Internet-based Self-help After Spousal Bereavement or Divorce (LIVIA)

October 19, 2018 updated by: University of Bern

Evaluation of a Randomised Guided Internet-based Self-help Intervention for Older Adults Who Seek Support for Coping With Prolonged Grief Symptoms After Marital Bereavement or Divorce - LIVIA

The purpose of this study is to evaluate the efficacy of an internet-based self-help intervention for older adults with prolonged grief symptoms after spousal bereavement or separation/divorce. The study design is a randomized trial with a waiting control condition of 12 weeks and a follow-up after 6 months. The investigators will test the following main hypotheses:

  1. The intervention group shows a significant decrease in grief symptoms, psychological distress, depression symptoms and embitterment, and a significant increase in life satisfaction, as well as session related outcomes from baseline to 12 weeks post intervention assessment.
  2. The effects in the intervention group are larger than the effects in the waiting control group.
  3. These effects are stable from the post measure at 12 weeks to the 6-month follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3012
        • University of Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Marital bereavement or separation/divorce. Both events should have happened more than 6 months before participating in the study.
  • Seeking support for coping with grief symptoms
  • Internet access
  • Mastery of the German language
  • Informed Consent

Exclusion Criteria:

  • Acute suicidality (BDI Suicide item > 1 or suicidal ideation in the telephone interview)
  • No emergency plan: In the telephone interview, an emergency plan will be developed which specifies a health care professional, who participants can turn to in an acute crisis. If no such person or health care service can be found, individuals will be excluded from the intervention.
  • 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 lead to an exclusion 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Waiting control group
Experimental: Internet-based self-help
The self-help programme consists of 10 text-based sessions and one supportive E-Mail a week. The programme employs cognitive-behavioural interventions. The theoretical background is the Dual Process Model by Stroebe and Schutt (1999).
Other: Internet-based self-help
10 internet-based self-help sessions plus one supportive email a week with a cognitive-behavioural background

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grief symptoms
Time Frame: 12 weeks after the start of the intervention
Texas Revised Inventory of Grief (German version, Znoj,2008; Faschingbauer, 1981)
12 weeks after the start of the intervention
Psychological distress
Time Frame: 12 weeks after the start of the intervention
Brief Symptom Inventory (German version, Franke, 2000)
12 weeks after the start of the intervention
Grief symptoms
Time Frame: 6 months after the start of the intervention
Texas Revised Inventory of Grief (German version, Znoj,2008; Faschingbauer, 1981)
6 months after the start of the intervention
Psychological distress
Time Frame: 6 months after the start of the intervention
Brief Symptom Inventory (German version, Franke, 2000)
6 months after the start of the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression symptoms
Time Frame: 12 weeks after the start of the intervention
Beck Depression Inventory II (German version, Hautzinger, Kühne & Keller, 2006)
12 weeks after the start of the intervention
Depression symptoms
Time Frame: 6 months after the start of the intervention
Beck Depression Inventory II (German version, Hautzinger, Kühne & Keller, 2006)
6 months after the start of the intervention
Satisfaction with life
Time Frame: 12 weeks after the start of the intervention
Satisfaction with life scale (German version, Schumacher, 2003)
12 weeks after the start of the intervention
Satisfaction with life
Time Frame: 6 months after the start of the intervention
Satisfaction with life scale (German version, Schumacher, 2003)
6 months after the start of the intervention
Embitterment
Time Frame: 12 weeks after the start of the intervention
Embitterment questionnaire (Znoj &, Schyder, 2014)
12 weeks after the start of the intervention
Embitterment
Time Frame: 6 months after the start of the intervention
Embitterment questionnaire (Znoj &, Schyder, 2014)
6 months after the start of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bern

Investigators

  • Study Director: Hans J Znoj, Professor, University of Bern, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

May 6, 2018

Study Completion (Actual)

May 6, 2018

Study Registration Dates

First Submitted

September 1, 2016

First Submitted That Met QC Criteria

September 8, 2016

First Posted (Estimate)

September 14, 2016

Study Record Updates

Last Update Posted (Actual)

October 22, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Basec2016-00180

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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