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Clinical Trials/NCT02900534
NCT02900534
Completed
N/A

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

University of Bern1 site in 1 country110 target enrollmentMay 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prolonged Grief Symptoms
Sponsor
University of Bern
Enrollment
110
Locations
1
Primary Endpoint
Grief symptoms
Status
Completed
Last Updated
7 years ago

Overview

Brief 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.
Registry
clinicaltrials.gov
Start Date
May 2016
End Date
May 6, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Grief symptoms

Time Frame: 6 months after the start of the intervention

Texas Revised Inventory of Grief (German version, Znoj,2008; Faschingbauer, 1981)

Psychological distress

Time Frame: 6 months after the start of the intervention

Brief Symptom Inventory (German version, Franke, 2000)

Secondary Outcomes

  • Depression symptoms(6 months after the start of the intervention)
  • Satisfaction with life(6 months after the start of the intervention)
  • Embitterment(6 months after the start of the intervention)

Study Sites (1)

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