Adolescent Behavior, Cannabis Use, Depression, Suicidal Ideation
Conditions
Brief summary
The goal of this study is to disentangle relationships between acute cannabis use and withdrawal on proximal depression and suicide risk and recovery in adolescents ages 12-18 years by incorporating time-varying patterns of substance use, mood, and SI. This project aims to guide the development of scalable, individualized, accessible, and affordable interventions aimed to reduce depression and suicide risk among adolescents.
Detailed description
We will recruit 200 community-based adolescents, ages 12-18 years, with daily or near daily cannabis use and current depression symptoms. Participants will be enrolled in a 10-week, 3-phased, mixed-methods protocol. All participants will complete a 2 week baseline phase (Phase 1) involving real-time, ambulatory smartphone monitoring (ecological momentary assessment; EMA) during which they will use cannabis per usual to quantify the temporal relationship between use and mood and SI, and the within- (e.g., concurrent other substance use, social context of use) and between-subject factors (e.g., severity of cannabis use, depression and SI) that moderate these linkages. We will work with participants schedule to ensure that the start of this 2-week baseline phase coincides with when they do not anticipate any major deviations from their typical pattern of cannabis use (e.g., family vacation, exam week). After the baseline phase, participants will be scheduled for the randomization component of the study, which will employ a 2-arm, within-subject, parallel group design to examine the effects of short- and longer-term cannabis withdrawal across 8 weeks of cannabis abstinence on depression and SI. Participants will be randomized to 8 weeks of abstinence with contingency management (CB-Abst; n=100) or non-contingent monitoring with no abstinence requirement (CBMon; n=100). Randomization will occur in a 1:1 ratio in blocks of 6 based on a computerized scheme developed by the study statistician. Randomization will be stratified by age, sex, and depression severity. A key aspect of the approach is that the 8-week period is long enough to observe true changes due to cannabis discontinuation, separate from effects of cannabis withdrawal, and residual cannabinoid exposure. Both groups will complete 1-week of EMA in weeks 1 (Phase 2) and 8 (Phase 3) of the randomized study period. In addition to the 3 waves of smartphone, EMA data collection, participants will complete 12 study visits across \ 10 weeks. Visits will entail collection of urine samples for verification of self-reported use and abstinence verification (for CB-Abst during the randomization phase), as well as brief questionnaires and interviews on interim substance use, craving, withdrawal, mood symptoms, and SI.
Interventions
BEHAVIORALContingency management for cannabis abstinence
Those randomized to the abstinence condition (CB-Abst) will be incentivized using an escalating reinforcement schedule for eight weeks of cannabis abstinence.
Sponsors
Massachusetts General Hospital
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Following a shared two-week baseline assessment period (Arm 1) for all enrolled participants, participants will be split into 2 arms, randomly assigned to one of two interventions (Arms 2 or 3, CB-Abst or CB-Mon).
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Ages 12-18; * Current daily or near daily cannabis use (i.e., use ≥ 4 days per week on average; Timeline Followback); * Score ≥ 5 on PHQ-9; * Access to an internet-capable smartphone (iOS or Android); * Provision of at least 1 collateral contact for risk monitoring; * Provision of informed assent (or consent if 18 years or older) and parent/guardian consent if \<age 18; * Greater than 50% response rate to EMA prompts during the first EMA phase; * No immediate plan to discontinue cannabis use in the next 3 months; * Positive toxicology result for cannabis on baseline urinalysis.
Exclusion criteria
* Any factor that impairs ability to comprehend and effectively participate, including acute intoxication at time of consent; * Cannabis use \>4 times/day on average (to maximize likelihood of capturing mood and SI during non-use times); * Inability to speak/write English fluently; * Gross cognitive impairment, for example due to florid psychosis, intellectual disability, developmental delay, or neurodegenerative disease; * Current epilepsy diagnosis; * Individuals who are under the legal protection of the government or state (wards of the state); * Response of "No" to the knowledge check question regarding EMA suicidality response time; * Inability to wear Fitbit device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aim 1: Cannabis use in the last hour | Weeks 1 - 2 (EMA Phase 1; Baseline Use as Usual) | Responses will be collected via ecological momentary assessment based on 7-9 random prompts a day. The outcome is a binary rating as to whether cannabis was used in the last hour, either 0 (No use) or 1 (Use in the last hour). We will examine data from all participants prior to randomization to experimental arms (Pre-intervention Pooled Groups arm). |
| Aim 1: Motivation to use cannabis to improve mood collected | Weeks 1 - 2 (EMA Phase 1; Baseline Use as Usual) | Responses will be collected via ecological momentary assessment based on 7-9 random prompts a day. We will use the subset of responses following cannabis use in the last hour. The outcome is a rating for whether cannabis was used to improve negative mood, from 1 (No, not at all) to 100 (Yes, very much). Higher ratings indicate greater motivation to use cannabis to improve negative mood. We will examine data from all participants prior to randomization to experimental arms (Pre-intervention Pooled Groups arm). |
| Aim 2: Depleted mood | Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence) | Responses will be collected via ecological momentary assessment based on 7-9 random prompts a day. The outcome is a composite score of depleted mood computed as the average over 5 ratings each assessed on a 0 (No, not at all) - 100 (Yes, very much) scale with the following question prompt: Right now how much do you feel \[MOOD\] (sub in Sad/Self-hatred/Numb/Hopeless/Fatigued). Higher ratings indicate worse feelings of depleted mood. We will examine data for participants split between the two experimental arms (CB-Abst versus CB-Mon). |
| Aim 2: Negative cognitive impact | Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence) | Responses will be collected via ecological momentary assessment based on 7-9 random prompts a day. The outcome is a composite score of negative cognitive impact computed as the average over 2 ratings each assessed on a 0 (No, not at all) - 100 (Yes, very much) scale with the following question prompt: Right now how much do you feel \[MOOD\] (sub in Disinterested/Inattentive). Higher ratings indicate worse feelings of negative cognitive impact. We will examine data for participants split between the two experimental arms (CB-Abst versus CB-Mon). |
| Aim 2: Negative activation | Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence) | Responses will be collected via ecological momentary assessment based on 7-9 random prompts a day. The outcome is a composite score of negative activation computed as the average over 3 ratings each assessed on a 0 (No, not at all) - 100 (Yes, very much) scale with the following question prompt: Right now how much do you feel \[MOOD\] (sub in Agitated/Irritated/Anxious). Higher ratings indicate worse feelings of negative activation. We will examine data for participants split between the two experimental arms (CB-Abst versus CB-Mon). |
| Aim 2: Passive suicidal ideation | Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence) | Responses will be collected via ecological momentary assessment based on 7-9 random prompts a day. The outcome is a composite score of passive suicidal ideation computed as the average over 3 ratings each assessed on a 0 (No, not at all) - 100 (Yes, very much) scale with the following question prompt: Right now how strong is your \[IDEATION\] (sub in Thoughts about death/Wishing suffering could be over/Better off as dead). Higher ratings indicate worse passive suicidal ideation. We will examine data for participants split between the two experimental arms (CB-Abst versus CB-Mon). |
| Aim 2: Suicidal urges | Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence) | Responses will be collected via ecological momentary assessment based on 7-9 random prompts a day. The outcome is a rating to the following prompt: right now how strong is your intention to kill yourself, from 0 (No, not at all) to 100 (Yes, very much). Higher ratings indicate worse suicidal urges. We will examine data for participants split between the two experimental arms (CB-Abst versus CB-Mon). |
| Aim 2: Non-suicidal self-injury urges | Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence) | Responses will be collected via ecological momentary assessment based on 7-9 random prompts a day. The outcome is a rating to the following prompt: right now how strong is your desire to hurt your body, from 0 (No, not at all) to 100 (Yes, very much). Higher ratings indicate worse self-injury urges. We will examine data for participants split between the two experimental arms (CB-Abst versus CB-Mon). |
Countries
United States
Contacts
CONTACTRandi M Schuster, PhD
CONTACTJulia Jashinski, MSW
PRINCIPAL_INVESTIGATORRandi M Schuster, PhD
Massachusetts General Hospital
Outcome results
None listed