NCT07362511

Brief Summary

In the current study we aim to investigate the feasibility, acceptability, and effectiveness of ImRs offered by mental health assistants within primary care to reduce depressive symptoms. In a single-case experimental design (SCED) study, the following hypotheses will be tested:

  1. 1.ImRs results in a reduction of depressive symptoms compared to baseline, and this reduction lasts up to six months.
  2. 2.Patients with complaints of depressive symptoms find ImRs an acceptable form of intervention when offered by mental health assistants within a general practice setting.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
Dec 2025Jan 2027

Study Start

First participant enrolled

December 1, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

December 16, 2025

Last Update Submit

January 14, 2026

Conditions

Keywords

Imagery RescriptingDepressionPrimary care

Outcome Measures

Primary Outcomes (3)

  • Depressive symptom severity

    Depressive symptom severity is assessed with the PHQ-2 (Kroenke et al., 2003). The PHQ-2 consists of the first two items of the PHQ-9 and measures the frequency of depressed mood and anhedonia in the past week. Scores range from 0-6 and higher scores mean more depressive symptoms.

    16-18 weeks, twice a week

  • Self-esteem

    Self-esteem will be measured with a single question "How have you felt about yourself in the past week?" Participants rate this question on a scale from -100 (very negative) to +100 (very positive).

    16-18 weeks, twice a week

  • Dysfunctional core beliefs

    Participants will formulate these negative beliefs about themselves or the world/other people together with the mental health assistant during the first session and then rate how convincing these beliefs are on a scale from 0 (not at all convincing) -100 (very convincing).

    16-18 weeks, twice a week + 3 month and 6 month follow-up

Secondary Outcomes (4)

  • Hospital Anxiety and Depression Scale

    Baseline, pre-treatment, 4-weeks post-treatment, 3 month follow-up, 6 month follow-up

  • Rosenberg Self-Esteem Scale

    Baseline, pre-treatment, 4-weeks post-treatment, 3 month follow-up, 6 month follow-up

  • Suicidal thoughts

    Baseline, pre-treatment, 4-weeks post-treatment, 3 month follow-up, 6 month follow-up

  • Emotional memory

    Pre-treatment, 4-weeks post-treatment, 3 month follow-up, 6 month follow-up

Other Outcomes (1)

  • Acceptability

    4- weeks post-treatment

Study Arms (1)

Imagery Rescripting

EXPERIMENTAL

The ImRs will follow the protocol as developed by Arntz and Weertman (1999), that was tailored for the primary care setting. The total of sessions will be set at 6. In session 1, the patient and therapist will create a list of core beliefs and memories to be rescripted. Session 1 will take place before the baseline phase, allowing us to assess core beliefs prior to the intervention. In session 2-6, one negative emotional memory is selected and rescripted (45 minutes per session). If necessary, a memory can be rescripted twice. In session 2-3 the therapist enters the image and rescripts the memory, whereas in session 4-6 the patient adult-self enters the image and rescripts the memory. If patients are uncomfortable doing so, session 4 can still be guided by the therapist.

Behavioral: Imagery Rescripting

Interventions

During ImRs, the patient brings a negative memory to mind and changes, together with the therapist, the outcome of the memory into a more positive

Also known as: ImRs
Imagery Rescripting

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Main complaint of depressive feelings, as indicated by both the mental health assistant and the patient.
  • HADS score for the depression subscale ≥ 11.
  • Ability to understand, read, write and speak Dutch or English.
  • Age between 18 and 70.
  • Willingness to participate in the study and treatment.

You may not qualify if:

  • Acute suicide risk (BDI-II-item9 score of 3).
  • If the mental health assistant suspects that the patient may have a primary diagnosis of bipolar disorder, psychosis, substance use disorder, low IQ, or if the patient suffers from serious neurological problems such as dementia, then the patient is not included. There will not be a formal assessment of a primary diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UvA Huisartsen

Amsterdam, North Holland, 1018VZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Mood DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Central Study Contacts

Lotte Stemerding

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A multiple-baseline case series design will be used. All participants will first complete a baseline phase without intervention, and then undergo 10 weeks of Imagery Rescripting intervention (5 sessions). Participants are randomized to different waitlist (baseline) durations (2, 3 or 4 weeks), and intervention effectiveness is evaluated by comparing the change over time of bi-weekly self-reported depressive symptoms, self-esteem, and core beliefs.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 16, 2025

First Posted

January 23, 2026

Study Start

December 1, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Due to privacy regulations we are not allowed to share individual patient data.

Locations