Prevention of recurrent depression with psychotherapy, led by a primary care nurse.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28129

Enrollment

268

Registered

2011-07-21

Start date

2012-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

recurrent depression, primary care, preventive cognitive therapy, nurse recidiverende depressie, terugkerende depressie, huisartsenpraktijk, preventieve cognitieve therapie, praktijkondersteuner

Interventions

The investigational treatment in this trial is ‘nurse-led self-help’ based on preventive cognitive therapy. Patients will be offered a detailed treatment manual of the therapy with literature, backgro

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-65 year; 2. At least 2 confirmed previous MDD episodes with the SCID 42 in the last 5 years; 3. The last episode was at least 8 weeks ago, the last episode lasted at least 2 weeks; 4. Current remission according to DSM-IV criteria (a current score of <10 in the 17 item HRSD); 5. Fluent in Dutch.

Exclusion criteria

Exclusion criteria: 1. Current mania or hypomania or history of bipolar illness; 2. Any current organic or psychotic disorder; 3. Current or previous hospitalisation for alcohol or drug abuse; 4. Severe sensory disabilities.

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is the cumulative incidence of recurrences meeting DSM-IV criteria for a major depressive episode in both arms. Along to this pragmatic trial the cost-effectiveness is measured, 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.	—

Measure

Time frame

The primary outcome measure is the cumulative incidence of recurrences meeting DSM-IV criteria for a major depressive episode in both arms. Along to this pragmatic trial the cost-effectiveness is measured, 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.

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Secondary

Measure	Time frame
To study whether nurse-led self-help for patients with recurrent MDD versus usual care alone: 1. Is (cost-)effective in reducing health care utilisation; 2. Is (cost-)effective in reducing co-morbid distress, anxiety and somatisation; 3. Is satisfying according to patients; 4. Is (cost-)effective in certain subgroups of patients, particularly related to (i.e. modified by): A. The number of previous episodes; B. Type of treatment for the last recurrence (AD, psychological intervention, noting etc); C. The severity of residual depressive symptoms in the remitted phase; D. Age of onset of the first depressive episode; E. Social economic status; F. Self-efficacy for managing depression; G. 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: 1. Is (cost-)effective in reducing health care utilisation; 2. Is (cost-)effective in reducing co-morbid distress, anxiety and somatisation; 3. Is satisfying according to patients; 4. Is (cost-)effective in certain subgroups of patients, particularly related to (i.e. modified by): A. The number of previous episodes; B. Type of treatment for the last recurrence (AD, psychological intervention, noting etc); C. The severity of residual depressive symptoms in the remitted phase; D. Age of onset of the first depressive episode; E. Social economic status; F. Self-efficacy for managing depression; G. Symptoms of pain and/or fatigue.

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Contacts

Public ContactKarolien Leliefeld

van der Boechorststraat 7 room: D5.27

k.leliefeld@vumc.nl+31 (0)20 4448395

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)