Nurse-led self-help for recurrent depression in the primary care setting versus usual care; a pragmatic randomised trial and economic evaluation

Nurse-led self-help for recurrent depression in the primary care setting versus usual care; a pragmatic randomised trial and economic evaluation - PARADE-study: Prevention of Recurrent Depression in Primary Care

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39338

Enrollment

268

Registered

2012-01-10

Start date

2012-07-08

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent depression

Interventions

The investigational treatment in this trial is *nurse-led self-help* based on PCT

this preventive cognitive therapy has been demonstrated to be protective in recurrent depression for a period of at least 2 to 5,5 years.44 Patients will be offered a detailed treatment manual of th

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: age 18+ year current remission according to DSM-IV criteria (SCID) a least 2 confirmed previous MDD episodes with the SCID lifetime the last episode ended at least 8 weeks ago and no longer than 5 years ago the last episode lasted at least 2 weeks fluent in Dutch

Exclusion criteria

Exclusion criteria: current mania or hypomania or history of bipolar illness any current organic or psychotic disorder current or previous hospitalisation for alcohol or drug abuse severe sensory disabilities

Design outcomes

Primary

Measure	Time frame
- Effectiveness, defined as cumulative incidence of recurrences meeting DSM-IV criteria for a major depressive episode in the intervention group versus the control group - Cost-effectiveness, defined from a societal perspective meaning that the costs of the intervention, health care uptake, patients' out-of-pocket costs and costs due to productivity losses will be included in the economic evaluation and compared between groups	—

Measure

Time frame

- Effectiveness, defined as cumulative incidence of recurrences meeting DSM-IV criteria for a major depressive episode in the intervention group versus the control group - Cost-effectiveness, defined from a societal perspective meaning that the costs of the intervention, health care uptake, patients' out-of-pocket costs and costs due to productivity losses will be included in the economic evaluation and compared between groups

—

Secondary

Measure	Time frame
To study whether nurse-led self-help for patients with recurrent MDD versus usual care alone: A is (cost-)effective in reducing health care utilisation B is (cost-)effective in reducing co-morbid distress, anxiety and somatisation) C is satisfying according to patients D is (cost-)effective in certain subgroups of patients, particularly related to (i.e. modified by): - the number of previous episodes, - type of treatment for the last recurrence (AD, psychological intervention, noting etc). - the severity of residual depressive symptoms in the remitted phase - age of onset of the first depressive episode, - social economic status and - self-efficacy for managing,depression - symptoms of pain and/or fatigue	—

Measure

Time frame

To study whether nurse-led self-help for patients with recurrent MDD versus usual care alone: A is (cost-)effective in reducing health care utilisation B is (cost-)effective in reducing co-morbid distress, anxiety and somatisation) C is satisfying according to patients D is (cost-)effective in certain subgroups of patients, particularly related to (i.e. modified by): - the number of previous episodes, - type of treatment for the last recurrence (AD, psychological intervention, noting etc). - the severity of residual depressive symptoms in the remitted phase - age of onset of the first depressive episode, - social economic status and - self-efficacy for managing,depression - symptoms of pain and/or fatigue

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)