Optimising an Online Self-help Program for Coping With the Loss of a Spouse

NCT05280041 | Completed

• 1 other identifier: 2021-02221
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

When someone has lost his or her partner, feelings of grief are normal and usually diminish over time. However, for some people, strong feelings of grief persist. For coping with grief, it is important to learn to accept the loss, experience the pain of grief, adjust to an environment without the deceased person, and withdraw emotional energy and focus it on other relationships. Loss-oriented tasks, such as grief work, and restoration-oriented tasks, such as attending to life changes, engaging in new activities and finding new roles and identities, are both essential. The program is designed to be completed in 10 weeks and recommends that mourners complete one module or topic a week. To examine the benefits of SOLENA, this study will compare the answers of mourners that completed the intervention with the mourners of the control group, which will wait to complete the intervention. The group that completed the intervention is divided in two sub-groups. One group of mourners will complete the intervention in a fixed order, while the other will complete it in a self-tailored order according to their own needs at each moment. Specifically, the study examines how well the self-help program reduces grief, depression symptoms, and loneliness and examines whether the topics of the study modules are presented in a given order or whether participants can work on the topics according to their current needs makes a difference. Ultimately, it is expected that the self-tailored version leads to more benefits than completing SOLENA's modules in a fixed order.

Conditions

Grief

Keywords

Grief symptoms; Depression symptoms; Loneliness; Prolonged grief; Self-help online program

Outcome Measures

Primary Outcomes (1)

• Grief: Texas Revised Inventory of Grief - German Version

  Grief is assessed with the Texas Revised Inventory of Grief - German Version. The TRIG is a widely used measure to assess the severity of grief. The TRIG German version is a 16-item measure to assess the severity of grief from 1 = completely true to 5 = completely false. The scale ranges from 1 to 80, higher values indicate higher levels of grief.

  At week 10 (post-intervention)

Secondary Outcomes (2)

• Depression symptoms measured by The Patient Health Questionnaire (PHQ-9) German version.

  At week 10 (post-intervention)

• Perceived loneliness measured by the Jong Gierveld Loneliness Scale

  At week 10 (post-intervention)

Other Outcomes (6)

• User satisfaction with the program, measured by Patient Satisfaction Questionnaire (ZUF-8)

  At week 10 (post-intervention)

• Stability of improvement in grief: Texas Revised Inventory of Grief - German Version

  At week 20 (follow-up of the intervention)

• Stability of improvement in depression symptoms measured by The Patient Health Questionnaire (PHQ-9) German version.

  At week 20 (follow-up of the intervention)

Study Arms (3)

Fixed standardized - SOLENA-F

EXPERIMENTAL

In the fixed standardized arm participants will be asked to complete the study modules of the intervention (CBT intervention itself) in a fixed standardized order from module 1 to module 10. Participants will only be able to start the following module once they complete the previous one. At the beginning and at the end of each module it is emphasized what participants will do in the following module.

Behavioral: SOLENA - Online self-help program for older adults who lost the partner

Self-tailored - SOLENA-ST

EXPERIMENTAL

In the self-tailored arm participants will be asked to complete most of the study modules of the intervention (CBT intervention itself) in a flexible format, according to their own needs at each moment. Participants will be asked to start the intervention by completing the preparatory modules (modules 1 and 2) following a fixed order. After completion of module 2, all the remaining modules become available at the same time. At the beginning and at the end of each module, participants are invited to reflect on their own needs and to complete the modules that better meet them.

Behavioral: SOLENA - Online self-help program for older adults who lost the partner

Waiting list control group

NO INTERVENTION

Participants in this group will start the intervention 10 weeks after the randomization. Participants in the waiting list control group will be randomly distributed by the fixed standardised and self-tailored arms. This arm will follow the exact same procedure of the active arms.

Interventions

SOLENA - Online self-help program for older adults who lost the partner BEHAVIORAL

SOLENA follows the most relevant CBT elements of interventions for prolonged grief: 1) Exposure, e.g., telling the story of the loss; 2) cognitive reappraisal or restructuring of individual dysfunctional thoughts associated with the loss; 3) integration and restoration including self-care and social reengagement; and 4) behavioural activation. SOLENA's content is provided through a conversational virtual agent, Sol, who guides the user through the Study section the CBT intervention itself. In 10 study modules that address either the acceptance of the loss or the restoration and adaptation to a new life, SOLENA includes 1) readings, i.e., texts based about grief related topics that provide the background and rational for the module; and 2) exercises to encourage mourners to actively reflect on their grief and apply their new knowledge to their daily life and to practise the new routines regularly. SOLENA also provides users with the Notebook, Activities, and My Support sections.

Also known as: SOLENA

Fixed standardized - SOLENA-F; Self-tailored - SOLENA-ST

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Experience of spousal bereavement
• Seeking help for coping with grief or the psychosocial adaptation to a life without the partner
• Having access to an internet connection and adequate equipment
• Mastery of the German language
• An informed consent by the participant.

You may not qualify if:

• Loss less than one month ago
• Acute suicidality
• Inability to follow the procedures of the study, e.g., due to comprehension problems, visual impairment, lack of sufficient motor skills or severe psychological or somatic disorders which require immediate treatment which impedes the continuous work on the self-help programme.

Sponsors & Collaborators

• Jeannette Brodbeck: lead
• University of Bern: collaborator

Study Sites (1)

University of Applied Science Northwestern Switzerland

Olten, 4600, Switzerland

Location

Related Publications (12)

• 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: 28086836 BACKGROUND

• 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: 31003114 BACKGROUND

• Aoun SM, Breen LJ, Howting DA, Rumbold B, McNamara B, Hegney D. Who needs bereavement support? A population based survey of bereavement risk and support need. PLoS One. 2015 Mar 26;10(3):e0121101. doi: 10.1371/journal.pone.0121101. eCollection 2015.

  PMID: 25811912 BACKGROUND

• Boelen PA, de Keijser J, van den Hout MA, van den Bout J. Treatment of complicated grief: a comparison between cognitive-behavioral therapy and supportive counseling. J Consult Clin Psychol. 2007 Apr;75(2):277-84. doi: 10.1037/0022-006X.75.2.277.

  PMID: 17469885 BACKGROUND

• Eisma MC, Boelen PA, van den Bout J, Stroebe W, Schut HA, Lancee J, Stroebe MS. Internet-Based Exposure and Behavioral Activation for Complicated Grief and Rumination: A Randomized Controlled Trial. Behav Ther. 2015 Nov;46(6):729-48. doi: 10.1016/j.beth.2015.05.007. Epub 2015 May 28.

  PMID: 26520217 BACKGROUND

• Futterman A, Holland JM, Brown PJ, Thompson LW, Gallagher-Thompson D. Factorial validity of the Texas Revised Inventory of Grief-Present scale among bereaved older adults. Psychol Assess. 2010 Sep;22(3):675-87. doi: 10.1037/a0019914.

  PMID: 20822280 BACKGROUND

• Gomez Penedo JM, Berger T, Grosse Holtforth M, Krieger T, Schroder J, Hohagen F, Meyer B, Moritz S, Klein JP. The Working Alliance Inventory for guided Internet interventions (WAI-I). J Clin Psychol. 2020 Jun;76(6):973-986. doi: 10.1002/jclp.22823. Epub 2019 Jun 25.

  PMID: 31240727 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Martin A, Rief W, Klaiberg A, Braehler E. Validity of the Brief Patient Health Questionnaire Mood Scale (PHQ-9) in the general population. Gen Hosp Psychiatry. 2006 Jan-Feb;28(1):71-7. doi: 10.1016/j.genhosppsych.2005.07.003.

  PMID: 16377369 BACKGROUND

• Shear K, Frank E, Houck PR, Reynolds CF 3rd. Treatment of complicated grief: a randomized controlled trial. JAMA. 2005 Jun 1;293(21):2601-8. doi: 10.1001/jama.293.21.2601.

  PMID: 15928281 BACKGROUND

• Stroebe M, Schut H. The dual process model of coping with bereavement: rationale and description. Death Stud. 1999 Apr-May;23(3):197-224. doi: 10.1080/074811899201046.

  PMID: 10848151 BACKGROUND

• Brodbeck J, Jacinto S, Gouveia A, Mendonca N, Madorin S, Brandl L, Schokking L, Rodrigues AM, Goncalves J, Mooser B, Marques MM, Isaac J, Nogueira V, Matos Pires A, van Velsen L. A Web-Based Self-help Intervention for Coping With the Loss of a Partner: Protocol for Randomized Controlled Trials in 3 Countries. JMIR Res Protoc. 2022 Nov 30;11(11):e37827. doi: 10.2196/37827.

  PMID: 36449341 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jeannette Brodbeck, PhD

  University of Applied Sciences and Arts Northwestern Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: The study is a single-centered randomized control trial with three arms: Two active arms correspond to the two intervention conditions in which the content is presented in a fixed standardised order (SOLENA-F) and a self-tailored order in which the participants select the modules and their sequence (SOLENA-ST) as well as the waiting list control group.

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: March 15, 2022
• Study Start: April 4, 2022
• Primary Completion: December 17, 2025
• Study Completion: December 18, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)