Improving Treatment of Major Depressive Disorder by Reducing Negative Future-Oriented Mental Imagery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-11-01

Brief Summary

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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).

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Detailed Description

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Conditions

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Major Depressive Disorder Mental Imagery Cognitive Behavioral Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Most questionnaires will be self-reported via Castor EDC. Only a screening interview will be administered by researchers online.

Study Groups

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Treatment as Usual

Participants receive Treatment as Usual (TAU) for their depression (i.e., psychotherapy and/or medication).

Group Type ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type OTHER

Psychotherapy and/or medication

Imagery Rescripting

Participants receive Treatment as Usual (TAU) for their depression (i.e., psychotherapy and/or medication) plus 3-5 future-oriented imagery rescripting therapy (45 minutes weekly sessions).

Group Type EXPERIMENTAL

Future-oriented imagery rescripting

Intervention Type BEHAVIORAL

In this pilot study, in the screening phase, negative or catastrophic future-oriented images will be explored for all patients, including ratings of distress. The future-oriented imagery rescripting consists of 3-5 sessions; each image will be treated in one session, starting with the image that causes highest distress. The protocol is largely based on Hackmann (1998), with minor adaptations from other protocols.

Treatment as Usual

Intervention Type OTHER

Psychotherapy and/or medication

Interventions

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Future-oriented imagery rescripting

In this pilot study, in the screening phase, negative or catastrophic future-oriented images will be explored for all patients, including ratings of distress. The future-oriented imagery rescripting consists of 3-5 sessions; each image will be treated in one session, starting with the image that causes highest distress. The protocol is largely based on Hackmann (1998), with minor adaptations from other protocols.

Intervention Type BEHAVIORAL

Treatment as Usual

Psychotherapy and/or medication

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No