Intimate Partner Violence (IPV), Post Traumatic Stress Disorder PTSD
Conditions
Keywords
Psychotherapy, Psilocybin, Acceptance and Commitment Therapy
Brief summary
The goal of this randomized controlled trial is to evaluate the efficacy of psilocybin administered with Acceptance and Commitment Therapy (ACT) as an intervention to reduce post-traumatic stress disorder (PTSD) symptom burden in adult (aged 18-65) survivors of intimate partner violence (IPV). This trail will test the following 2 aims: AIM 1 : To compare the efficacy of a therapeutic psilocybin dose at improving outcomes on the PCL-5 and CAPS-5 as compared to an active control psilocybin dose in IPV survivors with chronic PTSD. AIM 2: To evaluate the efficacy of psilocybin on quality of life, cognitive function, motor ability, depression, anxiety, and cognitive flexibility. Participants will be asked to: * Complete a 2 part screening process * Attend a baseline assessment * Complete a psychoeducation preparation session(s) * Attend psilocybin administration session (receive high dose \[25mg\] or low dose psilocybin \[1mg\]) * Complete 5-6 weekly sessions of ACT * Repeat outcome measures at 1-week, 4 weeks, 3 months (online questionnaires only), and 6 months post-psilocybin administration.
Detailed description
The overall objective of this study is to evaluate the efficacy of psilocybin administered with Acceptance and Commitment Therapy (ACT) as an intervention to reduce post-traumatic stress disorder (PTSD) symptom burden in survivors of intimate partner violence (IPV). This trail will test the following 2 aims: AIM 1 : To compare the efficacy of a therapeutic psilocybin dose (25mg) at improving outcomes on the PCL-5 and CAPS-5 as compared to an active control psilocybin dose (1mg) (allocation ratio 1:1) in IPV survivors with chronic PTSD. Mean baseline scores will be compared to scores at each follow-up timepoint (1-week, 4 weeks, 3 months (PCL-5 only), and 6 months post-psilocybin administration). AIM 2: to evaluate the efficacy of psilocybin on quality of life, cognitive function, motor ability, depression, anxiety, and cognitive flexibility. Mean baseline scores will be compared to scores at each follow-up timepoint (1-week, 4 weeks, 3 months (online only), and 6 months post-psilocybin administration). The secondary efficacy outcomes will include measures of mood, anxiety, post-traumatic stress, cognitive flexibility, emotional regulation, and quality of life. Exploratory Aim: Exploratory objectives of this study include evaluating blood biomarkers reflective of inflammation, growth factors, brain injury, and oxidative stress relevant to PTSD and psilocybin's mechanisms of action. A total of 76 male and female patients between the ages of 18-65 with the last incident of IPV greater than 6 months prior with a score of 1 on the Composite Abuse Scale with repetition of abusive events, meeting DSM-5 criteria for PTSD and a minimum PCL-5 score of 33. All patients will undergo a thorough, 2-part screening procedure. Eligible participants will be randomly allocated 1:1 to either the high dose (38 participants) or low dose (38 participants) psilocybin groups. All participants will be asked to attend a baseline session consisting of clinical and behavioural outcome measures followed by a pre-dosing psychoeducation session. Following the single dosing session, participants will complete 5-6 weekly ACT sessions. Outcome measure assessments will be repeated at 1-week, 4 weeks, 3 months (online only), and 6 months post-dosing.
Interventions
DRUGPsilocybin
See treatment arm description.
Sponsors
University of Calgary
Vancouver Island University
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The group assignments to active (high dose) and control (low dose) psilocybin-assisted therapy will be based on a blocked randomization list (10 participants per block) using sealed envelopes created by an employee of the University of Calgary, who will not be involved in the conduct, or the analysis of the study. The pharmacies administering the psilocybin will be responsible for maintaining the master randomization code list and only the technician preparing the samples will have access to the envelopes and code list. When a new study ID is generated, the technician is to verify the randomization and prepare the participant's study intervention accordingly. Unblinding will only occur once the entire study is completed, and the database has been locked. The trials active intervention and comparator will be provided by the manufactures and will be identical in shape, colour, and weight.
Intervention model description
Double-blinded randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Individuals of all sexes, gender identities, and ethnicities * Ages 19 to 65 years at the time of screening * At least 6 months since last IPV incident * A score of 1 on the Composite Abuse Scale with repetition of abusive events * Minimum PCL-5 score of ≥ 33 * Limited lifetime use of serotonergic hallucinogens * Ability to read/write English
Exclusion criteria
* Severe or moderate substance use disorder other than nicotine in past 6 months * Lifetime diagnosis of schizophrenia or bipolar disorders (or first or second-degree relative) * Active suicidal ideation or serious attempt within the past 1 year. * Current pregnancy or nursing, trying to become pregnant * Any notable abnormality on ECG or routine medical blood laboratory test * Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia * Epilepsy with a history of seizures * Current or recent (within 12 weeks) participation in a clinical trial * Cognitive impairment (SLUMS score \<20) * Suffered a moderate/severe TBI at least once in lifetime * Suffered a mild TBI within the last 6 months * Any other circumstances that, in the opinion of the investigators, compromises participant safety * Not compelled to enter treatment to avoid legal consequences
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | Change from baseline to 1-week, 4 weeks, and 6 months post-dosing | A clinician-administered, 30-item structured interview to diagnose and assess severity of PTSD symptoms in patients. It is widely used and validated, and is considered the gold standard PTSD diagnostic tool. |
| PTSD Checklist for DSM-5 (PCL-5) | Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing | A 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Åsberg Depression Rating Scale, Self-Reported (MADRS-S) | Change from baseline to 1-week, 4 weeks, 3 months, and 6 months post-dosing | A self-reported, 9-item assessment of depressive symptoms using a recall period of the past 7 days. This tool elicits a total score ranging from 0-54, with higher scores indicating greater depression. |
| Generalized Anxiety Disorder-7 (GAD-7) | Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing | A 7-item self-reported questionnaire for measuring the severity of generalized anxiety disorder. Individuals rate how often they have been bothered by seven listed problems and score their responses from 0 ("not at all") to 3 ("nearly every day"). Total scores for anxiety severity are: 0-4: minimal anxiety; 5-9: mild; 10-14: moderate; 15-21: severe anxiety |
| Rivermead Post-Concussion Symptoms Questionnaire (RPQ) | Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing | A self-reported, 16-item questionnaire used to assess severity of 16 commonly experienced PPCS symptoms using a scale of 0 ("not experienced") to 4 ("severe problem"), with higher scores indicating greater PPCS symptom burden. |
| The Acceptance and Action Questionnaire II (AAQ-II) | Change from baseline to 1-week, 4 weeks, and 6 months post-dosing | A 7-item questionnaire measuring psychological flexibility. Scores range from 0 to 49 with higher scores indicating greater psychological flexibility. |
| Cognitive Fusion Questionnaire (CFQ-7) | Change from baseline to 1-week, 4 weeks, and 6 months post-dosing | A 7-point Likert scale measuring cognitive fusion. Scores range from 0 to 49 with higher scores indicating greater fusion with one's thoughts. |
| The World Health Organization Disability Assessment Schedule 2.0 12-item survey (WHODAS) | Change from baseline to 1-week, 4 weeks, and 6 months post-dosing | A 12-item self-administered scale of disability across different diseases, countries, and cultures with higher scores indicating greater disability. |
| 9. EuroQol-5D (EQ-5D-5L) | Change from baseline to 1-week, 4 weeks, and 6 months post-dosing | A self-report measure of 5 key life dimensions, designed to measure health-related quality of life. |
| Cognitive Flexibility Scale (CFS) | Change from baseline to 1-week, 4 weeks, and 6 months post-dosing | A 12-item Likert-scale designed to assess the ability to identify options and alternatives to a situation, flexibility in behaviour, and confidence in the flexible behaviour. |
| The Pittsburgh Sleep Quality Index (PSI) | Change from baseline to 1-week, 4 weeks, and 6 months post-dosing | A 19-item self-reported questionnaire which measures sleep patterns and quality. Items are scored 0 (no difficulty) to 3 (severe difficulty) with higher overall scores indicating poorer sleep quality |
| The Trail-Making Test (TMT) | Change from baseline to 1-week, 4 weeks, and 6 months post-dosing | 2\. The Trail-Making Test (TMT) is a test of general cognitive function, designed to assess working memory, visual processing, visuospatial skills, selective and divided attention, processing speed, and psychomotor coordination. The measure for this 3 to 4-min task is the time required for accurate completion |
| The Digit Span Task (DS) | Change from baseline to 1-week, 4 weeks, and 6 months post-dosing | The Digit Span Task (DS)is a measure of verbal short term and working memory designed to measure simple attention. This 1 to 3-min task required participants to repeat a series of digits increasing in length and is measured through direction of the task, longest sequence successfully complete, and total number of attempts. |
| The Berg's Card Sorting Task (BCST) | Change from baseline to 1-week, 4 weeks, and 6 months post-dosing | The Berg's Card Sorting Task (BCST) is a set-shifting measure of cognitive flexibility modeled after the Wisconsin Card Sorting task.82 Participants must select the stimulus that is different from others based on feedback and adapt their responses once the criteria for correct choice switches. Perseverative errors are defined as the number of instances in which three incorrect responses are made based on a previous rule, and they are thought to reflect less cognitive flexibility (or cognitive rigidity). |
| The Choice Reaction Time (CRT) | Change from baseline to 1-week, 4 weeks, and 6 months post-dosing | The Choice Reaction Time (CRT) Test is a computerized cognitive task that measures attention, processing speed, and motor response by requiring participants to respond quickly and accurately to one of several possible stimuli. Changes in CRT performance may reflect improvements in attention and processing efficiency, key domains often affected by traumatic brain injury. |
Countries
Canada
Contacts
CONTACTChantel T Debert, MD MSc FRCPC
CONTACTChristina Campbell, MSc
PRINCIPAL_INVESTIGATORSandy Shultz, PhD
The Institute on Aging & Lifelong Health, Faculty of Health, University of Victoria
PRINCIPAL_INVESTIGATORLeah Mayo, PhD
Parker Psychedelics Research Chair and Assistant Professor, Department of Psychiatry, University of Calgary, Cumming School of Medicine
PRINCIPAL_INVESTIGATORPamela Kryskow, MD, CCFP
Medical Lead, Psychedelic-assisted Therapy Graduate Program, Vancouver Island University, Medical Director, Roots to Thrive Society
PRINCIPAL_INVESTIGATORZachary Walsh, PhD
Professor, Department of Psychology, University of British Columbia
PRINCIPAL_INVESTIGATORPaul van Donkelaar, PhD
Professor, Faculty of Health and Social Development, School of Health and Exercise Sciences
Outcome results
None listed