Imagine your mood: a step towards personalized relapse prevention in depression

• Register: ISRCTN
• Last refreshed on: 8 January 2024
• Main ID: ISRCTN15472145
• Date of registration: 17/11/2016
• Prospective Registration: No
• Primary sponsor: NWO - Netherlands Organisation for Scientific Research, Dutch National Scientific Foundation, Dutch National Science Foundation
• Public title: Imagine your mood: a step towards personalized relapse prevention in depression
• Scientific title: Using app-based Experience Sampling Methodology to explore processes of change in a randomized controlled (micro) trial on relapse prevention interventions for recurrent depression
• Date of first enrolment: 01/01/2014
• Target sample size: 60
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN15472145
• Study type: Interventional
• Study design: Single-blind randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Netherlands

Contacts

• Name: Claudi Bockting

Key inclusion & exclusion 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: 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.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Recurrent major depressive disorder
Mental and Behavioural Disorders
Recurrent major depressive disorder

Intervention(s)

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) control group

Participants in the PCT + ADM and PCT – ADM groups will receive eight weekly sessions of individual PCT. In the PCT – ADM group, participants will be instructed to gradually taper ADM in four weeks guided by their GP or psychiatrist, who will also be informed and advised. In the continuation ADM group and in the ADM + PCT group, participants and their GPs or psychiatrists will be advised to continue ADM.

Primary Outcome(s)

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 Outcome(s)

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).

Secondary ID(s)

NL 24000.097.08

Source(s) of Monetary Support

Nederlandse Organisatie voor Wetenschappelijk Onderzoek, ZonMw

Secondary Sponsor(s)

ZonMW - The Netherlands Organisation for Health Research and Development

Netherlands Organisation for Scientific Research

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; This micro-trial was conducted in a subset of patients that were included in the RCT “Disrupting the rhythm of depression” (Netherlands Trial Register: NTR1907). The addition of ESM to this RCT “Disrupting the rhythm of depression” was approved by the medical ethical board of University Medical Center Groningen, Groningen, 22/11/2013, ref: METc 2009/158. In addition, a group of matched healthy volunteers was included. Ethical approval for including these never-depress

Results

• Results available: Yes
• Date Completed: 01/06/2017