<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04462146</url>
  </required_header>
  <id_info>
    <org_study_id>z7dqxrg8</org_study_id>
    <nct_id>NCT04462146</nct_id>
  </id_info>
  <brief_title>An Internet-based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)</brief_title>
  <acronym>GROw</acronym>
  <official_title>Internet-based Self Applied Treatment Program for Prolonged Grief Disorder (PGD): An Open Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitat Jaume I</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitat Jaume I</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the feasibility, acceptability and preliminary&#xD;
      efficacy of an internet delivered cognitive behavior treatment (ICBT) for people with&#xD;
      prolonged grief disorder (PGD) compared to a face-to-face intervention for PGD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Grief is an intense emotional reaction to the loss of a loved one. It produces feelings of&#xD;
      regret and longing that usually decrease over time. However, some people have difficulty&#xD;
      adapting to the loss and develop Prolonged Grief Disorder (PGD). An open clinical trial will&#xD;
      be conducted to investigate the feasibility [initial efficacy and acceptability] of an&#xD;
      Internet delivered cognitive behavior treatment (ICBT) for adult people diagnosed with&#xD;
      prolonged grief disorder (PGD). There will be at least 24 participants that will be randomly&#xD;
      assigned to experimental group (internet-based treatment for PGD) or active control group&#xD;
      (traditional face- to-face intervention for PGD). Four assessment moments will be included&#xD;
      (pre-treatment, post-treatment, 3 months follow-up and 12 months follow-up). The present&#xD;
      study aims to improve knowledge about the feasibility, acceptability and preliminary efficacy&#xD;
      of an ICBT for PGD and conduct a preliminary comparison between two intervention conditions&#xD;
      (internet-based intervention vs. traditional face-to-face intervention). Also, the&#xD;
      investigators aim to collect information that can help to improve the efficacy and&#xD;
      acceptability of Internet-based interventions in general.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2021</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the Inventory of Complicated Grief (ICG) validated in the Spanish population</measure>
    <time_frame>immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment</time_frame>
    <description>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.&#xD;
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.&#xD;
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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Beck Depression Inventory - Second Edition validated in the Spanish population</measure>
    <time_frame>immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the Overall Anxiety Severity and Impairment Scale (OASIS) validated in the Spanish population</measure>
    <time_frame>immediately pre-treatment, weekly during treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Overall Depression Severity and Impairment Scale (ODSIS) validated in the Spanish population</measure>
    <time_frame>immediately pre-treatment, weekly during treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment</time_frame>
    <description>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.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Positive and Negative Affect Schedule (PANAS) validated in the Spanish population</measure>
    <time_frame>immediately pre-treatment, weekly during treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Quality of Life Index (QLI) validated in Spanish language</measure>
    <time_frame>immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Work and Social Adjustment Scale (WSAS) validated in Spanish language</measure>
    <time_frame>immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Posttraumatic Growth Inventory (PTGI) validated in Spanish language</measure>
    <time_frame>immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Five-Facet Mindfulness Questionnaire (FFMQ-15) validated in Spanish population</measure>
    <time_frame>immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment</time_frame>
    <description>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.&#xD;
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.&#xD;
Psychometric properties; Good internal consistency is shown on all 5 scales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-Compassion Scale Short Form (SCS-SF) validated in Spanish population</measure>
    <time_frame>immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment</time_frame>
    <description>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.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Typical Beliefs Questionnaire (TBQ)</measure>
    <time_frame>immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment</time_frame>
    <description>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.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Purpose-In-Life Test (PIL- 10)</measure>
    <time_frame>immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment</time_frame>
    <description>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).&#xD;
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).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Prolonged Grief Disorder-13 (PG-13) validated in Spanish population</measure>
    <time_frame>immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment</time_frame>
    <description>It is a self-applied instrument to assess prolonged grief in people who have lost a loved one six or more months ago.&#xD;
Psychometric properties; reliability test-retest Kappa coefficient = 1 and Cronbach's alpha = 0.92 in the Spanish adaptation.&#xD;
13-item scale grouped into 5 criteria (loss of a loved one, symptoms of intense separation anxiety, duration, cognitive, emotional or behavioral symptoms and functional impairment). Items valued differently according to criteria; Likert-type scale of five responses from 1 (absence of that symptom) to 5 (highest intensity) and dichotomous answer (yes / no). Needed to meet the five criteria to consider prolonged grief.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in ADIS Clinician's severity rating scale</measure>
    <time_frame>immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment</time_frame>
    <description>Indicate the level of distress-interference in functioning. 1 item (from 0/&quot;Absent&quot; to 8/&quot;Very severely disturbing/ disabling&quot;) assessed by the therapist.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in The Structured Clinical Interview for Complicated Grief (SCI-CG)</measure>
    <time_frame>immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment</time_frame>
    <description>It is an interview with 31 items that evaluates symptoms of prolonged grief in people who have lost a loved one six or more months ago the interview.&#xD;
Psychometric properties; acceptable internal consistency (α = 0.86) excellent inter-rater reliability and good test-retest reliability.&#xD;
Each item is answered on a 3-point likert scale (Not present, insecure or misleading and present). It is calculated by adding the scores of each item and the highest score is 93.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Expectations and satisfaction Questionnaire</measure>
    <time_frame>immediately pre-treatment, immediately post-treatment</time_frame>
    <description>It is a self-applied instrument Adapted from Borkovec &amp; Nau (1972) to assess participants' expectations (before the intervention) and satisfaction with the treatment (after the intervention).&#xD;
Evaluates the logic of the intervention, satisfaction with the intervention, recommendation of the intervention to others, utility of the intervention for other psychological problems, utility of the intervention for that condition and aversion generated by the intervention. Items are scored on 0-10 scales (0 =&quot;not at all&quot;; 10 = &quot;a lot&quot;). Higher score indicates greater expectation towards treatment and satisfaction with the intervention.</description>
  </other_outcome>
  <other_outcome>
    <measure>Qualitative opinion interview</measure>
    <time_frame>immediately post-treatment</time_frame>
    <description>Perceived clinical utility of each part of the treatment (0 = no useful at all; 10 = maximum utility)&#xD;
Utility images, video, audio and written content (0 = no useful at all; 10 = maximum utility)&#xD;
Utility, satisfaction and help in the adherence of the weekly call (only in internet-based condition group)</description>
  </other_outcome>
  <other_outcome>
    <measure>Preference scale</measure>
    <time_frame>immediately pre-treatment, immediately post-treatment</time_frame>
    <description>It is a 7-item scale developed specifically for this study, which evaluates the preferences of the participants on the two treatment conditions (face-to-face and internet-based intervention).&#xD;
The 7 items measure general preference, utility, logic and aversiveness of the treatment and recommendation of the intervention to others. The answer to each item is dichotomous: A) self-applied via the Internet (with a short weekly phone call from a therapist); B) Applied weekly face-to-face sessions of approximately 60 minutes, and carried out by a therapist.</description>
  </other_outcome>
  <other_outcome>
    <measure>Usability and Acceptance Questionnaire</measure>
    <time_frame>immediately post-treatment</time_frame>
    <description>It is a 11-item questionnaire to assess the usability and acceptance of the technology by the patient.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Prolonged Grief Disorder</condition>
  <arm_group>
    <arm_group_label>Internet-based intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Face-to-face treatment by videoconference</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Internet-based Self Applied Treatment Program</intervention_name>
    <description>It is a self-applied treatment for PGD through the web &quot;psicologíaytecnología.labpsitec.es&quot;. 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</description>
    <arm_group_label>Internet-based intervention</arm_group_label>
    <other_name>GROw</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Videoconference treatment with a therapist</intervention_name>
    <description>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.&#xD;
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.</description>
    <arm_group_label>Face-to-face treatment by videoconference</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Meeting diagnostic criteria for PGD&#xD;
&#xD;
          -  Sign an informed consent&#xD;
&#xD;
          -  Ability to understand and read Spanish&#xD;
&#xD;
          -  Ability to use a computer and having access to the Internet&#xD;
&#xD;
          -  Having an e-mail address&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of risk of suicide or self-destructive behaviors&#xD;
&#xD;
          -  Presence of another severe mental disorder (substance abuse or dependence, psychotic&#xD;
             disorder, dementia o bipolar disorder)&#xD;
&#xD;
          -  Presence of severe personality disorder&#xD;
&#xD;
          -  Presence of a medical condition whose severity or characteristics prevent the&#xD;
             performance of treatment&#xD;
&#xD;
          -  Receiving other psychological treatment during the study for PGD&#xD;
&#xD;
          -  An increase and/or change in the medication during the study period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Soledad Quero, psychology</last_name>
    <role>Study Director</role>
    <affiliation>Universitat Jaume I</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Daniel Campos, psychology</last_name>
    <role>Study Director</role>
    <affiliation>Universitat Jaume I</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cintia Tur, psychology</last_name>
    <role>Study Chair</role>
    <affiliation>Universitat Jaume I</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Soledad Quero, psychology</last_name>
    <phone>+34 96 438 76 41</phone>
    <email>squero@uji.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Universitat Jaume I</name>
      <address>
        <city>Castellón de la Plana</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Soledad Quero</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>https://icd.who.int/browse11/l-m/en</url>
    <description>International Classification of Diseases 11th Revision</description>
  </link>
  <reference>
    <citation>Mauro C, Reynolds CF, Maercker A, Skritskaya N, Simon N, Zisook S, Lebowitz B, Cozza SJ, Shear MK. Prolonged grief disorder: clinical utility of ICD-11 diagnostic guidelines. Psychol Med. 2019 Apr;49(5):861-867. doi: 10.1017/S0033291718001563. Epub 2018 Jun 18.</citation>
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  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>October 21, 2021</last_update_submitted>
  <last_update_submitted_qc>October 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04462146
org study id: z7dqxrg8
nct id: NCT04462146
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in the Inventory of Complicated Grief (ICG) validated in the Spanish population
time frame: immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment
description: 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.
measure: Change in the Beck Depression Inventory - Second Edition validated in the Spanish population
time frame: immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment
description: 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.
measure: Change in the Overall Anxiety Severity and Impairment Scale (OASIS) validated in the Spanish population
time frame: immediately pre-treatment, weekly during treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment
description: 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.
measure: Change in the Overall Depression Severity and Impairment Scale (ODSIS) validated in the Spanish population
time frame: immediately pre-treatment, weekly during treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment
description: 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.
measure: Change in the Positive and Negative Affect Schedule (PANAS) validated in the Spanish population
time frame: immediately pre-treatment, weekly during treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment
description: 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.
measure: Change in the Quality of Life Index (QLI) validated in Spanish language
time frame: immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment
description: 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.
measure: Change in the Work and Social Adjustment Scale (WSAS) validated in Spanish language
time frame: immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment
description: 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.
measure: Change in the Posttraumatic Growth Inventory (PTGI) validated in Spanish language
time frame: immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment
description: 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.
measure: Change in Five-Facet Mindfulness Questionnaire (FFMQ-15) validated in Spanish population
time frame: immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment
description: 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.
measure: Change in Self-Compassion Scale Short Form (SCS-SF) validated in Spanish population
time frame: immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment
description: 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.
measure: Change in Typical Beliefs Questionnaire (TBQ)
time frame: immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment
description: 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.
measure: Change in Purpose-In-Life Test (PIL- 10)
time frame: immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment
description: 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).
measure: Change in Prolonged Grief Disorder-13 (PG-13) validated in Spanish population
time frame: immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment
description: It is a self-applied instrument to assess prolonged grief in people who have lost a loved one six or more months ago.
Psychometric properties; reliability test-retest Kappa coefficient = 1 and Cronbach's alpha = 0.92 in the Spanish adaptation.
13-item scale grouped into 5 criteria (loss of a loved one, symptoms of intense separation anxiety, duration, cognitive, emotional or behavioral symptoms and functional impairment). Items valued differently according to criteria; Likert-type scale of five responses from 1 (absence of that symptom) to 5 (highest intensity) and dichotomous answer (yes / no). Needed to meet the five criteria to consider prolonged grief.
measure: Change in ADIS Clinician's severity rating scale
time frame: immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment
description: Indicate the level of distress-interference in functioning. 1 item (from 0/"Absent" to 8/"Very severely disturbing/ disabling") assessed by the therapist.
measure: Change in The Structured Clinical Interview for Complicated Grief (SCI-CG)
time frame: immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment
description: It is an interview with 31 items that evaluates symptoms of prolonged grief in people who have lost a loved one six or more months ago the interview.
Psychometric properties; acceptable internal consistency (α = 0.86) excellent inter-rater reliability and good test-retest reliability.
Each item is answered on a 3-point likert scale (Not present, insecure or misleading and present). It is calculated by adding the scores of each item and the highest score is 93.
measure: Change in Expectations and satisfaction Questionnaire
time frame: immediately pre-treatment, immediately post-treatment
description: It is a self-applied instrument Adapted from Borkovec & Nau (1972) to assess participants' expectations (before the intervention) and satisfaction with the treatment (after the intervention).
Evaluates the logic of the intervention, satisfaction with the intervention, recommendation of the intervention to others, utility of the intervention for other psychological problems, utility of the intervention for that condition and aversion generated by the intervention. Items are scored on 0-10 scales (0 ="not at all"; 10 = "a lot"). Higher score indicates greater expectation towards treatment and satisfaction with the intervention.
measure: Qualitative opinion interview
time frame: immediately post-treatment
description: Perceived clinical utility of each part of the treatment (0 = no useful at all; 10 = maximum utility)
Utility images, video, audio and written content (0 = no useful at all; 10 = maximum utility)
Utility, satisfaction and help in the adherence of the weekly call (only in internet-based condition group)
measure: Preference scale
time frame: immediately pre-treatment, immediately post-treatment
description: It is a 7-item scale developed specifically for this study, which evaluates the preferences of the participants on the two treatment conditions (face-to-face and internet-based intervention).
The 7 items measure general preference, utility, logic and aversiveness of the treatment and recommendation of the intervention to others. The answer to each item is dichotomous: A) self-applied via the Internet (with a short weekly phone call from a therapist); B) Applied weekly face-to-face sessions of approximately 60 minutes, and carried out by a therapist.
measure: Usability and Acceptance Questionnaire
time frame: immediately post-treatment
description: It is a 11-item questionnaire to assess the usability and acceptance of the technology by the patient.
arm group label: Internet-based intervention
arm group type: Experimental
description: 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.
arm group label: Face-to-face treatment by videoconference
arm group type: Active Comparator
description: 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.
intervention type: Behavioral
intervention name: Internet-based Self Applied Treatment Program
description: 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
arm group label: Internet-based intervention
other name: GROw
intervention type: Behavioral
intervention name: Videoconference treatment with a therapist
description: 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.
arm group label: Face-to-face treatment by videoconference
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Soledad Quero, psychology
role: Study Director
affiliation: Universitat Jaume I
last name: Daniel Campos, psychology
role: Study Director
affiliation: Universitat Jaume I
last name: Cintia Tur, psychology
role: Study Chair
affiliation: Universitat Jaume I
last name: Soledad Quero, psychology
phone: +34 96 438 76 41
email: squero@uji.es
facility: 
status: Recruiting
contact: 
country: Spain
url: https://icd.who.int/browse11/l-m/en
description: International Classification of Diseases 11th Revision
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