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

NCT04376385 | Completed

• 1 other identifier: z7dqxrg7
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Grief

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in frequency of sad memories

  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

  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

  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

  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

  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 Outcomes (3)

• Satisfaction with the treatment

  At the end of the treatment

• Change in Prolonged Grief Disorder-13 (PG-13)

  Before and after treatment, at 3 and 12 months

• Change in ADIS Clinician's severity rating scale

  Before and after treatment, at 3 and 12 months

Study Arms (5)

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

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

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

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

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

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

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat Jaume I: lead

Study Sites (1)

Universitat Jaume I

Castellon, Castellón, 12071, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: May 6, 2020
• Study Start: November 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: October 1, 2021
• Last Updated: February 28, 2022

Record last verified: 2022-02

Locations

ES (1)