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

NCT06454695 | Recruiting DMC

• 2 other identifiers: 2023.0973NL85551.018.23
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Major Depressive Disorder; Mental Imagery; Cognitive Behavioral Therapy

Keywords

Imagery rescripting; Prospective negative mental images; Depression

Outcome Measures

Primary Outcomes (4)

• Beck Depression Inventory (Acceptability)

  Beck Depression Inventory (BDI-II) for depressive symptoms, consisting of 21 questions with scores between 0-3 whereby a higher score indicates a worse outcome.

  From baseline to the end of the study at follow-up (total of 18 weeks).

• Behavioral Activation for Depression Scale (Acceptability)

  Behavioral Activation for Depression Scale (BADS-NL) for depressive symptoms, consisting of 25 questions with scores between 0-6 whereby a higher score indicates a worse outcome.

  From baseline to the end of the study at follow-up (total of 18 weeks).

• Session Rating Scale (Treatment satisfaction)

  Session Rating Scale (SRS) is filled in during the intervention, consisting of 4 visual analogue scales ranging between 0-100.

  During treatment intervention (total of 5 weeks)

• Client satisfaction Questionnaire (treatment satisfaction)

  Client Satisfaction Questionnaire (CSQ-8), consisting of 8 questions whereby the answers ranged from totally disagree to totally agree

  After the study intervention and at follow-up

Secondary Outcomes (4)

• Recruitment/admission ratio (Feasibility)

  From enrollment to the end of the study at follow-up (total of 18 weeks).

• Dropout (Feasibility)

  From enrollment to the end of the study at follow-up (total of 18 weeks).

• (serious) adverse events (Feasibility)

  From enrollment to the end of the study at follow-up (total of 18 weeks).

• Variance of effect

  From enrollment to the end of the study at follow-up (total of 18 weeks).

Other Outcomes (7)

• Structured Clinical Interview for DSM-5

  Screening

• Positive and Negative Affect Schedule

  From baseline to the end of the study at follow-up (total of 18 weeks).

• 5-level EQ-5D

  From baseline to the end of the study at follow-up (total of 18 weeks).

Study Arms (2)

Treatment as Usual

ACTIVE COMPARATOR

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

Other: Treatment as Usual

Imagery Rescripting

EXPERIMENTAL

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).

Behavioral: Future-oriented imagery rescripting; Other: Treatment as Usual

Interventions

Future-oriented imagery rescripting 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.

Imagery Rescripting

Treatment as Usual OTHER

Psychotherapy and/or medication

Imagery Rescripting; Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• GGZ Eindhoven (participating site): collaborator
• Mental Care Group (i.e., HSK group and Mentaal Beter; participating sites): collaborator
• Praktijk V (participating site): collaborator
• ZonMw (funding): collaborator
• Depressie Vereniging (patient association): collaborator
• MIND (civil society organization): collaborator

Study Sites (1)

Amsterdam UMC (location AMC)

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Evi-Anne van Dis, PhD

CONTACT

+31 630485261; profitstudie@amsterdamumc.nl

Mariejean Albers, MSc

CONTACT

+31 630485261; profitstudie@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Most questionnaires will be self-reported via Castor EDC. Only a screening interview will be administered by researchers online.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof dr Claudi Bockting

Model Details: 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.

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 12, 2024
• Study Start: June 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)