Major Depressive DisorderPROFITNCT06454695
Improving Treatment of Major Depressive Disorder by Reducing Negative Future-Oriented Mental Imagery
A study testing Future-oriented imagery rescripting and Treatment as Usual in people with Major Depressive Disorder and Mental Imagery, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Patients with major depressive disorder (MDD) often do not sufficiently benefit from treatment. That is, around 50% of patients with MDD do not respond to treatment and 20-30% only achieve partial remission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder, Mental Imagery, Cognitive Behavioral Therapy
- What is being tested?
- Future-oriented imagery rescripting and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2024to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older;
- Meet DSM-5 criteria for major depressive disorder;
- Presence of 1-3 negative future-oriented mental images, which cause distress;
- Be able to understand questionnaires and study information letter;
- In case of medication use: are stable on medication for six weeks or longer.
Who cannot join
- Current or history of psychotic disorder;
- Current or history of bipolar disorder;
- Severe cognitive impairment (e.g., mental retardation) as evidenced by educational records, parental report and/or clinical impression;
- Current EMDR or imagery rescripting therapy;
- Other circumstances that might affect participation (e.g., severe medical disorder, relocation).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC (location AMC)
Amsterdam, North Holland, 1105 AZ
Dr. Evi-Anne van Dis, 020 8913600, e.a.m.vandis@amsterdamumc.nl
Drs. Mariejean Albers, +31 6 30 48 52 61, m.r.c.albers@amsterdamumc.nl
About this study
Official title: Improving Treatment of Severe Major Depressive Disorder by Reducing Negative Future-Oriented Mental Imagery
Patients with major depressive disorder (MDD) often do not sufficiently benefit from treatment. That is, around 50% of patients with MDD do not respond to treatment and 20-30% only achieve partial remission. Future-oriented negative mental imagery (e.g., mental images of suicide or own funeral) is likely an important maintaining factor of depression and initial studies in depression indicate that targeting mental imagery with 'imagery rescripting' could be a promising therapeutic technique to reduces depressive symptomatology by targeting these images directly that elicits strong affects/emotions and depressive symptomatology.
Before testing the (cost)effectiveness of future-oriented imagery rescripting to treatment as usual (TAU), a pilot study is needed to examine 1) the acceptability of the intervention, 2) the feasibility of the study, and 3) the variance of effect on reducing depressive symptomatology that can serve as estimate of the sample size for a follow-up randomized controlled trial (RCT).
Read more
A multicenter pilot RCT with a mixed factorial design with three time points (i.e., baseline, post-treatment, and follow-up of 3 months) will test 50 patients with MDD who will be randomly allocated to future-oriented imagery rescripting plus TAU or TAU only.
The sample consists of adult patients of 18 years or older with an MDD diagnosis.
All patients in this pilot study receive TAU, which involves a combination of pharmacological and psychological interventions. Half of the patients will also receive 3-5 sessions of future-oriented imagery rescripting (ImRes). In each ImRes session, patients identify an image of a autobiographic catastrophic future event (e.g., catastrophic images of future suicide or the loss of work or a loved one). They are subsequently asked to "rescript" this image into a more benign one.
The primary aim of this pilot study is to determine the acceptability of the intervention. The secondary aims are to elucidate factors that may facilitate or hinder the feasibility of the follow-up RCT (e.g., recruitment process) and to estimate the variance of the effect on reduction of depressive symptomatology, which informs the sample size calculation of the follow-up RCT. To study acceptability, the investigators assess depressive symptoms (BDI-II and BADS) and treatment satisfaction (SRS and CSQ-8). To measure feasibility, the investigators will assess recruitment/admission ratio, dropout and (serious) adverse events. Finally, to estimate the variance of effects, group effects on the BDI-II will be tested at post-treatment and follow-up (corrected for baseline).
Imagery rescripting on negative memories has already proven effective and safe in MDD patients. There is no known major risk associated with study participation. Patient burden comprises an online or phone-based screening interview of maximum 60 minutes and several questionnaires. Participants receive a reimbursement of €25,- after study completion (i.e., after follow-up assessment). The project will contribute to improving the care for patients with MDD. If the results show that the intervention is feasible and acceptable, this pilot study will inform the setup of the main RCT on the (cost)effectiveness of the intervention (ZonMW).
- Being tested
- Future-oriented imagery rescripting, Treatment as Usual
- Keywords
- Imagery rescripting, Prospective negative mental images, Depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Future-oriented imagery rescriptingBehavioural
In this pilot study, in the screening phase, negative or catastrophic future-oriented images will be explored for all patients, including ratings of distress. The future-oriented imagery rescripting consists of 3-5 sessions; each image will be treated in one session, starting with the image that causes highest distress. The protocol is largely based on Hackmann (1998), with minor adaptations from other protocols.
Treatment as UsualOther
Psychotherapy and/or medication
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | Active comparator | Participants receive Treatment as Usual (TAU) for their depression (i.e., psychotherapy and/or medication). Receives: Other: Treatment as Usual |
| Imagery Rescripting | Experimental | Participants receive Treatment as Usual (TAU) for their depression (i.e., psychotherapy and/or medication) plus 3-5 future-oriented imagery rescripting therapy (45 minutes weekly sessions). Receives: Behavioral: Future-oriented imagery rescripting; Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory (Acceptability)
Beck Depression Inventory (BDI-II) for depressive symptoms, consisting of 21 questions with scores between 0-3 whereby a higher score indicates a worse outcome.
Measured: From baseline to the end of the study at follow-up (total of 18 weeks).
Behavioral Activation for Depression Scale (Acceptability)
Behavioral Activation for Depression Scale (BADS-NL) for depressive symptoms, consisting of 25 questions with scores between 0-6 whereby a higher score indicates a worse outcome.
Measured: From baseline to the end of the study at follow-up (total of 18 weeks).
Session Rating Scale (Treatment satisfaction)
Session Rating Scale (SRS) is filled in during the intervention, consisting of 4 visual analogue scales ranging between 0-100.
Measured: During treatment intervention (total of 5 weeks)
Client satisfaction Questionnaire (treatment satisfaction)
Client Satisfaction Questionnaire (CSQ-8), consisting of 8 questions whereby the answers ranged from totally disagree to totally agree
Measured: After the study intervention and at follow-up
Secondary outcomes (4)
Recruitment/admission ratio (Feasibility)
Recruitment/admission ratio.
Measured: From enrollment to the end of the study at follow-up (total of 18 weeks).
Dropout (Feasibility)
Dropout.
Measured: From enrollment to the end of the study at follow-up (total of 18 weeks).
(serious) adverse events (Feasibility)
(serious) adverse events.
Measured: From enrollment to the end of the study at follow-up (total of 18 weeks).
Variance of effect
Group effects on the Beck Depression Inventory (BDI-II) will be tested at post-treatment and 3 months follow-up (corrected for baseline).
Measured: From enrollment to the end of the study at follow-up (total of 18 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Jun 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Factorial
- Model description
- The design is a randomized, controlled, pragmatic, multicenter, pilot trial. Adult patients with major depressive disorder will be randomized (1:1) to either treatment as usual (TAU) only, or TAU with future-oriented imagery rescripting.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- GGZ Eindhoven (participating site), Mental Care Group (i.e., HSK group and Mentaal Beter; participating sites), Praktijk V (participating site), ZonMw (funding), Depressie Vereniging (patient association), MIND (civil society organization)
- Responsible party
- Principal investigator, Claudi Bockting, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454695
- Sponsor's protocol ID
- 2023.0973
- Other IDs
- NL85551.018.23
- Acronym
- PROFIT
- Status last verified
- Aug 2024
- First submitted
- 23 May 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Very sensitive information.
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Treatment of Severe Major Depressive Disorder by Reducing Negative Future-Oriented Mental Imagery
- ClinicalTrials.gov ID
- NCT06454695
- Acronym / sponsor ID
- PROFIT / 2023.0973
- Keywords
- Imagery rescripting, Prospective negative mental images, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- GGZ Eindhoven (participating site), Mental Care Group (i.e., HSK group and Mentaal Beter; participating sites), Praktijk V (participating site), ZonMw (funding), Depressie Vereniging (patient association), MIND (civil society organization)
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 12 Jun 2024 (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.
Patients with major depressive disorder (MDD) often do not sufficiently benefit from treatment. That is, around 50% of patients with MDD do not respond to treatment and 20-30% only achieve partial remission. Future-oriented negative mental imagery (e.g., mental images of suicide or own funeral) is likely an important maintaining factor of depression and initial studies in depression indicate that targeting mental imagery with 'imagery rescripting' could be a promising therapeutic technique to reduces depressive symptomatology by targeting these images directly that elicits strong affects/emotions and depressive symptomatology.
Before testing the (cost)effectiveness of future-oriented imagery rescripting to treatment as usual (TAU), a pilot study is needed to examine 1) the acceptability of the intervention, 2) the feasibility of the study, and 3) the variance of effect on reducing depressive symptomatology that can serve as estimate of the sample size for a follow-up randomized controlled trial (RCT).
A multicenter pilot RCT with a mixed factorial design with three time points (i.e., baseline, post-treatment, and follow-up of 3 months) will test 50 patients with MDD who will be randomly allocated to future-oriented imagery rescripting plus TAU or TAU only.
The sample consists of adult patients of 18 years or older with an MDD diagnosis.
All patients in this pilot study receive TAU, which involves a combination of pharmacological and psychological interventions. Half of the patients will also receive 3-5 sessions of future-oriented imagery rescripting (ImRes). In each ImRes session, patients identify an image of a autobiographic catastrophic future event (e.g., catastrophic images of future suicide or the loss of work or a loved one). They are subsequently asked to "rescript" this image into a more benign one.
The primary aim of this pilot study is to determine the acceptability of the intervention. The secondary aims are to elucidate factors that may facilitate or hinder the feasibility of the follow-up RCT (e.g., recruitment process) and to estimate the variance of the effect on reduction of depressive symptomatology, which informs the sample size calculation of the follow-up RCT. To study acceptability, the investigators assess depressive symptoms (BDI-II and BADS) and treatment satisfaction (SRS and CSQ-8). To measure feasibility, the investigators will assess recruitment/admission ratio, dropout and (serious) adverse events. Finally, to estimate the variance of effects, group effects on the BDI-II will be tested at post-treatment and follow-up (corrected for baseline).
Imagery rescripting on negative memories has already proven effective and safe in MDD patients. There is no known major risk associated with study participation. Patient burden comprises an online or phone-based screening interview of maximum 60 minutes and several questionnaires. Participants receive a reimbursement of €25,- after study completion (i.e., after follow-up assessment). The project will contribute to improving the care for patients with MDD. If the results show that the intervention is feasible and acceptable, this pilot study will inform the setup of the main RCT on the (cost)effectiveness of the intervention (ZonMW).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The design is a randomized, controlled, pragmatic, multicenter, pilot trial. Adult patients with major depressive disorder will be randomized (1:1) to either treatment as usual (TAU) only, or TAU with future-oriented imagery rescripting.
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | Active comparator | Other: Treatment as UsualParticipants receive Treatment as Usual (TAU) for their depression (i.e., psychotherapy and/or medication). |
| Imagery Rescripting | Experimental | Behavioral: Future-oriented imagery rescripting, Other: Treatment as UsualParticipants receive Treatment as Usual (TAU) for their depression (i.e., psychotherapy and/or medication) plus 3-5 future-oriented imagery rescripting therapy (45 minutes weekly sessions). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years or older;
- Meet DSM-5 criteria for major depressive disorder;
- Presence of 1-3 negative future-oriented mental images, which cause distress;
- Be able to understand questionnaires and study information letter;
- In case of medication use: are stable on medication for six weeks or longer.
Key exclusion criteria (5 listed)
- Current or history of psychotic disorder;
- Current or history of bipolar disorder;
- Severe cognitive impairment (e.g., mental retardation) as evidenced by educational records, parental report and/or clinical impression;
- Current EMDR or imagery rescripting therapy;
- Other circumstances that might affect participation (e.g., severe medical disorder, relocation).
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 |
|---|---|---|
| Future-oriented imagery rescriptingIn this pilot study, in the screening phase, negative or catastrophic future-oriented images will be explored for all patients, including ratings of distress. The future-oriented imagery rescripting consists of 3-5 sessions; each image will be treated in one session, starting with the image that causes highest distress. The protocol is largely based on Hackmann (1998), with minor adaptations from other protocols. | Behavioural | Imagery Rescripting |
| Treatment as UsualPsychotherapy and/or medication | Other | Imagery Rescripting, Treatment as Usual |
Primary outcome
Beck Depression Inventory (Acceptability)
Time frame: From baseline to the end of the study at follow-up (total of 18 weeks).
Beck Depression Inventory (BDI-II) for depressive symptoms, consisting of 21 questions with scores between 0-3 whereby a higher score indicates a worse outcome.
Behavioral Activation for Depression Scale (Acceptability)
Time frame: From baseline to the end of the study at follow-up (total of 18 weeks).
Behavioral Activation for Depression Scale (BADS-NL) for depressive symptoms, consisting of 25 questions with scores between 0-6 whereby a higher score indicates a worse outcome.
Session Rating Scale (Treatment satisfaction)
Time frame: During treatment intervention (total of 5 weeks)
Session Rating Scale (SRS) is filled in during the intervention, consisting of 4 visual analogue scales ranging between 0-100.
Client satisfaction Questionnaire (treatment satisfaction)
Time frame: After the study intervention and at follow-up
Client Satisfaction Questionnaire (CSQ-8), consisting of 8 questions whereby the answers ranged from totally disagree to totally agree
4 secondary outcomes
Recruitment/admission ratio (Feasibility)
Time frame: From enrollment to the end of the study at follow-up (total of 18 weeks).
Dropout (Feasibility)
Time frame: From enrollment to the end of the study at follow-up (total of 18 weeks).
(serious) adverse events (Feasibility)
Time frame: From enrollment to the end of the study at follow-up (total of 18 weeks).
Variance of effect
Time frame: From enrollment to the end of the study at follow-up (total of 18 weeks).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: No. Very sensitive information.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Future-oriented imagery rescripting and Treatment as Usual in people with Major Depressive Disorder and Mental Imagery, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 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 5 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: status not confirmed, as of the sponsor's last update on 23 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evi-Anne van Dis, PhD (+31 630485261, profitstudie@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory (Acceptability) (time frame: From baseline to the end of the study at follow-up (total of 18 weeks).). The study lists 4 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 Aug 2024.