- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07362511
Imagery Rescripting in Primary Care (IMPACT MADE)
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lotte Stemerding
- Phone Number: 0031614401653
- Email: l.e.stemerding@uva.nl
Study Locations
-
-
North Holland
-
Amsterdam, North Holland, Netherlands, 1018VZ
- Recruiting
- UvA Huisartsen
-
Contact:
- Anna Kastelein
- Phone Number: 0031205252878
- Email: a.m.kastelein@uva.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Imagery Rescripting
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
16-18 weeks, twice a week
|
|
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).
|
16-18 weeks, twice a week
|
|
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).
|
16-18 weeks, twice a week + 3 month and 6 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
|
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).
|
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
|
Suicidal thoughts are measured using item 9 of Beck's depression inventory (BDI-II)
|
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
|
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. |
Pre-treatment, 4-weeks post-treatment, 3 month follow-up, 6 month follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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".
|
4- weeks post-treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMG-11030
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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