Major Depressive DiorderIMPACT MADENCT07362511
Imagery Rescripting in Primary Care
A study testing Imagery Rescripting in people with Major Depressive Diorder and Low Self-Esteem, run by University of Amsterdam at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Diorder, Low Self-Esteem, Mood Disorders
- What is being tested?
- Imagery Rescripting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
UvA Huisartsen
Amsterdam, North Holland, 1018VZ
Anna Kastelein, 0031205252878, a.m.kastelein@uva.nl
About this study
Official title: Imagery Rescripting Within Primary Care to Manage Depression: A Single-Case Experimental Design
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:
- ImRs results in a reduction of depressive symptoms compared to baseline, and this reduction lasts up to six months.
- 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.
Read the detailed description
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.
- Conditions
- Major Depressive Diorder, Low Self-Esteem, Mood Disorders
- Being tested
- Imagery Rescripting
- Keywords
- Imagery Rescripting, Depression, Primary care
- Medical subject headings
- Mood Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imagery RescriptingBehavioural
Also called ImRs
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Imagery Rescripting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 16-18 weeks, twice a week + 3 month and 6 month follow-up
Secondary outcomes (4)
Hospital Anxiety and Depression Scale
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.
Measured: Baseline, pre-treatment, 4-weeks post-treatment, 3 month follow-up, 6 month follow-up
Rosenberg Self-Esteem Scale
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).
Measured: Baseline, pre-treatment, 4-weeks post-treatment, 3 month follow-up, 6 month follow-up
Suicidal thoughts
Suicidal thoughts are measured using item 9 of Beck's depression inventory (BDI-II)
Measured: Baseline, pre-treatment, 4-weeks post-treatment, 3 month follow-up, 6 month follow-up
Emotional memory
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.
Measured: Pre-treatment, 4-weeks post-treatment, 3 month follow-up, 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Dec 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DiorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Amsterdam
- Sponsor type
- University, hospital or other
- Collaborators
- UvA Huisartsen
- Responsible party
- Principal investigator, Lotte Stemerding, University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362511
- Sponsor's protocol ID
- FMG-11030
- Acronym
- IMPACT MADE
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to privacy regulations we are not allowed to share individual patient data.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imagery Rescripting Within Primary Care to Manage Depression: A Single-Case Experimental Design
- ClinicalTrials.gov ID
- NCT07362511
- Acronym / sponsor ID
- IMPACT MADE / FMG-11030
- Conditions
- Major Depressive Diorder, Low Self-Esteem, Mood Disorders
- Keywords
- Imagery Rescripting, Depression, Primary care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of AmsterdamUniversity, hospital or other
- Collaborators
- UvA Huisartsen
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- ImRs results in a reduction of depressive symptoms compared to baseline, and this reduction lasts up to six months.
- 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Imagery Rescripting | Experimental | Behavioral: Imagery RescriptingThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imagery RescriptingAlso: ImRsDuring ImRs, the patient brings a negative memory to mind and changes, together with the therapist, the outcome of the memory into a more positive | Behavioural | Imagery Rescripting |
Primary outcome
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.
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).
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).
4 secondary outcomes
Hospital Anxiety and Depression Scale
Time frame: Baseline, pre-treatment, 4-weeks post-treatment, 3 month follow-up, 6 month follow-up
Rosenberg Self-Esteem Scale
Time frame: Baseline, pre-treatment, 4-weeks post-treatment, 3 month follow-up, 6 month follow-up
Suicidal thoughts
Time frame: Baseline, pre-treatment, 4-weeks post-treatment, 3 month follow-up, 6 month follow-up
Emotional memory
Time frame: Pre-treatment, 4-weeks post-treatment, 3 month follow-up, 6 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No. Due to privacy regulations we are not allowed to share individual patient data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imagery Rescripting in people with Major Depressive Diorder and Low Self-Esteem, run by University of Amsterdam at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lotte Stemerding (0031614401653, l.e.stemerding@uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptom severity (time frame: 16-18 weeks, twice a week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.