Onderzoek naar het gebruik van drie online trainingen voor slapen, stress en piekeren met begeleiding in de huisartsenpraktijk voor het verminderen van depressieve klachten

RATIONALE

Depression is major public health concern. Currently available interventions for preventing and reducing depression have proven to be effective, However, the reach of these interventions needs to be improved, and their implementation in primary care needs to be stimulated and supported, especially among people with a low socioeconomic status (SES).



OBJECTIVE

The main objective is to evaluate whether a SES-sensitive implementation strategy improves the participation rate (i.e. reach) of lower SES patients in the blended online CDMIs as compared to a regular implementation strategy. Secondary objectives are to evaluate the implementation process, to monitor and evaluate psychological complaints and well-being over time, and to evaluate the difference in costs associated with both implementation strategies.



STUDY DESIGN

The study is a pragmatic cluster randomised controlled trial, conducted in primary care.

Study population: GP nurses will be recruited through two collaborating parties in this project, working in the primary care field and employing GP nurses. All adult (18+) patients of the participating primary care practices who present to their (participating) GP nurse with sleep, worry or stress complaints, have access to internet, and have sufficient proficiency of the Dutch language.

Intervention (if applicable): The blended online CDMIs will be offered in both conditions. The difference between de experimental and control condition is the implementation strategy being used. In the experimental condition GP nurses will be trained to implement the online CDMIs with a SES-sensitive implementation strategy, while a regular implementation strategy applies to the control condition. The implementation strategies involve activities that are aimed at the GP-nurses and at the patients they see.



MAIN STUDY PARAMETERS:

The primary outcome is the difference in the participation rate of patients with a lower SES between the SES-sensitive and the regular implementation strategy. Participation is defined as participating in at least 1 face-to-face session with a GP nurse and engaging with at least 2 exercises in the online CDMIs. Secondary outcomes include process indicators of the implementation process (satisfaction, feasibility, fidelity and adherence) and the impact on depressive complaints (PHQ-8), sleep problems (JSEQ), stress (PSS-10), worry (PSWQ), anxiety (GAD-7) and well-being (WHO-5).



NATURE AND EXTENT OF THE BURDEN AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT AND GROUP RELATEDNESS

229 patients will be assessed three times by online self-reported questionnaires: at baseline (T0), 3 months after baseline (T1) and 12 months after baseline (T2). A substantial part of the baseline questionnaire and follow-up questionnaires of the study are already part of the intake and follow-up questionnaires of the online CDMIs. In addition, we will conduct in-depth interviews with 10 patients to illicit experiences with the intervention. This study is very unlikely to have any negative side effects or risks to participants. Both groups will have access to an evidence-based online interventions for stress, sleep and worry complaints with guidance from their GP nurse. Moreover, all participants have access to standard usual care delivered by their GP/GP nurse. Participants in the intervention condition may receive more active, directive, and SES-specific guidance than the control condition.

The reach of online interventions for depression is relatively low among people with a low socioeconomic status (SES) as compared to people with a high SES.

The hypothesis is that the participation rate of patients with a lower socioeconomic status to the blended online complaint-directed mini-interventions will increase using a lower-SES implementation strategy in comparision to a regular implementation strategy.

Quantitative (online questionnaires):

1. At baseline

2. 3 months after baseline

3. 12 months after baseline



Qualitative (interviews with 10 patients): 1 to 6 months after baseline.

In the interviews we will illicit patient's experiences with the intervention, their preferences for the delivery of the intervention in primary care, and factors that they deem relevant for the sustained (successful) implementation of the intervention

The online CDMIs will be offered with guidance from a GP (mental health) nurse in both conditions. The difference between the experimental and control condition is the implementation strategy being used. In the experimental condition, GP nurses will be trained to implement the online CDMIs with a SES-sensitive implementation strategy, while a regular implementation strategy applies to the control condition. The implementation strategies involve activities that are aimed at the GP nurses and at the patients they see.