Imagery Rescripting in Primary Care (IMPACT MADE)

University of Amsterdam

Status: Enrolling

Conditions: Low Self-Esteem; Mood Disorders; Major Depressive Diorder

Treatments: Behavioral: Imagery Rescripting

Study type: Interventional

Funder types: Other

Identifiers

NCT07362511

FMG-11030

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Imagery Rescripting

Experimental group

Description:

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.

Treatment:

Behavioral: Imagery Rescripting