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Improving treatment of severe major depressive disorder by reducing negative future-oriented mental imagery

Improving treatment of severe major depressive disorder by reducing negative future-oriented mental imagery - PROFIT-project

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56695
Enrollment
50
Registered
2024-03-29
Start date
2024-06-03
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Interventions

Future-oriented imaginary rescripting (ImRes): ImRes is an imagery technique in which patients change a negative image in a positive way. These negative future-oriented mental images (for example im

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18 years or older ; 2) Meet DSM-5 criteria for major depressive disorder; 3) Be able to understand questionnaires and study information letter; 4) In case of medication use: are stable on medication for six weeks or longer; 5) Presence of at least one negative future-oriented mental imagery, which causes distress.

Exclusion criteria

Exclusion criteria: 1) Psychosis and/or bipolarity 2) Severe cognitive impairment (e.g., mental retardation) as evidenced by clinical impression; 3) Current EMDR or imagery rescripting therapy 4) Other circumstances that might affect participation (e.g., severe medical disorder, relocation).

Design outcomes

Primary

MeasureTime frame
The primary objective of this pilot study is to test the acceptability of imagery rescripting.

Secondary

MeasureTime frame
• To measure feasibility, we will assess recruitment/admission ratio, dropout and (serious) adverse events. • To estimate the variance of effects, group effects on depressive symptoms measured with the BDI-II and SCID-5-s (module A)will be tested at post-treatment and 3 months follow-up (corrected for baseline). • Screening for other disorders (SCID-5 Dutch version); sections on depressive disorder, substance use disorder, psychotic disorders, anxiety disorders andposttraumatic disorder • Behavioral activation (Behavioral Activation for Depression Scale - Dutch version) • Affect: The International Short-form of the Positive and Negative Affect Schedule (I-PANAS-SF) • Quality of life (EQ-5D-5L) • Anxiety measured with Generalized Anxiety Disorder scale (GAD-7) • Vividness and likelihood of prospective positive and negative scenarios with prospective imagery task (PIT) • Ratings of mental images on emotions (sad, guilty, ashamed, anxious, angry, helpless), vivedness, uncontrollability, distress and core belief, using 0-100 visual analog scales ranging • Monitoring of treatment as usual will be asked to the therapist at baseline (*which treatment (including medication + dose; possible in-patient treatment) does the patient receive currently?') and at posttreatment and follow-up ("which therapy has the patient received in the past 6/12 weeks (including medication + dose; possible in-patient treatment)?")

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 3, 2026