GriefPGDNCT04376385
An Internet-based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)
A study testing GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (PGD) in people with Grief, run by Universitat Jaume I at 1 site in Spain.
Trial summary
The purpose os this study is examine the effect and feasibility (usability and satisfaction) of an iCBT (GROw program) for adults with PGD Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Grief
- What is being tested?
- GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2020to 1 Oct 2021
- 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 criterio for PGD
- Sign an informed consent
- Ability to understand and read Spanish
- Abilitiy 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, pshychotic 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: An Internet-based Self Applied Treatment Program for Prolonged Grief Disorder (PGD): A Multiple-baseline Case Series Study
The purpose os this study is examine the effect and feasibility (usability and satisfaction) of an iCBT (GROw program) for adults with PGD
Read the detailed description
The death of a loved one has physical, psychological, and social consequences. Between 9.8 and 21.5% of people who lose a loved one develop Prolonged Grief Disorder (PGD). Internet- and computer-based interventions (i.e., Internet-delivered Cognitive-Behavioral Therapy, iCBT) are cost-effective and scalable alternatives that make it possible to reach more people with PGD. The main goal of the present investigation was to examine the effect and feasibility (usability and satisfaction) of an iCBT (GROw program) for adults with PGD. A secondary objective was to detect adherence to the app (Emotional Monitor) used to measure daily grief symptoms. The study had a single-case multiple-baseline AB design with six participants. The GROw program is organized sequentially in eight modules, and it is based on the dual-process model of coping with bereavement. Evaluations included a pre-to-post treatment assessment of depression, grief symptoms, and typical grief beliefs, along with daily measures of symptom frequency and intensity on the Emotional Monitor App. Treatment opinions and adherence to the App were also collected. Efficacy data were calculated using a Nonoverlap of All Pairs (NAP) analysis and Reliable Change Index (RCI).
- Conditions
- Grief
- Being tested
- GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)Behavioural
It is a self-applied treatment 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 8-10 weeks. A support call will be made a week (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
| Study group | Role | What they receive |
|---|---|---|
| Treatment condition - 9 days wait | 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: GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (PGD) |
| Treatment condition - 12 days wait | 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: GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (PGD) |
| Treatment condition - 17 days wait | 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: GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (PGD) |
| Treatment condition - 19 days wait | 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: GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (PGD) |
| Treatment condition - 33 days wait | 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: GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (PGD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Emotional Pain: intensity of sadness, anger, anxiety, guilt and grief
- Evaluation from mobile app
Item 1: In relation to the death of your loved one; What intensity of sadness have you felt TODAY? Item2: In relation to the death of your loved one; What intensity of anger have you felt TODAY? Item 3: In relation to the death of your loved one; What intensity of anxiety have you felt TODAY? Item 4: In relation to the death of your loved one; What intensity of guilt have you felt TODAY? Item 5: In relation to the death of your loved one; What intensity of pain from loss have you felt TODAY?
- Evaluation from mobile app
Measured: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment
Secondary outcomes (9)
Change in frequency of sad memories
Item: How often have you remembered TODAY the absence of your loved one with enormous and deep sadness?
- Evaluation from mobile app
Measured: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment
Change in frequency of memories that produce anger
Item: How often have you remembered TODAY the absence of your loved one with a huge and deep anger?
- Evaluation from mobile app
Measured: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment
Change in frequency of memories that produce anxiety
Item: How often have you remembered TODAY the absence of your loved one with enormous and deep anxiety?
- Evaluation from mobile app
Measured: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment
Change in frequency of memories that produce guilt
Item: How often have you remembered TODAY the absence of your loved one with a huge and deep guilt?
- Evaluation from mobile app
Measured: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment
Change in frequency of pleasant memories
Item: How often have you had pleasant memories with your loved one TODAY?
- Evaluation from mobile app
Measured: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment
Change in emotion avoidance frequency
Item: How often have you wished TODAY to get rid of your unpleasant emotions related to your loved one?
- Evaluation from mobile app
Measured: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment
Change in thoughts avoidance frequency
Item: How often have you tried TODAY to get rid of unpleasant thoughts related to your loved one?
- Evaluation from mobile app
Measured: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment
Change in difficulty accepting the death
Item: How often have you thought TODAY that you cannot believe that your beloved family has died?
- Evaluation from mobile app
Measured: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment
Change in difficulty accepting the death
Item: How often have you wished TODAY intensely that your loved one was with you?
Measured: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 Nov 2020
- Primary completion1 May 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GriefStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376385
- Sponsor's protocol ID
- z7dqxrg7
- Acronym
- PGD
- Status last verified
- Feb 2022
- First submitted
- 23 Mar 2020
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Internet-based Self Applied Treatment Program for Prolonged Grief Disorder (PGD): A Multiple-baseline Case Series Study
- ClinicalTrials.gov ID
- NCT04376385
- Acronym / sponsor ID
- PGD / z7dqxrg7
- Conditions
- Grief
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 6 May 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 os this study is examine the effect and feasibility (usability and satisfaction) of an iCBT (GROw program) for adults with PGD
Detailed description
The death of a loved one has physical, psychological, and social consequences. Between 9.8 and 21.5% of people who lose a loved one develop Prolonged Grief Disorder (PGD). Internet- and computer-based interventions (i.e., Internet-delivered Cognitive-Behavioral Therapy, iCBT) are cost-effective and scalable alternatives that make it possible to reach more people with PGD. The main goal of the present investigation was to examine the effect and feasibility (usability and satisfaction) of an iCBT (GROw program) for adults with PGD. A secondary objective was to detect adherence to the app (Emotional Monitor) used to measure daily grief symptoms. The study had a single-case multiple-baseline AB design with six participants. The GROw program is organized sequentially in eight modules, and it is based on the dual-process model of coping with bereavement. Evaluations included a pre-to-post treatment assessment of depression, grief symptoms, and typical grief beliefs, along with daily measures of symptom frequency and intensity on the Emotional Monitor App. Treatment opinions and adherence to the App were also collected. Efficacy data were calculated using a Nonoverlap of All Pairs (NAP) analysis and Reliable Change Index (RCI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment condition - 9 days wait | Experimental | Behavioral: GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)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 |
| Treatment condition - 12 days wait | Experimental | Behavioral: GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)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 |
| Treatment condition - 17 days wait | Experimental | Behavioral: GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)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 |
| Treatment condition - 19 days wait | Experimental | Behavioral: GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)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 |
| Treatment condition - 33 days wait | Experimental | Behavioral: GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)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 |
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 criterio for PGD
- Sign an informed consent
- Ability to understand and read Spanish
- Abilitiy 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, pshychotic 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 |
|---|---|---|
| GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)It is a self-applied treatment 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 8-10 weeks. A support call will be made a week (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 | Treatment condition - 12 days wait, Treatment condition - 17 days wait, Treatment condition - 19 days wait, Treatment condition - 33 days wait, Treatment condition - 9 days wait |
Primary outcome
Change in Emotional Pain: intensity of sadness, anger, anxiety, guilt and grief
Time frame: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment
* Evaluation from mobile app Item 1: In relation to the death of your loved one; What intensity of sadness have you felt TODAY? Item2: In relation to the death of your loved one; What intensity of anger have you felt TODAY? Item 3: In relation to the death of your loved one; What intensity of anxiety have you felt TODAY? Item 4: In relation to the death of your loved one; What intensity of guilt have you felt TODAY? Item 5: In relation to the death of your loved one; What intensity of pain from loss have you felt TODAY? * Evaluation from mobile app
9 secondary outcomes
Change in frequency of sad memories
Time frame: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment
Change in frequency of memories that produce anger
Time frame: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment
Change in frequency of memories that produce anxiety
Time frame: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment
Change in frequency of memories that produce guilt
Time frame: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment
Change in frequency of pleasant memories
Time frame: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment
Change in emotion avoidance frequency
Time frame: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment
Change in thoughts avoidance frequency
Time frame: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment
Change in difficulty accepting the death
Time frame: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment
Change in difficulty accepting the death
Time frame: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (PGD) in people with Grief, 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: finished, as of the sponsor's last update on 28 Feb 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Emotional Pain: intensity of sadness, anger, anxiety, guilt and grief (time frame: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2022.