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Completed

NCT Number: NCT04376385

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

The purpose os this study is examine the effect and feasibility (usability and satisfaction) of an iCBT (GROw program) for adults with PGD

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Key information

Conditions

Grief

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitat Jaume I

Castellon, Castellón, 12071, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    Item: How often have you remembered TODAY the absence of your loved one with enormous and deep sadness?

    • Evaluation from mobile app

  2. 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

    Item: How often have you remembered TODAY the absence of your loved one with a huge and deep anger?

    • Evaluation from mobile app

  3. 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

    Item: How often have you remembered TODAY the absence of your loved one with enormous and deep anxiety?

    • Evaluation from mobile app

  4. 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

    Item: How often have you remembered TODAY the absence of your loved one with a huge and deep guilt?

    • Evaluation from mobile app

  5. 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

    Item: How often have you had pleasant memories with your loved one TODAY?

    • Evaluation from mobile app

  6. 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

    Item: How often have you wished TODAY to get rid of your unpleasant emotions related to your loved one?

    • Evaluation from mobile app

  7. 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

    Item: How often have you tried TODAY to get rid of unpleasant thoughts related to your loved one?

    • Evaluation from mobile app

  8. 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

    Item: How often have you thought TODAY that you cannot believe that your beloved family has died?

    • Evaluation from mobile app

  9. 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

    Item: How often have you wished TODAY intensely that your loved one was with you?

Other outcomes

  1. Satisfaction with the treatment

    Time frame: At the end of 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

  2. Change in Prolonged Grief Disorder-13 (PG-13)

    Time frame: Before and after treatment, at 3 and 12 months

    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)

  3. Change in ADIS Clinician's severity rating scale

    Time frame: Before and after treatment, at 3 and 12 months

    Indicate the level of distress-interference in functioning. 1 item (from 0/"Absent" to 8/"Very severely disturbing/disabling") completed by the therapist.

Sponsors and collaborators

Lead sponsor

Universitat Jaume I

Other

Registry information

Official study title

An Internet-based Self Applied Treatment Program for Prolonged Grief Disorder (PGD): A Multiple-baseline Case Series Study

Acronym: PGD

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 6, 2020
Registry last updated
Feb 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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