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

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

Study Overview

• Status: Completed
• Conditions: Grief
• Intervention / Treatment: Behavioral: GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Castellón
    • Castellón de la Plana, Castellón, Spain, 12071
      • Universitat Jaume I

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment condition - 9 days wait; Internet-based Self Applied Treatment Program. Main components: Motivation for change, Psychoeducation, Behavioral activation, Exposure, Mindfulness and compassion strategies, integration of loss, restoration and reconstruction of meaning, Cognitive reappraisal and Relapse prevention	Behavioral: 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
Experimental: Treatment condition - 12 days wait; Internet-based Self Applied Treatment Program. Main components: Motivation for change, Psychoeducation, Behavioral activation, Exposure, Mindfulness and compassion strategies, integration of loss, restoration and reconstruction of meaning, Cognitive reappraisal and Relapse prevention	Behavioral: 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
Experimental: Treatment condition - 17 days wait; Internet-based Self Applied Treatment Program. Main components: Motivation for change, Psychoeducation, Behavioral activation, Exposure, Mindfulness and compassion strategies, integration of loss, restoration and reconstruction of meaning, Cognitive reappraisal and Relapse prevention	Behavioral: 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
Experimental: Treatment condition - 19 days wait; Internet-based Self Applied Treatment Program. Main components: Motivation for change, Psychoeducation, Behavioral activation, Exposure, Mindfulness and compassion strategies, integration of loss, restoration and reconstruction of meaning, Cognitive reappraisal and Relapse prevention	Behavioral: 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
Experimental: Treatment condition - 33 days wait; Internet-based Self Applied Treatment Program. Main components: Motivation for change, Psychoeducation, Behavioral activation, Exposure, Mindfulness and compassion strategies, integration of loss, restoration and reconstruction of meaning, Cognitive reappraisal and Relapse prevention	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	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?	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with the treatment	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	At the end of the treatment
Change in Prolonged Grief Disorder-13 (PG-13)	Diagnostic measure. Detects prolonged grief in people who have lost a loved one. Self-administered. Duration: 10 minutes approx. Composed of 13 items. Good psychometric properties (reliability test retest Kappa coefficient = 1; Cronbach's alpha = 0.92)	Before and after treatment, at 3 and 12 months
Change in ADIS Clinician's severity rating scale	Indicate the level of distress-interference in functioning. 1 item (from 0/"Absent" to 8/"Very severely disturbing/disabling") completed by the therapist.	Before and after treatment, at 3 and 12 months

Collaborators and Investigators

• Sponsor: Universitat Jaume I

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: z7dqxrg7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No