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

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ClinicalTrials.gov Identifier: NCT02900534
Recruitment Status : Completed
First Posted : September 14, 2016
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
University of Bern

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prolonged Grief Symptoms Other: Internet-based self-help Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2016
Actual Primary Completion Date : May 6, 2018
Actual Study Completion Date : May 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bereavement

Arms and Interventions
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Arm Intervention/treatment
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
No Intervention: Waiting control group


Outcome Measures
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Primary Outcome Measures :
  1. Grief symptoms [ Time Frame: 12 weeks after the start of the intervention ]
    Texas Revised Inventory of Grief (German version, Znoj,2008; Faschingbauer, 1981)

  2. Psychological distress [ Time Frame: 12 weeks after the start of the intervention ]
    Brief Symptom Inventory (German version, Franke, 2000)

  3. Grief symptoms [ Time Frame: 6 months after the start of the intervention ]
    Texas Revised Inventory of Grief (German version, Znoj,2008; Faschingbauer, 1981)

  4. Psychological distress [ Time Frame: 6 months after the start of the intervention ]
    Brief Symptom Inventory (German version, Franke, 2000)


Secondary Outcome Measures :
  1. Depression symptoms [ Time Frame: 12 weeks after the start of the intervention ]
    Beck Depression Inventory II (German version, Hautzinger, Kühne & Keller, 2006)

  2. Depression symptoms [ Time Frame: 6 months after the start of the intervention ]
    Beck Depression Inventory II (German version, Hautzinger, Kühne & Keller, 2006)

  3. Satisfaction with life [ Time Frame: 12 weeks after the start of the intervention ]
    Satisfaction with life scale (German version, Schumacher, 2003)

  4. Satisfaction with life [ Time Frame: 6 months after the start of the intervention ]
    Satisfaction with life scale (German version, Schumacher, 2003)

  5. Embitterment [ Time Frame: 12 weeks after the start of the intervention ]
    Embitterment questionnaire (Znoj &, Schyder, 2014)

  6. Embitterment [ Time Frame: 6 months after the start of the intervention ]
    Embitterment questionnaire (Znoj &, Schyder, 2014)


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900534


Locations
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Switzerland
University of Bern
Bern, Switzerland, 3012
Sponsors and Collaborators
University of Bern
Investigators
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Study Director: Hans J Znoj, Professor University of Bern, Switzerland
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT02900534    
Other Study ID Numbers: Basec2016-00180
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Bern:
grief
depression
bereavement
divorce
online self-help