Internet-based Self-help After Spousal Bereavement or Divorce

Study Overview
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Brief Summary
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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: 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. The effects in the intervention group are larger than the effects in the waiting control group. These effects are stable from the post measure at 12 weeks to the 6-month follow-up.

Official Title
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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

Conditions
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Prolonged Grief Symptoms

Intervention / Treatment
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* Other: Internet-based self-help


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based self-help<br>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<br>* 10 internet-based self-help sessions plus one supportive email a week with a cognitive-behavioural background<br>|
| No Intervention: Waiting control group<br> | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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grief, depression, bereavement, divorce, online self-help