Prolonged Grief DisorderGROwNCT04462146
An Internet-based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)
A study testing Internet-based Self Applied Treatment Program and Videoconference treatment with a therapist in people with Prolonged Grief Disorder, run by Universitat Jaume I at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prolonged Grief Disorder
- What is being tested?
- Internet-based Self Applied Treatment Program and Videoconference treatment with a therapist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-based Self Applied Treatment Program for Prolonged Grief Disorder (PGD): An Open Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Prolonged Grief Disorder
- Being tested
- Internet-based Self Applied Treatment Program, Videoconference treatment with a therapist
- Medical subject headings
- Prolonged Grief Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based Self Applied Treatment ProgramBehavioural
Also called GROw
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
Videoconference treatment with a therapistBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based intervention | Experimental | 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. Receives: Behavioral: Internet-based Self Applied Treatment Program |
| Face-to-face treatment by videoconference | Active comparator | 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. Receives: Behavioral: Videoconference treatment with a therapist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start1 Feb 2021
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Prolonged Grief DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soledad Quero, psychology, Study director, Universitat Jaume IDaniel Campos, psychology, Study director, Universitat Jaume ICintia Tur, psychology, Study chair, Universitat Jaume I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462146
- Sponsor's protocol ID
- z7dqxrg8
- Acronym
- GROw
- Status last verified
- Oct 2021
- First submitted
- 17 Jun 2020
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29909789Prigerson HG, Horowitz MJ, Jacobs SC, Parkes CM, Aslan M, Goodkin K, Raphael B, Marwit SJ, Wortman C, Neimeyer RA, Bonanno GA, Block SD, Kissane D, Boelen P, Maercker A, Litz BT, Johnson JG, First MB, Maciejewski PK. Prolonged grief disorder: Psychometric validation of criteria proposed for DSM-V and ICD-11. PLoS Med. 2009 Aug;6(8):e1000121. doi: 10.1371/journal.pmed.1000121. Epub 2009 Aug 4.
PubMed 19652695Estevan, P., del Miguel, C., Prigerson, H., García-García, JA., del Cura, & GEDUPROL. (2019). Adaptación trascultural y validación del cuestionario PG-13 para la detección precoz de duelo prolongado. Psicooncología, 14(1), 163-164. https://doi.org/10.5209/PSIC.55820
Bui E, Mauro C, Robinaugh DJ, Skritskaya NA, Wang Y, Gribbin C, Ghesquiere A, Horenstein A, Duan N, Reynolds C, Zisook S, Simon NM, Shear MK. THE STRUCTURED CLINICAL INTERVIEW FOR COMPLICATED GRIEF: RELIABILITY, VALIDITY, AND EXPLORATORY FACTOR ANALYSIS. Depress Anxiety. 2015 Jul;32(7):485-92. doi: 10.1002/da.22385. Epub 2015 Jun 9.
PubMed 26061724Prigerson HG, Maciejewski PK, Reynolds CF 3rd, Bierhals AJ, Newsom JT, Fasiczka A, Frank E, Doman J, Miller M. Inventory of Complicated Grief: a scale to measure maladaptive symptoms of loss. Psychiatry Res. 1995 Nov 29;59(1-2):65-79. doi: 10.1016/0165-1781(95)02757-2.
PubMed 8771222Limonero Garcia, J., Lacasta Reverte, M., Garcia Garcia, J., Mate Mendez, J., & Prigerson, H. (2009). Adaptación al castellano del inventario de duelo complicado. Medicina Paliativa, 16(5), 291-297.
Beck, A.T., Steer, R.A., y Brown, G.K. (1996). Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation.
Sanz, J., Navarro, M. E., y Vázquez, C. (2003). Adaptación española del Inventario para la Depresión de Beck-II (BDI-II): 1. Propiedades psicométricas en estudiantes universitarios. Análisis y Modificación de Conducta, 29, 239-288.
Campbell-Sills L, Norman SB, Craske MG, Sullivan G, Lang AJ, Chavira DA, Bystritsky A, Sherbourne C, Roy-Byrne P, Stein MB. Validation of a brief measure of anxiety-related severity and impairment: the Overall Anxiety Severity and Impairment Scale (OASIS). J Affect Disord. 2009 Jan;112(1-3):92-101. doi: 10.1016/j.jad.2008.03.014. Epub 2008 May 16.
PubMed 18486238Gonzalez-Robles A, Mira A, Miguel C, Molinari G, Diaz-Garcia A, Garcia-Palacios A, Breton-Lopez JM, Quero S, Banos RM, Botella C. A brief online transdiagnostic measure: Psychometric properties of the Overall Anxiety Severity and Impairment Scale (OASIS) among Spanish patients with emotional disorders. PLoS One. 2018 Nov 1;13(11):e0206516. doi: 10.1371/journal.pone.0206516. eCollection 2018.
PubMed 30383797Bentley KH, Gallagher MW, Carl JR, Barlow DH. Development and validation of the Overall Depression Severity and Impairment Scale. Psychol Assess. 2014 Sep;26(3):815-830. doi: 10.1037/a0036216. Epub 2014 Apr 7.
PubMed 24708078Mira A, Gonzalez-Robles A, Molinari G, Miguel C, Diaz-Garcia A, Breton-Lopez J, Garcia-Palacios A, Quero S, Banos R, Botella C. Capturing the Severity and Impairment Associated With Depression: The Overall Depression Severity and Impairment Scale (ODSIS) Validation in a Spanish Clinical Sample. Front Psychiatry. 2019 Apr 9;10:180. doi: 10.3389/fpsyt.2019.00180. eCollection 2019.
PubMed 31024352Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
PubMed 3397865Diaz-Garcia A, Gonzalez-Robles A, Mor S, Mira A, Quero S, Garcia-Palacios A, Banos RM, Botella C. Positive and Negative Affect Schedule (PANAS): psychometric properties of the online Spanish version in a clinical sample with emotional disorders. BMC Psychiatry. 2020 Feb 10;20(1):56. doi: 10.1186/s12888-020-2472-1.
PubMed 32039720Tedeschi RG, Calhoun LG. The Posttraumatic Growth Inventory: measuring the positive legacy of trauma. J Trauma Stress. 1996 Jul;9(3):455-71. doi: 10.1007/BF02103658.
PubMed 8827649
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Self Applied Treatment Program for Prolonged Grief Disorder (PGD): An Open Clinical Trial
- ClinicalTrials.gov ID
- NCT04462146
- Acronym / sponsor ID
- GROw / z7dqxrg8
- Conditions
- Prolonged Grief Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based intervention | Experimental | Behavioral: Internet-based Self Applied Treatment ProgramInternet-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. |
| Face-to-face treatment by videoconference | Active comparator | Behavioral: Videoconference treatment with a therapistFace-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based Self Applied Treatment ProgramAlso: GROwIt 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 | Behavioural | Internet-based intervention |
| Videoconference treatment with a therapistIt 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. | Behavioural | Face-to-face treatment by videoconference |
Primary outcome
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
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.
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
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.
10 secondary outcomes
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
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
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
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
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
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
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
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
Change in Typical Beliefs Questionnaire (TBQ)
Time frame: immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment
Change in Purpose-In-Life Test (PIL- 10)
Time frame: immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Background: PubMed 29909789Mauro 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.
- Background: PubMed 19652695Prigerson HG, Horowitz MJ, Jacobs SC, Parkes CM, Aslan M, Goodkin K, Raphael B, Marwit SJ, Wortman C, Neimeyer RA, Bonanno GA, Block SD, Kissane D, Boelen P, Maercker A, Litz BT, Johnson JG, First MB, Maciejewski PK. Prolonged grief disorder: Psychometric validation of criteria proposed for DSM-V and ICD-11. PLoS Med. 2009 Aug;6(8):e1000121. doi: 10.1371/journal.pmed.1000121. Epub 2009 Aug 4.
- BackgroundEstevan, P., del Miguel, C., Prigerson, H., García-García, JA., del Cura, & GEDUPROL. (2019). Adaptación trascultural y validación del cuestionario PG-13 para la detección precoz de duelo prolongado. Psicooncología, 14(1), 163-164. https://doi.org/10.5209/PSIC.55820
- Background: PubMed 26061724Bui E, Mauro C, Robinaugh DJ, Skritskaya NA, Wang Y, Gribbin C, Ghesquiere A, Horenstein A, Duan N, Reynolds C, Zisook S, Simon NM, Shear MK. THE STRUCTURED CLINICAL INTERVIEW FOR COMPLICATED GRIEF: RELIABILITY, VALIDITY, AND EXPLORATORY FACTOR ANALYSIS. Depress Anxiety. 2015 Jul;32(7):485-92. doi: 10.1002/da.22385. Epub 2015 Jun 9.
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- International Classification of Diseases 11th RevisionLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soledad Quero, psychology study director
Universitat Jaume I
Daniel Campos, psychology study director
Universitat Jaume I
Cintia Tur, psychology study chair
Universitat Jaume I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based Self Applied Treatment Program and Videoconference treatment with a therapist in people with Prolonged Grief Disorder, run by Universitat Jaume I at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soledad Quero, psychology (+34 96 438 76 41, squero@uji.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04462146, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.