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NCT Number: NCT07362511

Imagery Rescripting in Primary Care

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. ImRs results in a reduction of depressive symptoms compared to baseline, and this reduction lasts up to six months. 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.

Participants will wait for 2-4 weeks and then receive 5 sessions of ImRs over a period of 10 weeks. During these sessions, negative memories related to their depressed feelings are rescripted.

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Key information

Conditions

Major Depressive Diorder Behavior Behavioral Symptoms Depression Low Self-Esteem Mental Disorders Mood Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UvA Huisartsen

Amsterdam, North Holland, 1018VZ, Netherlands

Location status: Recruiting

Location contact

Anna Kastelein

CONTACT

[email protected]

0031205252878

About this study

The study consists of a multiple-baseline case series in which the effectiveness and feasibility of Imagery Rescripting as a therapeutic technique will be investigated within primary care, with the aim of reducing depressive symptoms. The intervention will be provided by the mental health assistants (POH-GGZ) at the GP practice that is linked to the University of Amsterdam (Huisartsenpraktijk UvA). These mental health assistant have been trained in Imagery Rescripting. In the study, participants are randomly assigned to a baseline condition of 2-4 weeks, and a subsequent intervention condition of 10 weeks. During the intervention, all patients receive five sessions of Imagery Rescripting (45 minutes per session). Throughout these 12-14 weeks, and for 4 weeks after, participants complete bi-weekly (i.e., twice per week) measurements. The total number of bi-weekly measurements is thus 32-36, depending on the baseline condition that participants are randomized to. In addition, there will be 5 longer questionnaires, including a 3 and 6-month follow-up. Participants that are invited to the study but that do not want to participate will receive care as usual by the mental health assistant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Imagery Rescripting

Behavioral

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

Other names: ImRs

Primary outcomes

  1. Depressive symptom severity

    Time frame: 16-18 weeks, twice a week

    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.

  2. Self-esteem

    Time frame: 16-18 weeks, twice a week

    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).

  3. Dysfunctional core beliefs

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

    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).

Secondary outcomes

  1. Hospital Anxiety and Depression Scale

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

    Measures depressive and anxious symptoms on a 14 item scale (Zigmond & Snaith, 1983). Scores range from 0-21 per scale (Anxiety and Depression) and higher scores reflect higher symptom severity.

  2. Rosenberg Self-Esteem Scale

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

    Measures self-esteem with 10 items scored on a 4-point scale, scores range from 0 to 30, and higher scores reflect higher self-esteem (Rosenberg, 1965).

  3. Suicidal thoughts

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

    Suicidal thoughts are measured using item 9 of Beck's depression inventory (BDI-II)

  4. Emotional memory

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

    We will measure the following characteristics of the reported memories that will be rescripted: Vividness, Emotional Intensity, Emotional Impact, Intrusivity.

    These characteristics will be assessed with subscales of the Memory Experiences Questionnaire (MEQ; Vividness and Emotional Intensity) and two added subscales (Emotional Impact, Intrusivity). These measures are based on a previous study that these indices of a negative emotional memory related to depression scores (Stemerding et al., 2025). Each aspects is scored from 1-5 and higher scores mean stronger vividness, emotional intensity, emotional impact and intrusiveness.

Other outcomes

  1. Acceptability

    Time frame: 4- weeks post-treatment

    We assess the acceptibility of the intervention using six questions that are formulated to measure how the participants feel about the intervention. An example is "To what extent would you recommend this intervention to a friend or family member that experiences symptoms similar to yours?". These items are assessed on a 9 point likert scale ranging from "not at all" to "very much".

Study contacts

Contact information is provided by the study sponsor or research team.

Lotte Stemerding

CONTACT

[email protected]

0031614401653

Sponsors and collaborators

Lead sponsor

University of Amsterdam

Other

Collaborators

  • UvA Huisartsen

Registry information

Official study title

Imagery Rescripting Within Primary Care to Manage Depression: A Single-Case Experimental Design

Acronym: IMPACT MADE

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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