Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454695
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-23
Brief Title:
Improving Treatment of Major Depressive Disorder by Reducing Negative Future-Oriented Mental Imagery
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Improving Treatment of Severe Major Depressive Disorder by Reducing Negative Future-Oriented Mental Imagery
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROFIT
Brief 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 Future-oriented negative mental imagery eg 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 affectsemotions and depressive symptomatology
Before testing the costeffectiveness 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 ie 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 eg 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 eg 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 recruitmentadmission 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 ie 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 costeffectiveness of the intervention ZonMW
Before testing the costeffectiveness 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 ie 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 eg 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 eg 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 recruitmentadmission 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 ie 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 costeffectiveness of the intervention ZonMW
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL8555101823 | OTHER | ToetsingOnline | None |