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

NCT04462146 | Unknown

• 1 other identifier: z7dqxrg8
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prolonged Grief Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

  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

  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

  immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment

Other Outcomes (7)

• Change in Prolonged Grief Disorder-13 (PG-13) validated in Spanish population

  immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment

• Change in ADIS Clinician's severity rating scale

  immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment

• Change in The Structured Clinical Interview for Complicated Grief (SCI-CG)

  immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment

Study Arms (2)

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.

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.

Behavioral: Videoconference treatment with a therapist

Interventions

Internet-based Self Applied Treatment Program BEHAVIORAL

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

Also known as: GROw

Internet-based intervention

Videoconference treatment with a therapist BEHAVIORAL

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.

Face-to-face treatment by videoconference

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat Jaume I: lead

Study Sites (1)

Universitat Jaume I

Castellon, Spain

RECRUITING

Related Publications (30)

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  BACKGROUND

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  BACKGROUND

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• Tur C, Campos D, Herrero R, Mor S, Lopez-Montoyo A, Castilla D, Quero S. Internet-delivered Cognitive-Behavioral Therapy (iCBT) for Adults with Prolonged Grief Disorder (PGD): A Study Protocol for a Randomized Feasibility Trial. BMJ Open. 2021 Jul 6;11(7):e046477. doi: 10.1136/bmjopen-2020-046477.

  PMID: 34230018 DERIVED

Related Links

• International Classification of Diseases 11th Revision

MeSH Terms

Conditions

Prolonged Grief Disorder

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Soledad Quero, psychology

  Universitat Jaume I

  STUDY DIRECTOR

• Daniel Campos, psychology

  Universitat Jaume I

  STUDY DIRECTOR

• Cintia Tur, psychology

  Universitat Jaume I

  STUDY CHAIR

Central Study Contacts

Soledad Quero, psychology

CONTACT

+34 96 438 76 41; squero@uji.es

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: June 17, 2020
• First Posted: July 8, 2020
• Study Start: February 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: June 30, 2022
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

ES (1)