We propose to study the role of rumination (moderation and mediation) in the effect of MBCT on depressive symptoms and risk factors for relapse in crMDD patients, by means of repeated questionnaire measures and an innovative on-line behavioral task…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our primary objective is to understand the role of rumination in depressive
symptoms changes in chronic and recurrent MDD patients as a result of MBCT
treatment. Therefore we will assess rumination and depressive symptoms
repeatedly during MBCT and will investigate the effect of MBCT on a novel,
on-line behavioural task of rumination, namely the Breathing Focus Task (BFT).
We will also use questionnaires to assess rumination and depressive symptoms.
Secondary outcome
Our secondary aim is to elucidate the cognitive mechanisms concerning negative
inhibitory processing in working memory and behaviour that possibly underlie
depression and rumination and the effect of MBCT. For this, we will look at
aversive PIT and evaluate its relation with depression. We will also test
emotion specific working memory function and evaluate its relation with
rumination. Additionally, the effect of MBCT on these parameters will be
assessed.
For this we will use the Pavlovian-Instrumental Transfer (PIT) task and the
Working Memory Update/Ignore Emotion Task (WMUIET), together with
questionnaires and the BFT task to assess rumination.
Background summary
Depression is highly prevalent and is ranked by the WHO as the number one
contributor to disability worldwide. The highly recurrent nature of the
disorder contributes greatly to the burden of Major Depressive Disorder (MDD)
and with every new depressive episode, outcome prospective worsen. Mindfulness
Based Cognitive Therapy (MBCT) is an effective treatment to reduce relapse
rates and (residual) symptoms in MDD. However, the mechanisms underlying this
effect are far from clear.
Elucidating these mechanisms will provide insight in the existing individual
differences in effectiveness of MBCT. Consequently, this insight will help to
improve effectiveness of treatment and possibly even personalize treatment
regimes. We will look into two factors that are thought to be important in the
effect of MBCT on depression: rumination and the processing of external
negative information.
Study objective
We propose to study the role of rumination (moderation and mediation) in the
effect of MBCT on depressive symptoms and risk factors for relapse in crMDD
patients, by means of repeated questionnaire measures and an innovative on-line
behavioral task (Breathing Focus Task) before, after and during MBCT treatment.
Additionally, we will investigate the extent and role of abnormally processed
negative information in crMDD patients, using two innovative, task-based
neurocognitive measures both before and after treatment, focusing on negativity
in working memory processing and aversive inhibition.
Thus, the objectives are to:
1. Replicate beneficial effects of MBCT on depressive symptoms, rumination and
quality of life in patients with recurrent or chronic major depression.
2. Test moderating and mediating effects of rumination:
2.1.1. Does rumination on baseline moderate the effect of MBCT versus TAU on
depressive symptoms in patients with moderate to severe depressive symptoms?
2.1.2. Does rumination mediate the effect of MBCT on depressive symptoms in
recurrent depressed and chronic depressed patients?
3. Assess the relation between aversive inhibition and emotion-specific working
memory on the one hand and rumination and depressive symptoms before MBCT on
the other.
4. Assess whether MBCT changes aversive inhibition and emotion-specific working
memory in patients with crMDD.
5. Assess whether (changes in) aversive inhibition and emotion specific working
memory moderate and/or mediate the effect of MBCT on depressive symptoms.
Study design
Waitlist controlled trial, where division in the two groups is determined by
the sign-up date for the start of the training, as usual in clinical routine.
Study burden and risks
All subjects will fill in questionnaires and perform three tasks. Patients will
be divided in two groups, who both do the same tasks and questionnaires, but
have a different amount of appointments:
For group 1, behavioural tasks and questionnaires will be administered at 3
moments: once before (2,5 hours), once during (50 min) and once after the MBCT
(2,5 hours). In addition, short questionnaires will be filled in by the subject
after each weekly MBCT session (8x 10 mins = 1 hr 20 min). This adds up to an
extra time investment of 7 hours and 10 minutes for participants in group 1.
Subjects in group 2 will complete the same behavioural task measurements in
three appointments before MBCT (2x2,5 hours + 50 min = 5 hr 50 ) and will fill
in the short questionnaires weekly (8x 10 mins = 1 hr 20 min) during their
waiting period. During MBCT they follow the same procedure as Group 1 (8x10 min
+ 1x 50 min = 2 hr 10) . The measurement moment after MBCT will consist of less
tasks for this group (50 mins). This adds up to 10 hr 10 min.
*Participants from ProPersona will be asked to fill in questionnaires and to
perform a breathing task (BFT - see below) during their appointments. The
computer tasks will not be administered. Therefore, the time investment for
ProPersona participants in group 1 adds up to 3 hours 50 min and to 6 hours and
50 min in group 2.
Healthy controls will be invited to one measurement moment (3 hours) after a
phone call of approximately 30 minutes, for a total of 3,5 hours.
The used questionnaires are:
• Rumination: Rumination is measured with the extended version of the
Ruminative Response Scale (RRS; F. Raes & Hermans, 2007; Treynor, Gonzalez, &
Nolen-Hoeksema, 2003). The total score and the 5-item subscale
*brooding* (Schoofs, Hermans, & Raes, 2010) will be used.
• Repetitive Negative Thinking: The Perseverative Thinking Questionnaire (PTQ;
Ehring et al., 2011) is used to assess repetitive negative thinking before and
after MBCT/intermediate period of 8 weeks. The PTQ consists of 15-items.
• Depressive symptoms: Inventory of Depressive Symptomatology Self-Report
(IDS-SR; Rush, Gullion, Basco, Jarrett, & Trivedi, 1996) is a 30-items measure
of depressive symptom severity. During the weekly measures the 16-item Quick
Inventory of Depressive Symptomatology Self-Report (QIDS-SR) will be used.
• Mindfulness skills: Mindfulness skills will be assessed with the 24-item Five
Facet Mindfulness Questionnaire - Short Form (FFMQ-SF; Bohlmeijer, ten
Klooster, Fledderus, Veehof, & Baer, 2011). The subscale non-judging of inner
experience, consisting of 6 items, is used to assess this facet of mindfulness
skills during the weekly measures.
• Anxiety symptoms: Anxiety symptoms will be assessed with the Spielberger
State-Trait Anxiety Inventory (STAI; Spielberger, 1971).The STAI-trait scale
consists of 20 items and is scored on a 4-point-lickert scale.
• General well-being: The general well-being will be assessed with the Outcome
Questionnaire (OQ; Lambert et al., 1996). The OQ consists of 45 items.
• Self-compassion: Self-compassion will be assessed with the 12-items Self
Compassion Scale-Short Form (SCS-SF; Neff, 2003; Filip Raes, Pommier, Neff, &
Van Gucht, 2011).
The tasks consist of:
• Breathing Focus Task (BFT), 20 minutes: participants are asked to focus on
their breathing and to once in a while indicate whether they are focussing on
their breath, or are distracted. If they are distracted, they are asked whether
it is by a positive, negative or neutral thought.
• Pavlovian-Instrumental Transfer (PIT) task, 30 minutes: participants are
asked to collect mushrooms on the computer, where mushrooms have either a
reward or loss of money. They are asked to collect the mushroom with the reward
and avoid mushrooms with a loss.
• Working Memory Update/Ignore Emotion Task (WMUIET), 40 minutes: participants
are asked to remember faces that are shown on the computer screen, which either
have sad or neutral facial expressions.
Reinier Postlaan 4
Nijmegen 6500 HB
NL
Reinier Postlaan 4
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
• Age: 18+ years old
• Chronic or recurrent major depressive disorder (MDD) diagnosis , both with
current episode or in remission
• Able to give informed consent
Exclusion criteria
• Impossibility to obtain a valid informed consent
• Insufficient comprehension of the Dutch language
• Physical, cognitive, or intellectual impairments interfering with
participation, such as deafness, blindness, or sensorimotor handicaps
• Formerly/currently involved in MBCT or MBSR training
• Meets criteria for bipolar disorder, schizophrenia, schizophreniform
disorder, schizoaffective illness or anorexia nervosa.
• Current psychosis
• High level of suicidality
• Drug or alcohol addiction in the past 6 months
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL68398.091.18 |
Other | NL7842 |
OMON | NL-OMON24838 |