psychometric properties; Good internal consistency is shown on all 5 scales. | immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment | 
| Change in Self-Compassion Scale Short Form (SCS-SF) validated in Spanish population | It is a self-applied instrument to assess the capacity for self-compassion. Psychometric properties; good internal consistency (α = 0.86) and high correlation with the long version of the SCS (r = 0.97) in the original validation and good internal consistency (α = 0.85) and high test-retest reliability in the Spanish version. To calculate the total self-compassion score, a total mean is calculated considering the inverse items. Subscale scores are computed by calculating the mean of subscale item responses. | immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment | 
| Change in Typical Beliefs Questionnaire (TBQ) | It is a self-applied instrument to assess maladaptive thinking common in people with complicated grief. Psychometric properties; good internal consistency for the general scale (α = 0.83) and good test-retest reliability. Ii is a 25-item scale which measures the degree of agreement regarding different statements with a Likert response format ranging from 0 (not at all) to 4 (very strongly). Five-factor structure (protesting the death, negative thoughts about the world, needing the person, less grief is wrong and grieving too much). The maximum score is 100. The scores of the subscale are obtained from the sum of the elements of each factor. | immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment | 
| Change in Purpose-In-Life Test (PIL- 10) | It is a short form of the 20-items Purpose-In-Life Test (Crumbaugh, 1968). Is a self-applied instrument to assess the personal experience of meaning of life (satisfaction and meaning of life and vital goals and purposes). Psychometric properties; good internal consistency (α = 0.86). The total score is obtained by adding the values of the selected answer options and the maximum score is 70. Two- factor structure (satisfaction and meaning of life; vital goals and purposes). | immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment |