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Completed

NCT Number: NCT02900534

Internet-based Self-help After Spousal Bereavement or Divorce

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bern

Bern, 3012, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-based self-help

Other

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study 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

Acronym: LIVIA

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 14, 2016
Registry last updated
Oct 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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