The Icelandic depression vulnerability and mindfulness study: A randomized controlled trial

• Register: ISRCTN
• Last refreshed on: 13 July 2020
• Main ID: ISRCTN92714827
• Date of registration: 19/02/2018
• Prospective Registration: Yes
• Primary sponsor: The National Bioethics Committee
• Public title: The Icelandic depression vulnerability and mindfulness study: A randomized controlled trial
• Scientific title: Vulnerability to recurrent depression: Reactivity, content and habitual characteristics of dynamic cognitive processes and the effect of MBCT on their functioning
• Date of first enrolment: 20/02/2018
• Target sample size: 100
• Recruitment status: Ongoing
• URL: http://isrctn.com/ISRCTN92714827
• Study type: Interventional
• Study design: Randomized controlled trial (Prevention)
• Phase: Not Applicable

Countries of recruitment

Iceland

Contacts

• Name: Ragnar Ólafsson

Key inclusion & exclusion criteria

Inclusion criteria:
1. Participants have to be between 18 and 65 years of age at study entry
2. History of 3 or more major depressive episode (according to the DSM-IV diagnostic criteria evaluated in the MINI diagnostic interview) with, at least, two episodes within the last five years of which one must have occurred within the last two years
3. There are at least 2 months since the last depressive episode ended
4. Giving informed consent

Exclusion criteria:
1. Current major depressive episode
2. Moderate or severe depression symptoms (a score >19 on the Beck Depression Inventory - II)
3. Unstable anti-depressive medication treatment during past 8 weeks and/or changes to current treatment planned or anticipated during the next four months
4. Psychotherapy targeting depression, current or during the past month and/or participation in psychotherapy targeting depression scheduled during the next four months
5. Practices mediation and/or yoga on a regular basis
6. Current or past manic or hypomanic episodes
7. Current or past psychotic disorder
8. Presence of substance abuse within last 12 months
9. Presence of active and serious suicidal thoughts
10. Inability to complete baseline assessment (e.g. due to language or cognitive difficulties)


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Recurrent major depression
Mental and Behavioural Disorders
Recurrent major depression

Intervention(s)

Participants are randomised to an 8 week Mindfulness-Based Cognitive Therapy group prevention strategy for depressive episodes (MBCT) or a no-treatment waiting-list for the same duration.

Block randomisation (block size 4) is used to randomly allocate participants (in a 1:1 ratio) to either study group using computer-generated random numbers. Randomisation is stratified according to current use of antidepressant medication (yes; no) and symptom status at intake using the Beck Depression Inventory – II (asymptomatic = 0-13; partially symptomatic = 14-19). The MBCT treatment consists of eight weekly 2-hour-long group sessions with 10 to 14 participants in each group. The treatment is delivered following the treatment protocol of Segal et al. (2002). Session content includes guided mindfulness practices (i.e. body scan, sitting meditation, yoga), enquiring into participants´ experiences of these practices, review of homework, and teaching/discussion of cognitive-behavioural skills. In line with the previous MBCT trials, an adequate dose of MBCT is defined as participation in at least four of the eight MBCT group sessions. All group sessions are led by a licensed clinical psychologist with extensive experience in providing MBCT. No intervention is delivered to participants in the wait-list condition during the 8 week waiting period but will receive MBCT after this period. All particpants in the study are followed for 2 years to monitor depression recurrence. This is achieved through visits to researchers 12 and 24 months after treatment ended where mental status and history is assessed along with other outcomes and processes measured in the study.

Added 01/07/2020:
Our aim was to run Mindfulness-Based Cognit

Primary Outcome(s)

1. Cognitive reactivity is measured at pre/post treatment, and 1 and 2 year follow-up using:
1.1. Leiden Index of Depression Sensitivity-Revised (LEIDS-R)
1.2. Mood-linked changes in dysfunctional attitudes that are measured with the Dysfunctional Attitudes Scales (DAS); added 19/08/2019: only measured at pre/post treatment
1.3. Repeated assessment of negative thoughts during a 6 day experience sampling period via smartphone
2. Depressive rumination is measured pre/post treatment, and at 1 and 2 year follow-up:
2.1. The brooding and reflective pondering scales of the Ruminative Responses Scales (RRS).
2.2. Rumination Induction task following mood-induction; added 19/08/2019: only measured at pre/post treatment
2.3. Repeated assessment of ruminative thinking during a 6 day experience sampling period via smart-phone 3. Habitual characteristics of negative and ruminative thoughts are measured pre/post treatment, and at 1 and 2 year follow-up using:
3.1. Habit Index of Negative Thinking (HINT) that measures habitual characteristics of negative thoughts.
3.2. Repeated assessment of habitual characteristics of negative and ruminative thinking during a 6 day experience sampling period via smartphone
4. Relapse or recurrence of major depression episodes are assessed with the MINI 5.0 (according to the DSM-IV criteria) that is a semi-structured clinical interview (including additional questions on age of onset, time of episodes) as well as the second version of the Beck Depression Inventory measured pre/post treatment, and at 1 and 2 year follow-up

Secondary Outcome(s)

Measures relevant to depression risk and/or relapse/recurrence are assessed and are used to examine mediation and moderation of treatment outcome. The following measures are used (including assessment points):
1. Kentucky Inventory of Mindfulness Skills (KIMS) that measures four different facets of mindfulness skills (assessed at pre/post treatment, 1 and 2 year follow-up)
2. The Self-Compassion Scale (SCS) that measures self-kindness, self-judgement and common humanity and has been used in previous MBCT studies (assessed at pre/post treatment, 1 and 2 year follow-up)
3. Treatment history will be assessed in a short interview constructed by researchers. Questions focus on participants’ history of cognitive behavioural therapy and pharmacotherapy with anti-depressives (assessed at pre/post treatment, 1 and 2 year follow-up)
4. The Snaith-Hamilton Pleasure Scale (SHAPS) will be used to measure anhedonia (assessed at pre/post treatment, 1 and 2 year follow-up)
5. The Positive and Negative Affect Scale (PANAS) will be used to measure state negative and positive affect (assessed at pre/post treatment, 1 and 2 year follow-up)
6. The Beck Anxiety Inventory (BAI) will be used to measure severity of symptoms of anxiety (assessed at pre/post treatment, 1 and 2 year follow-up)
7. The creature of Habit Scale (COHS) will be used to assess respondent’s general tendency to habitual behaviours (assessed at pre treatment)
8. The Fabolous Fruit Game (FFG) is a computerised outcome-devaluation tasks that taps peoples ability to alter behaviour when an outcome’s value changes. The task measures goal-directed vs. habit-related behaviour control (assessed at pre treatment).
9. The Childhood Traumatic Event Scale (TES) is a self-report questionnaire and is used to assess history of traumatic events (assessed at pre treatment)
10. The Difficulties in Emotion Regulation Scale (DERS) and Emotion Reactivity Scale (ERS) will be used to measure emotion regulation ability and emotional reactivity (assessed at pre treatment)
11. The Depression Stigma Scale (DSS) will be used to measure peoples stigma associated with depression (assessed at pre treatment)
12. Daily mood ratings during a six-day experience sampling period via smart-phones (assessed at pre/post treatment, 1 and 2 year follow-up)

Secondary ID(s)

173803-051

Source(s) of Monetary Support

The Icelandic Research Fund, University of Iceland

Ethics review

Status:
Approval date:
Contact:

The Icelandic National Bioethics Committee, 05/12/2017, ref:17-235

Results

• Results available: Yes
• Date Completed: 01/08/2022