- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04342416
Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
Using a Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Reykjavík, Iceland, 101
- University of Iceland
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Having experienced at least one criterion A trauma according to the DSM-5
- Having at least one intrusive memory that occurs at least three times per week in the past four weeks
- Being able to attend 3-8 sessions with researcher
- Being willing to monitor intrusive memories in daily life
- Having access to a smartphone
- Being able to speak Icelandic and read study materials in Icelandic
Exclusion Criteria:
- Current psychotic disorder (determined by the psychotic module on the Mini International Neuropsychiatric Interview (MINI)).
- Current manic episode (determined by the bipolar module on the Mini International Neuropsychiatric Interview (MINI)).
- Being acutely suicidal (according to the module assessing suicidality on the Mini International Neuropsychiatric Interview (MINI)).
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: Trauma exposed women
No Intervention: Baseline phase ('A'): Measurements collected in a daily diary four times a day (morning, afternoon, evening and night) over one week for the primary outcome (occurrence of intrusive memories of trauma). Individual baseline phases will be used as control periods. Experimental: Intervention phase ('B'): A one-session intervention with a researcher including a simple cognitive task (a memory cue and 25 minutes of Tetris game-play with mental rotation) followed by instructions to engage in the task self-guided over the subsequent week. Measurements collected in a daily diary four times a day following the intervention for the primary outcome (occurrence of intrusive memories of trauma). Intervention: Behavioral: Brief cognitive intervention |
Behavioral: Brief cognitive intervention.
A one-session intervention with a researcher including a simple cognitive task (a memory cue and 25 minutes of Tetris game play with mental rotation) with instructions to engage in the task self-guided in the subsequent weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the number of intrusive memories of trauma
Time Frame: Baseline week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
|
Number of intrusive memories of traumatic event recorded by participants in a diary daily (morning, afternoon, evening and night) for one week during the baseline phase and each week during the intervention phase (week 1-6) and during one week at one month follow-up and three month follow-up.
|
Baseline week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-guided intervention adherence - usage of the gameplay intervention in daily life
Time Frame: Intervention week 2-6
|
How often did you manage to play Tetris after you experienced an intrusive memory?
(11-point scale; 0 = not at all; 10 = every time).
|
Intervention week 2-6
|
Feasibility and acceptability ratings for using a smartphone game-play intervention
Time Frame: Post intervention up to week 7
|
Feasibility and Acceptability of the intervention assessed with two self-rated items, "Would you recommend playing Tetris to a friend?" and "Do you consider gameplay to be an acceptable way to reduce the daily frequency of intrusive memories?".
Scores could range from 0 - 10 with higher scores indicating greater acceptability/feasibility.
|
Post intervention up to week 7
|
Feasibility and acceptability - open ended questions
Time Frame: Post intervention up to week 7
|
Two open-ended questions: 1. "How did you feel about playing Tetris after you had an intrusive memory?" 2. "Did you find the intervention helpful?
If yes, how?"
|
Post intervention up to week 7
|
Impact of intrusive memories on concentration, sleep and stress - ratings
Time Frame: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
|
Six self-rated items to assess the impact of intrusive memories on concentration, sleep, and stress in the past week.
2 items assessing concentration difficulties in general and due to intrusive memories (11-point scale; high scores indicating more difficulties).
2 items assessing sleep disturbances due to intrusive memories (11-point scale; higher scores indicating more sleep disturbance); and 1 item assessing to what degree intrusive memories affected stress levels (0 = not at all; 10 = affected very much).
|
Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
|
Rating of how long intrusive memories disrupted concentration on average
Time Frame: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
|
1 item assessing for how long intrusive memories disrupted concentration on average on a 6-point scale (0 = <1 minute - 6 = > 60 minutes)
|
Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
|
General impact of intrusive memories - ratings
Time Frame: Baseline week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
|
Two items both rated on an 11-point scale: 1. "During the last week, how distressing were your intrusive memories (0 = not at all; 10 = very distressing).
2. During the last week, how vivid were your intrusive memories (0 = not at all; 10= very vivid)
|
Baseline week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
|
Intrusion diary adherence
Time Frame: Baseline phase week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
|
Adherence to the intrusion diary assessed with 1 item: "How accurately did you fill out the diary?" (0= not at all; 10 = very accurately)
|
Baseline phase week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
|
The Posttraumatic Stress Disorder Checklist 5 (PCL-5)
Time Frame: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
|
The PCL-5 is a short 20-item self-report scale used to assess the severity of PTSD symptoms corresponding to the DSM-5 criteria for PTSD.
Symptoms are rated from 0-4.
Higher scores indicate greater severity.
|
Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
|
The Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
|
The PHQ-9 is a 9-item self-report measure of depression symptoms and the severity of those symptoms.
Each item can be scored from 0 (i.e., not at all) to 3 (i.e., nearly every day).
|
Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
|
The Generalized Anxiety Disorder-7 scale (GAD-7)
Time Frame: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
|
The GAD-7 is a brief self-report questionnaire designed as a screening tool for symptoms of general anxiety disorder and their severity.
Each item can be scored from 0 (i.e., not at all) to 3 (i.e., nearly every day).
|
Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
|
The Sheehan Disability Scale (SDS)
Time Frame: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
|
The SDS is a self-report questionnaire which is designed to assess functional impairment across three domains: (1) Work/school, (2) social, and (3) family life.
These domains are measured on an 11-point scale which ranges from 0 (i.e., not at all) to 10 (i.e., extremely).
The scale will be adjusted to assess impairment associated with intrusive memories.
|
Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
|
Impact of intrusive memories on functioning
Time Frame: Baseline week 1; Post intervention up to week 7, 1 month follow-up and 3 month follow-up
|
Two questions assessing the impact intrusive memories have on functioning in daily life.
One question is open-ended: "Have the intrusive memories affected your ability to function in your daily life in the past week?
If yes, how?" and one question is self-rated: "Have the intrusive memories affected your ability to function in your daily life?" (11-point scale, higher score indicate greater impact on functioning.)
|
Baseline week 1; Post intervention up to week 7, 1 month follow-up and 3 month follow-up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- VIRMT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Trauma
-
Humacyte, Inc.Active, not recruitingTrauma | Trauma Injury | Trauma, Multiple | Trauma BluntUkraine
-
Wonju Severance Christian HospitalNational Research Foundation of KoreaRecruitingTrauma Injury | Trauma, MultipleKorea, Republic of
-
Prof. Dr. Cemil Tascıoglu Education and Research...CompletedTrauma Injury | Trauma, MultipleTurkey
-
University Hospital, AngersRecruiting
-
Rabin Medical CenterIsraeli Ministry of SecurityUnknown
-
Oslo University HospitalUniversity of Oslo; Sunnaas Rehabilitation Hospital; South-Eastern Norway Regional...RecruitingTrauma Injury | Trauma, Multiple | PolytraumaNorway
-
Chang, Steve S., M.D.Santa Barbara Cottage Hospital; Accumetrics, Inc.CompletedHead Injury Trauma BluntUnited States
-
Assistance Publique - Hôpitaux de ParisFrancophone Pediatric Resuscitation and Emergency Group (GFRUP)Completed
-
Norwegian University of Science and TechnologySt. Olavs HospitalTerminatedTrauma, Multiple | Trauma Severity Indices | Injuries, Multiple | Norway/Epidemiology | Trauma Centers/Statistics & Numerical Data
-
University Hospital, ToulouseNot yet recruiting
Clinical Trials on Visiospatial Interference
-
Université Catholique de LouvainCentre Hospitalier Universitaire Vaudois; Cliniques universitaires Saint-Luc-... and other collaboratorsUnknownCraving | Gambling | Gambling Disorder | Gambling, Pathological | Gambling ProblemSwitzerland
-
University of IcelandCompleted
-
Kessler FoundationCompleted
-
Medical University of South CarolinaCompletedHealthy VolunteersUnited States
-
Central South UniversityRejoin Hangzhou Martins Medical Equipment Co., Ltd.UnknownPEEK Interference Screw; Fixation; Anterior Cruciate Ligament ReconstructionChina
-
Ramathibodi HospitalThammasat UniversityCompleted
-
Paragon 28CompletedAnkle Injuries | Achilles Tendon Rupture | Ankle Sprains | Syndesmotic Injuries | Ankle Inversion Sprain | Flexor Digitorum Longus on the Right | Flexor Digitorum Longus on the Left | Deltoid Ankle Sprain | Flexor Hallucis Longus on the Left | Flexor Hallucis Longus on the RightUnited States
-
Drexel UniversityPennsylvania Department of HealthCompletedHealthy Individuals | LearningUnited States
-
Beth Israel Deaconess Medical CenterBoston UniversityActive, not recruiting
-
Unity Health TorontoCharite University, Berlin, Germany; Centre for Addiction and Mental Health; Beth... and other collaboratorsNot yet recruitingMajor Depressive Disorder