Clinical trial NCT06454695: Improving Treatment of Major Depressive Disorder by Reducing Negative Future-Oriented Mental Imagery
Official title: Improving Treatment of Severe Major Depressive Disorder by Reducing Negative Future-Oriented Mental Imagery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Mental Imagery
Cognitive Behavioral Therapy
Keywords: Imagery rescripting
Prospective negative mental images
Depression
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: GGZ Eindhoven (participating site)
name: Mental Care Group (i.e., HSK group and Mentaal Beter; participating sites)
name: Praktijk V (participating site)
name: ZonMw (funding)
name: Depressie Vereniging (patient association)
name: MIND (civil society organization)
First posted: 2024-06-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The design is a randomized, controlled, pragmatic, multicenter, pilot trial. Adult patients with major depressive disorder will be randomized (1:1) to either treatment as usual (TAU) only, or TAU with future-oriented imagery rescripting.
Primary purpose: TREATMENT

Brief summary: Patients with major depressive disorder (MDD) often do not sufficiently benefit from treatment. That is, around 50% of patients with MDD do not respond to treatment and 20-30% only achieve partial remission. Future-oriented negative mental imagery (e.g., mental images of suicide or own funeral) is likely an important maintaining factor of depression and initial studies in depression indicate that targeting mental imagery with 'imagery rescripting' could be a promising therapeutic technique to reduces depressive symptomatology by targeting these images directly that elicits strong affects/emotions and depressive symptomatology.

Before testing the (cost)effectiveness of future-oriented imagery rescripting to treatment as usual (TAU), a pilot study is needed to examine 1) the acceptability of the intervention, 2) the feasibility of the study, and 3) the variance of effect on reducing depressive symptomatology that can serve as estimate of the sample size for a follow-up randomized controlled trial (RCT).

A multicenter pilot RCT with a mixed factorial design with three time points (i.e., baseline, post-treatment, and follow-up of 3 months) will test 50 patients with MDD who will be randomly allocated to future-oriented imagery rescripting plus TAU or TAU only.

The sample consists of adult patients of 18 years or older with an MDD diagnosis.

All patients in this pilot study receive TAU, which involves a combination of pharmacological and psychological interventions. Half of the patients will also receive 3-5 sessions of future-oriented imagery rescripting (ImRes). In each ImRes session, patients identify an image of a autobiographic catastrophic future event (e.g., catastrophic images of future suicide or the loss of work or a loved one). They are subsequently asked to "rescript" this image into a more benign one.

The primary aim of this pilot study is to determine the acceptability of the intervention. The secondary aims are to elucidate factors that may facilitate or hinder the feasibility of the follow-up RCT (e.g., recruitment process) and to estimate the variance of the effect on reduction of depressive symptomatology, which informs the sample size calculation of the follow-up RCT. To study acceptability, the investigators assess depressive symptoms (BDI-II and BADS) and treatment satisfaction (SRS and CSQ-8). To measure feasibility, the investigators will assess recruitment/admission ratio, dropout and (serious) adverse events. Finally, to estimate the variance of effects, group effects on the BDI-II will be tested at post-treatment and follow-up (corrected for baseline).

Imagery rescripting on negative memories has already proven effective and safe in MDD patients. There is no known major risk associated with study participation. Patient burden comprises an online or phone-based screening interview of maximum 60 minutes and several questionnaires. Participants receive a reimbursement of €25,- after study completion (i.e., after follow-up assessment). The project will contribute to improving the care for patients with MDD. If the results show that the intervention is feasible and acceptable, this pilot study will inform the setup of the main RCT on the (cost)effectiveness of the intervention (ZonMW).


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older;
* Meet DSM-5 criteria for major depressive disorder;
* Presence of 1-3 negative future-oriented mental images, which cause distress;
* Be able to understand questionnaires and study information letter;
* In case of medication use: are stable on medication for six weeks or longer.

Exclusion Criteria:

* Current or history of psychotic disorder;
* Current or history of bipolar disorder;
* Severe cognitive impairment (e.g., mental retardation) as evidenced by educational records, parental report and/or clinical impression;
* Current EMDR or imagery rescripting therapy;
* Other circumstances that might affect participation (e.g., severe medical disorder, relocation).

Primary outcomes:
measure: Beck Depression Inventory (Acceptability)
timeFrame: From baseline to the end of the study at follow-up (total of 18 weeks).
measure: Behavioral Activation for Depression Scale (Acceptability)
timeFrame: From baseline to the end of the study at follow-up (total of 18 weeks).
measure: Session Rating Scale (Treatment satisfaction)
timeFrame: During treatment intervention (total of 5 weeks)
measure: Client satisfaction Questionnaire (treatment satisfaction)
timeFrame: After the study intervention and at follow-up
Secondary outcomes:
measure: Recruitment/admission ratio (Feasibility)
timeFrame: From enrollment to the end of the study at follow-up (total of 18 weeks).
measure: Dropout (Feasibility)
timeFrame: From enrollment to the end of the study at follow-up (total of 18 weeks).
measure: (serious) adverse events (Feasibility)
timeFrame: From enrollment to the end of the study at follow-up (total of 18 weeks).
measure: Variance of effect
timeFrame: From enrollment to the end of the study at follow-up (total of 18 weeks).
Other outcomes:
measure: Structured Clinical Interview for DSM-5
timeFrame: Screening
measure: Positive and Negative Affect Schedule
timeFrame: From baseline to the end of the study at follow-up (total of 18 weeks).
measure: 5-level EQ-5D
timeFrame: From baseline to the end of the study at follow-up (total of 18 weeks).
measure: Generalized Anxiety Disorder
timeFrame: From baseline to the end of the study at follow-up (total of 18 weeks).
measure: Rating of mental images
timeFrame: From baseline to the end of the study at follow-up (total of 18 weeks).
measure: Prospective Imagery Task
timeFrame: From baseline to the end of the study at follow-up (total of 18 weeks).
measure: Monitoring of Treatment as Usual
timeFrame: From baseline to the end of the study at follow-up (total of 18 weeks).
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC (location AMC)
state: Noord-Holland
Study officials:
References: