Prolonged Grief SymptomsLIVIANCT02900534
Internet-based Self-help After Spousal Bereavement or Divorce
A study testing Internet-based self-help in people with Prolonged Grief Symptoms, run by University of Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Prolonged Grief Symptoms
- What is being tested?
- Internet-based self-help
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2016to 6 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Prolonged Grief Symptoms
- Being tested
- Internet-based self-help
- Keywords
- grief, depression, bereavement, divorce, online self-help
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based self-helpOther
10 internet-based self-help sessions plus one supportive email a week with a cognitive-behavioural background
| Study group | Role | What they receive |
|---|---|---|
| Internet-based self-help | Experimental | 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). Receives: Other: Internet-based self-help |
| Waiting control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grief symptoms
Texas Revised Inventory of Grief (German version, Znoj,2008; Faschingbauer, 1981)
Measured: 12 weeks after the start of the intervention
Psychological distress
Brief Symptom Inventory (German version, Franke, 2000)
Measured: 12 weeks after the start of the intervention
Grief symptoms
Texas Revised Inventory of Grief (German version, Znoj,2008; Faschingbauer, 1981)
Measured: 6 months after the start of the intervention
Psychological distress
Brief Symptom Inventory (German version, Franke, 2000)
Measured: 6 months after the start of the intervention
Secondary outcomes (6)
Depression symptoms
Beck Depression Inventory II (German version, Hautzinger, Kühne \& Keller, 2006)
Measured: 12 weeks after the start of the intervention
Depression symptoms
Beck Depression Inventory II (German version, Hautzinger, Kühne \& Keller, 2006)
Measured: 6 months after the start of the intervention
Satisfaction with life
Satisfaction with life scale (German version, Schumacher, 2003)
Measured: 12 weeks after the start of the intervention
Satisfaction with life
Satisfaction with life scale (German version, Schumacher, 2003)
Measured: 6 months after the start of the intervention
Embitterment
Embitterment questionnaire (Znoj \&, Schyder, 2014)
Measured: 12 weeks after the start of the intervention
Embitterment
Embitterment questionnaire (Znoj \&, Schyder, 2014)
Measured: 6 months after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startMay 2016
- Primary completion6 May 2018
- Study completion6 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prolonged Grief SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans J Znoj, Professor, Study director, University of Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900534
- Sponsor's protocol ID
- Basec2016-00180
- Acronym
- LIVIA
- Status last verified
- Oct 2018
- First submitted
- 1 Sep 2016
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Brodbeck J, Berger T, Biesold N, Rockstroh F, Schmidt SJ, Znoj H. The Role of Emotion Regulation and Loss-Related Coping Self-efficacy in an Internet Intervention for Grief: Mediation Analysis. JMIR Ment Health. 2022 May 6;9(5):e27707. doi: 10.2196/27707.
PubMed 35522459Brodbeck J, Berger T, Biesold N, Rockstroh F, Znoj HJ. Evaluation of a guided internet-based self-help intervention for older adults after spousal bereavement or separation/divorce: A randomised controlled trial. J Affect Disord. 2019 Jun 1;252:440-449. doi: 10.1016/j.jad.2019.04.008. Epub 2019 Apr 8.
PubMed 31003114Brodbeck J, Berger T, Znoj HJ. An internet-based self-help intervention for older adults after marital bereavement, separation or divorce: study protocol for a randomized controlled trial. Trials. 2017 Jan 13;18(1):21. doi: 10.1186/s13063-016-1759-5.
PubMed 28086836
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02900534
- Acronym / sponsor ID
- LIVIA / Basec2016-00180
- Conditions
- Prolonged Grief Symptoms
- Keywords
- grief, depression, bereavement, divorce, online self-help
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 6 May 2018 (actual)
- Study completion
- 6 May 2018 (actual)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based self-help | Experimental | Other: Internet-based self-helpThe 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). |
| Waiting control group | No intervention | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based self-help10 internet-based self-help sessions plus one supportive email a week with a cognitive-behavioural background | Other | Internet-based self-help |
Primary outcome
Grief symptoms
Time frame: 12 weeks after the start of the intervention
Texas Revised Inventory of Grief (German version, Znoj,2008; Faschingbauer, 1981)
Psychological distress
Time frame: 12 weeks after the start of the intervention
Brief Symptom Inventory (German version, Franke, 2000)
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)
6 secondary outcomes
Depression symptoms
Time frame: 12 weeks after the start of the intervention
Depression symptoms
Time frame: 6 months after the start of the intervention
Satisfaction with life
Time frame: 12 weeks after the start of the intervention
Satisfaction with life
Time frame: 6 months after the start of the intervention
Embitterment
Time frame: 12 weeks after the start of the intervention
Embitterment
Time frame: 6 months after the start of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Derived from this study: PubMed 35522459Brodbeck J, Berger T, Biesold N, Rockstroh F, Schmidt SJ, Znoj H. The Role of Emotion Regulation and Loss-Related Coping Self-efficacy in an Internet Intervention for Grief: Mediation Analysis. JMIR Ment Health. 2022 May 6;9(5):e27707. doi: 10.2196/27707.
- Derived from this study: PubMed 31003114Brodbeck J, Berger T, Biesold N, Rockstroh F, Znoj HJ. Evaluation of a guided internet-based self-help intervention for older adults after spousal bereavement or separation/divorce: A randomised controlled trial. J Affect Disord. 2019 Jun 1;252:440-449. doi: 10.1016/j.jad.2019.04.008. Epub 2019 Apr 8.
- Derived from this study: PubMed 28086836Brodbeck J, Berger T, Znoj HJ. An internet-based self-help intervention for older adults after marital bereavement, separation or divorce: study protocol for a randomized controlled trial. Trials. 2017 Jan 13;18(1):21. doi: 10.1186/s13063-016-1759-5.
- Individual participant dataSharing planned: No
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Evaluation of Grief Therapy Approaches for Bereaved Parents
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Not yet recruiting
AI-GF-GNW on Prolonged Grief Reactions
Artificial Intelligence (AI), Prolonged Grief Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans J Znoj, Professor study director
University of Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based self-help in people with Prolonged Grief Symptoms, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grief symptoms (time frame: 12 weeks after the start of the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02900534, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.