Ignite Creation Date:
2024-05-06 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05280041
Status:
RECRUITING
Last Update Posted:
2023-10-11
First Post:
2022-02-02
Brief Title:
Optimising an Online Self-help Program for Coping With the Loss of a Spouse
Sponsor:
Jeannette Brodbeck
Organization:
University of Applied Sciences and Arts Northwestern Switzerland
Study Overview
Official Title:
An Online Self-help Intervention for Coping With the Loss of a Partner Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOLENA
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 SOLENAs modules in a fixed order
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 SOLENAs modules in a fixed order
Detailed Description:
BACKGROUND AND RATIONALE
The death of a spouse is a frequent and very stressful critical life event in later life The loss of a partner involves the adaptation of daily routines which can be even more challenging when social physical and financial resources decline in later life Grief and psychological distress after the loss of a spouse are normative reactions For most people grief intensity weakens to a manageable degree within several weeks or months However some individuals are less able to cope with bereavement and show symptoms of disturbed or prolonged grief or adaptation problems
To support coping with the loss of a significant person the Task model identifies four tasks of mourning namely accepting the reality of the loss experiencing the pain of grief adjusting to an environment without the deceased person and withdrawing emotional energy and reinvesting it in another relationship Moreover the dual-process model of coping with bereavement posits that a dynamic coping process oscillating between loss-oriented tasks such as grief work and restoration-oriented tasks such as attending to life changes is essential for adjustment
Based in these two models Brodbeck and colleagues developed LIVIA a text-based self-help online program to support the loss of the spouse which has proved its efficacy for mourning older adults from a general population LIVIA is rooted in cognitive behavioural therapy including the most relevant treatment elements to support the mourning process exposure cognitive reappraisal integration and restoration as well as self-care and social reengagement treatment components
LIVIA confirmed that the intervention is also efficacious for milder grief symptoms Compared to the control group the intervention resulted in significant reductions in grief d 081 depression d 059 psychopathological distress d 039 primary outcomes embitterment d 037 loneliness d 037 and an increase in life satisfaction d -041 secondary outcomes These gains were maintained over three months Improvements were similar among participants with low medium or high levels of grief at baseline Therefore LIVIA provides a promising basis for the development of a more sophisticated and attractive intervention with a more inclusive target group eg mourners of all ages who lost their spouse within the previous six months while still seeking help for coping with the loss
Apart from extending the target population of the intervention SOLENA also aims to examine whether the efficacy of LIVIA can be increased by providing a self-tailored version in which the users can chose the content that is relevant for them and that best fits their current needs
MAIN HYPOTHESES
Primary outcome Grief
1 Efficacy of SOLENA It is hypothesized that SOLENA will decrease grief significantly compared to the waiting list control group
2 Stability of the effects It is hypothesized that SOLENA leads to stable effects on grief across 10 weeks
3 Comparison of the two active arms When assessing the presentation format of SOLENA it is hypothesized that self-tailored arm will lead to higher decrease of grief than the standardised arm
Secondary outcomes Depression symptoms and perceived loneliness
4 Efficacy of SOLENA It is hypothesized that SOLENA will decrease depression symptoms and perceived loneliness significantly compared to the waiting list control or treatment as usual group
5 Stability of the effects It is hypothesized that SOLENA leads to stable effects on depression symptoms and loneliness across 10 weeks
6 Comparison of the two active arms When assessing the presentation format of SOLENA it is hypothesized that self-tailored arm will lead to higher depression symptoms and loneliness than the standardised arm superiority hypothesis
RECRUITMENT AND PROCEDURE
Recruitment of participants will be conducted via newspaper articles social media internet forums and personal contacts to healthcare workers and churches Potential participants will find a description of the study and the intervention on the project website from where they can register at the study All potential participants can contact the study management to ask questions or clear eventual doubts about the study This presentation is compiled in accordance with the general guidelines for clinical trials published by the Swiss Ethics Committees on research involving humans for the creation of an informed consent form ICF for information transfer
After receiving adequate and sufficient information about the study the participants will declare consent by signing the ICF All participants must confirm to have read this information before being allowed to participate in the study
After sending back the signed informed consent participants will be invited to fill out the baseline measures on REDCap and take part in a short telephone call for screening the inclusion and exclusion criteria
Participants will be randomised to one of the three study arms fixed-standardized self-tailored or waiting list control group and will receive the participant code to connect their data with study condition ensuring confidentiality and privacy
For 10 weeks starting at t0 participants will be asked to use the text-based program SOLENA to support their grief process and to complete the working alliance goal task change mechanisms measures and the self-check mood monitoring
At week 10 t1 post-intervention participants of the active arms will be asked to complete the primary and secondary measures At this moment the waiting-list control group starts using SOLENA and complete baseline measures
At week 20 t2 follow-up participants of the active arms will be asked to complete primary and secondary outcome measures to assess stability of programs effects Also at this time participants in the waiting list control group will complete post-intervention measures
At week 30 t3 participants in the waiting list control group will complete follow-up measures
STATISTICAL ANALYSES PLAN
Statistical analyses
Analyses will be conducted according to the intention-to-treat paradigm Linear mixed-models which will be used in this study allow a different number of measurement points per participants and are thus less sensitive to missing data Time will be included pre vs post intervention measures and post intervention vs follow-up measures group self-tailored and standardised vs waiting list control condition and interaction terms as predictors of the outcome variables Cohens d will be calculated as effect size for all observed outcome variables To analyse the longitudinal interplay of predictor and mediator variables path analyses will be conducted Analyses will be conducted in SPSS R and Mplus Any deviation from the original statistical plan will be described and justified in the final trial report There are no statistical stopping rules in this trial
SAMPLE SIZE CALCULATIONS
The study is mainly powered for the efficacy and stability hypotheses ie the main and interaction effects of the active conditions compared to the waiting list control on the reduction of grief depression symptoms and loneliness The sample size needed was obtained conducting a power analysis with a probability level of 05 and a power of 080 with GPower based on the results of the evaluation of LIVIA ie large to moderate effects
For the comparison of SOLENA and a waiting list condition it is expected a large effect size of d 80 or f 4 For the comparison of the standardised and the self-tailored arms it is expected a small to moderate effect between f 25 and 15 in favour of the self-tailored arm Figure 4 presents the power analyses for a repeated measures ANOVA with a within-between interaction for three groups
A minimum of 85 participants will be included with an allocation ratio of 353515 for the two active conditions and the waiting list control group There is no statistical criterion for terminating the trial as more than 85 participants allow more sophisticated moderator analyses for example regarding the time since the loss
Data collection and analysis
Data are assessed using online questionnaires programmed in REDCap Data integrity is enforced through a variety of mechanisms ie referential data rules valid values range checks and consistency checks The option to choose a value from a list of valid codes and a description of what each code means is available where applicable Checks are applied at the time of data entry into a specific field In addition data on the use of the self-help sessions are collected within the platform All data will be saved in an anonymous way only identified by a code which is not related to the participants identity Servers are protected by high-end firewall systems Only the researchers directly involved in the study have access to the data
Handling of missing data and drop-outs
Dropout are defined as participants who withdraw actively from the intervention after randomisation or who do not fill out the post-intervention in spite of two reminders As for missing data by withdrawing actively from the intervention an e-mail will be sent with a REDCap link to the respective participants asking them to complete the post and follow-up questionnaires nonetheless thereby enabling us to conduct intention-to-treat analyses In any case all drop-outs are a part of the intent-to-treat sample as they have been randomised and are included in the analyses Analyses of the extent of missing data will be conducted to explore the missing data patterns and determine the type of missing data Missing Completely at Random Missing at Random Not Missing at Random Missing values will be substituted using multiple imputations Sensitivity analyses will explore the impact of the imputation of missing values
The death of a spouse is a frequent and very stressful critical life event in later life The loss of a partner involves the adaptation of daily routines which can be even more challenging when social physical and financial resources decline in later life Grief and psychological distress after the loss of a spouse are normative reactions For most people grief intensity weakens to a manageable degree within several weeks or months However some individuals are less able to cope with bereavement and show symptoms of disturbed or prolonged grief or adaptation problems
To support coping with the loss of a significant person the Task model identifies four tasks of mourning namely accepting the reality of the loss experiencing the pain of grief adjusting to an environment without the deceased person and withdrawing emotional energy and reinvesting it in another relationship Moreover the dual-process model of coping with bereavement posits that a dynamic coping process oscillating between loss-oriented tasks such as grief work and restoration-oriented tasks such as attending to life changes is essential for adjustment
Based in these two models Brodbeck and colleagues developed LIVIA a text-based self-help online program to support the loss of the spouse which has proved its efficacy for mourning older adults from a general population LIVIA is rooted in cognitive behavioural therapy including the most relevant treatment elements to support the mourning process exposure cognitive reappraisal integration and restoration as well as self-care and social reengagement treatment components
LIVIA confirmed that the intervention is also efficacious for milder grief symptoms Compared to the control group the intervention resulted in significant reductions in grief d 081 depression d 059 psychopathological distress d 039 primary outcomes embitterment d 037 loneliness d 037 and an increase in life satisfaction d -041 secondary outcomes These gains were maintained over three months Improvements were similar among participants with low medium or high levels of grief at baseline Therefore LIVIA provides a promising basis for the development of a more sophisticated and attractive intervention with a more inclusive target group eg mourners of all ages who lost their spouse within the previous six months while still seeking help for coping with the loss
Apart from extending the target population of the intervention SOLENA also aims to examine whether the efficacy of LIVIA can be increased by providing a self-tailored version in which the users can chose the content that is relevant for them and that best fits their current needs
MAIN HYPOTHESES
Primary outcome Grief
1 Efficacy of SOLENA It is hypothesized that SOLENA will decrease grief significantly compared to the waiting list control group
2 Stability of the effects It is hypothesized that SOLENA leads to stable effects on grief across 10 weeks
3 Comparison of the two active arms When assessing the presentation format of SOLENA it is hypothesized that self-tailored arm will lead to higher decrease of grief than the standardised arm
Secondary outcomes Depression symptoms and perceived loneliness
4 Efficacy of SOLENA It is hypothesized that SOLENA will decrease depression symptoms and perceived loneliness significantly compared to the waiting list control or treatment as usual group
5 Stability of the effects It is hypothesized that SOLENA leads to stable effects on depression symptoms and loneliness across 10 weeks
6 Comparison of the two active arms When assessing the presentation format of SOLENA it is hypothesized that self-tailored arm will lead to higher depression symptoms and loneliness than the standardised arm superiority hypothesis
RECRUITMENT AND PROCEDURE
Recruitment of participants will be conducted via newspaper articles social media internet forums and personal contacts to healthcare workers and churches Potential participants will find a description of the study and the intervention on the project website from where they can register at the study All potential participants can contact the study management to ask questions or clear eventual doubts about the study This presentation is compiled in accordance with the general guidelines for clinical trials published by the Swiss Ethics Committees on research involving humans for the creation of an informed consent form ICF for information transfer
After receiving adequate and sufficient information about the study the participants will declare consent by signing the ICF All participants must confirm to have read this information before being allowed to participate in the study
After sending back the signed informed consent participants will be invited to fill out the baseline measures on REDCap and take part in a short telephone call for screening the inclusion and exclusion criteria
Participants will be randomised to one of the three study arms fixed-standardized self-tailored or waiting list control group and will receive the participant code to connect their data with study condition ensuring confidentiality and privacy
For 10 weeks starting at t0 participants will be asked to use the text-based program SOLENA to support their grief process and to complete the working alliance goal task change mechanisms measures and the self-check mood monitoring
At week 10 t1 post-intervention participants of the active arms will be asked to complete the primary and secondary measures At this moment the waiting-list control group starts using SOLENA and complete baseline measures
At week 20 t2 follow-up participants of the active arms will be asked to complete primary and secondary outcome measures to assess stability of programs effects Also at this time participants in the waiting list control group will complete post-intervention measures
At week 30 t3 participants in the waiting list control group will complete follow-up measures
STATISTICAL ANALYSES PLAN
Statistical analyses
Analyses will be conducted according to the intention-to-treat paradigm Linear mixed-models which will be used in this study allow a different number of measurement points per participants and are thus less sensitive to missing data Time will be included pre vs post intervention measures and post intervention vs follow-up measures group self-tailored and standardised vs waiting list control condition and interaction terms as predictors of the outcome variables Cohens d will be calculated as effect size for all observed outcome variables To analyse the longitudinal interplay of predictor and mediator variables path analyses will be conducted Analyses will be conducted in SPSS R and Mplus Any deviation from the original statistical plan will be described and justified in the final trial report There are no statistical stopping rules in this trial
SAMPLE SIZE CALCULATIONS
The study is mainly powered for the efficacy and stability hypotheses ie the main and interaction effects of the active conditions compared to the waiting list control on the reduction of grief depression symptoms and loneliness The sample size needed was obtained conducting a power analysis with a probability level of 05 and a power of 080 with GPower based on the results of the evaluation of LIVIA ie large to moderate effects
For the comparison of SOLENA and a waiting list condition it is expected a large effect size of d 80 or f 4 For the comparison of the standardised and the self-tailored arms it is expected a small to moderate effect between f 25 and 15 in favour of the self-tailored arm Figure 4 presents the power analyses for a repeated measures ANOVA with a within-between interaction for three groups
A minimum of 85 participants will be included with an allocation ratio of 353515 for the two active conditions and the waiting list control group There is no statistical criterion for terminating the trial as more than 85 participants allow more sophisticated moderator analyses for example regarding the time since the loss
Data collection and analysis
Data are assessed using online questionnaires programmed in REDCap Data integrity is enforced through a variety of mechanisms ie referential data rules valid values range checks and consistency checks The option to choose a value from a list of valid codes and a description of what each code means is available where applicable Checks are applied at the time of data entry into a specific field In addition data on the use of the self-help sessions are collected within the platform All data will be saved in an anonymous way only identified by a code which is not related to the participants identity Servers are protected by high-end firewall systems Only the researchers directly involved in the study have access to the data
Handling of missing data and drop-outs
Dropout are defined as participants who withdraw actively from the intervention after randomisation or who do not fill out the post-intervention in spite of two reminders As for missing data by withdrawing actively from the intervention an e-mail will be sent with a REDCap link to the respective participants asking them to complete the post and follow-up questionnaires nonetheless thereby enabling us to conduct intention-to-treat analyses In any case all drop-outs are a part of the intent-to-treat sample as they have been randomised and are included in the analyses Analyses of the extent of missing data will be conducted to explore the missing data patterns and determine the type of missing data Missing Completely at Random Missing at Random Not Missing at Random Missing values will be substituted using multiple imputations Sensitivity analyses will explore the impact of the imputation of missing values
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None