Recurrent major depressive disorder Mental and Behavioural Disorders Recurrent major depressive disorder
Conditions
Interventions
Previously depressed participants will be randomly assigned to:
1. Preventive cognitive therapy (PCT) while continuing ADM (PCT + ADM)
2. PCT while tapering ADM (PCT – ADM)
3. Continuation ADM (ADM) c
Sponsors
NWO - Netherlands Organisation for Scientific Research, Dutch National Scientific Foundation, Dutch National Science Foundation
ZonMW - The Netherlands Organisation for Health Research and Development
Netherlands Organisation for Scientific Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Previously depressed participants: 1. A diagnosis of remitted MDD, with at least two previous depressive episodes in the past five years. 2. A current score of <10 on the Hamilton Rating Scale for Depression (HRSD) 3. Use of continuation ADM in the last six months before the start of the study 4. Age between 18 and 65 Healthy volunteers: 1. Age between 18 and 65 2. Match the previously depressed sample on age and gender
Exclusion criteria
Exclusion criteria: Previously depressed participants: 1. Current mania or hypomania or a history of bipolar illness 2. Any psychotic disorder (current and previous) 3. Organic brain damage 4. Alcohol or drug misuse 5. Predominant anxiety disorder 6. Current psychotherapy (> twice a month). Healthy volunteers: 1. Current or previous depressive episodes 2. Use of ADM.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Given that this is an exploratory study on processes of change, there are no primary outcome measures defined. To examine the research questions, the following measures will be used: 1. Affect, mood and mental imagery, collected using ESM. The experience sampling app “Imagine your mood” has been developed and programmed using TEMPEST software. The application has been programmed to set triggers for questionnaires 10 times a day, 3 days a week (on Thursdays, Fridays and Saturdays), for 8 weeks, resulting in a maximum of 240 completed responses. The triggers are set semi-randomly, between the hours of 7.30 and 22.30, with a maximum of one trigger per 90-minute interval and a minimum of 30 minutes between triggers. The ESM procedure will take place during the first 8 weeks of the study (parallel to the 8-week therapy period for previously depressed individuals who have been randomly assigned to receiving preventive cognitive therapy) 2. Relapse/recurrence over a follow-up period of minimal 15 months, using DSM-IV-TR criteria as assessed by the Structural Interview for DSM-IV (SCID, telephonic version) at 3 months, 9 months, at 15 months and at 24 months (current depressive symptomatology and previous 3, 6 or 9 months) 3. The ADM dose, assessed weekly during the ESM study period by telephone interviews | — |
Secondary
| Measure | Time frame |
|---|---|
| The following measures will be included for hypothesis-generating purposes: 1. Qualitative information on the use of the app, assessed in weekly phone calls during the 8-week ESM study period 2. Additional questions in the app questionnaire, assessed during the 8-week ESM study period (10 times a day, 3 days a week) using the experience sampling app “Imagine your mood”: 2.1. Questions on the impact of ESM 2.2. Further assessment of participants mental representation 2.3. Physical complaints 2.4. Current and previous activities and future events 3. Additional measures assessed in the trial ‘Disrupting the rhythm of depression’ as described in the study design and protocol (Netherlands Trial Register: NTR1907). | — |
Countries
Netherlands
Outcome results
None listed