Evaluation of a French Unguided Internet-based Intervention for Adults Struggling With Their Partner's Loss

NCT03714516 | Completed

• 1 other identifier: 2018-00401
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to demonstrate the effectiveness of an unguided self-help program for people struggling with the loss of their partner, either by separation/divorce or death. The self-support program lasts 2 months and a half to 3 months. It was developed in German by a team from the University of Bern and has already proven its effectiveness. All participants will have direct access to the program (there will be no control group). The results obtained will be compared to those collected by the authors of the original program who administered the same intervention to a German-speaking population, however with support by e-mail. Participation is open to anyone aged 20 or over who has lost their partner through bereavement, divorce or separation at least 6 months ago, and who has difficulty overcoming this loss. However, it is not possible to participate if the person is on psychotherapeutic therapy, has started or changed psychotropic medication or if the person has any risk of suicide. Alternative possibilities of treatment will be proposed. The self-support consists of 10 modules, which contain information about the process of loss, self-reflection tasks, activities, questionnaires and self-observation grids. Participants are free to do the modules as many times as they wish. They will also be asked three times to complete questionnaires taking an average of 40 minutes. This will take place before the start of the program, at the end of the program, and 3 months after the end of the intervention. At the end of the program, participants will be asked for feedback on the program. These data and remarks will allow to rethink and improve the care of people with difficulties overcoming the loss of a loved one. Participants will be recruited by contacting various associations dealing with bereavement and / or separation, as well as by posting advertisements or articles in the media (social or conventional) in the French-speaking part of Switzerland.

Conditions

Complicated Grief

Outcome Measures

Primary Outcomes (1)

• Change in complicated grief symptoms (score at the Inventory of Complicated Grief)

  assessed with: Inventory of Complicated Grief (Prigerson et al., 1995; Zech, 2012), on a scale ranging from 0 = never to 4 = always. The mean score is used as a final score. Higher score represent a higher symptom load.

  Pretest / 12-week posttest / 3-month Follow-up

Secondary Outcomes (10)

• Change in Anxiety and Depression symptoms (score at the Hospital Anxiety and Depression Scale)

  Pretest / 12-week posttest / 3-month Follow-up

• Change in Psychological Well-Being (score at the Psychological Well-Being Scales)

  Pretest / 12-week posttest / 3-month Follow-up

• Change in Satisfaction with Life (score at the Satisfaction with Life Scale)

  Pretest / 12-week posttest / 3-month Follow-up

• Change in Grief-Related Avoidance (score at the Grief-Related Avoidance Questionnaire)

  Pretest / 12-week posttest / 3-month Follow-up

• Change in Coping strategies (score at the Brief-COPE)

  Pretest / 12-week posttest / 3-month Follow-up

Study Arms (1)

Online psychological intervention

EXPERIMENTAL

The intervention is a non-controlled unguided internet-based self-help intervention for adults who seek support for coping with prolonged grief symptoms after romantic bereavement or separation/ divorce. The self-help program consists of 10 text-based sessions based on cognitive-behavioral psychotherapy techniques.

Behavioral: Psychological internet intervention

Interventions

Psychological internet intervention BEHAVIORAL

The intervention is a non-controlled unguided internet-based self-help intervention for adults who seek support for coping with prolonged grief symptoms after romantic bereavement or separation/ divorce. The self-help program consists of 10 text-based sessions based on cognitive-behavioral psychotherapy techniques.

Online psychological intervention

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Romantic bereavement or separation/divorce. Either of these events must have happened more than 6 months before participating in the study.
• Subjective distress and need for support to cope with the loss
• Age: 20 years or older
• Internet access
• Mastery of the French language
• Approved Informed Consent (Appendix Informed Consent Form)

You may not qualify if:

• Moderate to acute current suicidality (BDI-II item 9 \> 1)
• Severe psychological or somatic disorders which need immediate treatment.
• Concomitant psychotherapy (participants may take part in the self-help intervention, but will not be included in the study.)
• Prescribed drugs against depression or anxiety, if prescription or dosage has changed in the month prior or during the self-help intervention.
• Inability to follow the procedures of the study, e.g. due to comprehension problems
• Enrolment of the investigator, his/her family members, employees and other dependent persons.

Sponsors & Collaborators

• University of Lausanne: lead

Study Sites (1)

University of Lausanne - Institute of Psychology

Lausanne, Canton of Vaud, 1015, Switzerland

Location

Related Publications (1)

• Efinger, L., Debrot, A., & Pomini, V. (2021). LIVIA-FR : Implémentation et évaluation d'une intervention par Internet pour des personnes francophones peinant à surmonter la perte de leur partenaire. Annales Médico-Psychologiques, Revue Psychiatrique. Advance online publication. https://doi.org/10.1016/j.amp.2021.05.004

  BACKGROUND

Related Links

• Recruitment page

Study Officials

• Valentino Pomini, Prof.

  University of Lausanne

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: non-controlled evaluation pilot study with pre-, post- and follow-up assessments

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: October 22, 2018
• Study Start: September 12, 2018
• Primary Completion: December 31, 2020
• Study Completion: June 4, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Access Criteria: We demand that the purpose of the request is clearly stated.

Locations

CH (1)