NCT02900534

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. 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. 2.The effects in the intervention group are larger than the effects in the waiting control group.
  3. 3.These effects are stable from the post measure at 12 weeks to the 6-month follow-up.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2018

Completed
Last Updated

October 22, 2018

Status Verified

October 1, 2018

Enrollment Period

2 years

First QC Date

September 1, 2016

Last Update Submit

October 19, 2018

Conditions

Prolonged Grief Symptoms

Keywords

griefdepressionbereavementdivorceonline self-help

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (6)

  • Depression symptoms

    12 weeks after the start of the intervention

  • Depression symptoms

    6 months after the start of the intervention

  • Satisfaction with life

    12 weeks after the start of the intervention

  • Satisfaction with life

    6 months after the start of the intervention

  • Embitterment

    12 weeks after the start of the intervention

  • +1 more secondary outcomes

Study Arms (2)

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).

Other: Internet-based self-help

Waiting control group

NO INTERVENTION

Interventions

Internet-based self-helpOTHER

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

Internet-based self-help

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)
  • Inability to follow the procedures of the study, e.g. due to comprehension problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bern

Bern, 3012, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 35522459DERIVED

  • 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.

    PMID: 31003114DERIVED

  • 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.

    PMID: 28086836DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Hans J Znoj, Professor

    University of Bern, Switzerland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 14, 2016

Study Start

May 1, 2016

Primary Completion

May 6, 2018

Study Completion

May 6, 2018

Last Updated

October 22, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)