Internet-based Self-help After Spousal Bereavement or Divorce

Prolonged Grief Symptoms Clinical Trial

— LIVIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02900534
• Other study ID #: Basec2016-00180
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: May 6, 2018

Study information

• Verified date: October 2018
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 6, 2018
• Est. primary completion date: May 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prolonged Grief Symptoms

Intervention

Other:
• Internet-based self-help
10 internet-based self-help sessions plus one supportive email a week with a cognitive-behavioural background

Locations

Country	Name	City	State
Switzerland	University of Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grief symptoms	Texas Revised Inventory of Grief (German version, Znoj,2008; Faschingbauer, 1981)	12 weeks after the start of the intervention
Primary	Psychological distress	Brief Symptom Inventory (German version, Franke, 2000)	12 weeks after the start of the intervention
Primary	Grief symptoms	Texas Revised Inventory of Grief (German version, Znoj,2008; Faschingbauer, 1981)	6 months after the start of the intervention
Primary	Psychological distress	Brief Symptom Inventory (German version, Franke, 2000)	6 months after the start of the intervention
Secondary	Depression symptoms	Beck Depression Inventory II (German version, Hautzinger, Kühne & Keller, 2006)	12 weeks after the start of the intervention
Secondary	Depression symptoms	Beck Depression Inventory II (German version, Hautzinger, Kühne & Keller, 2006)	6 months after the start of the intervention
Secondary	Satisfaction with life	Satisfaction with life scale (German version, Schumacher, 2003)	12 weeks after the start of the intervention
Secondary	Satisfaction with life	Satisfaction with life scale (German version, Schumacher, 2003)	6 months after the start of the intervention
Secondary	Embitterment	Embitterment questionnaire (Znoj &, Schyder, 2014)	12 weeks after the start of the intervention
Secondary	Embitterment	Embitterment questionnaire (Znoj &, Schyder, 2014)	6 months after the start of the intervention