Clinical trial NCT02900534: Internet-based Self-help After Spousal Bereavement or Divorce
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolonged Grief Symptoms
Keywords: grief
depression
bereavement
divorce
online self-help
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 110
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Grief symptoms
timeFrame: 12 weeks after the start of the intervention
measure: Psychological distress
timeFrame: 12 weeks after the start of the intervention
measure: Grief symptoms
timeFrame: 6 months after the start of the intervention
measure: Psychological distress
timeFrame: 6 months after the start of the intervention
Secondary outcomes:
measure: Depression symptoms
timeFrame: 12 weeks after the start of the intervention
measure: Depression symptoms
timeFrame: 6 months after the start of the intervention
measure: Satisfaction with life
timeFrame: 12 weeks after the start of the intervention
measure: Satisfaction with life
timeFrame: 6 months after the start of the intervention
measure: Embitterment
timeFrame: 12 weeks after the start of the intervention
measure: Embitterment
timeFrame: 6 months after the start of the intervention
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University of Bern
Study officials:
affiliation: University of Bern, Switzerland
name: Hans J Znoj, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Brodbeck 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.
citation: Brodbeck 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.