Clinical trial NCT05832424: Feasibility and Acceptability of a Telehealth Intervention Among Women With Perinatal Mental Health
Official title: Feasibility and Acceptability of a Telehealth Intervention Among Women With Perinatal Depression/Anxiety and Substance Use Risk.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Perinatal Depression
Perinatal Anxiety
Substance Use
Telehealth
Lead sponsor: Boise State University
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this pilot feasibility/acceptability study is to evaluate the effectiveness of a telehealth approach to increase access to services and reduce depression/anxiety symptoms and risk of substance use in a population of women with perinatal depression/anxiety and elevated substance use risk. The main questions it aims to answer are:

* Assess the acceptability and feasibility of a telehealth approach to deliver an 8-week evidence-based group intervention to women with perinatal depression/anxiety and mild to moderate substance use risk.
* Obtain preliminary data on treatment response to a telehealth 8-week evidence-based group intervention.

Participants will participate in an 8-week evidence-based group intervention and complete the study questionnaire including depression severity, treatment adherence, and substance use risk which will be evaluated at baseline, post-intervention, and 2-month follow-up.

Detailed description: The prevalence of substance use during pregnancy is a population health concern, particularly with the increasing use of opioids and marijuana during pregnancy. At the same time, perinatal depression occurs in 12% to 15% of pregnant and postpartum women. Recent studies indicate that approximately 45% of women with perinatal depression/anxiety report substance use during pregnancy. Likewise, up to 65% of women with perinatal substance use screen positive for symptoms of perinatal depression/anxiety or have a history of depression/anxiety, suggesting that this population is at increased substance-use risk. It is critical to deliver treatment for perinatal mood disorders that also addresses substance-use risk. During the coronavirus disease (COVID-19) pandemic, data suggest a significant relationship between self-reported mental/emotional health, stress, and depressive symptoms and substance use among pregnant women due to intense emotional distress with feelings of uncertainty during the pandemic. Therefore, it is critical to deliver treatment for perinatal mood disorders that also addresses substance-use risk, which refers to current or previous substance use that does not rise to the level of a substance use disorder but does have a known association with progression to a diagnosis of substance use disorder. Effective nonpharmacological approaches (e.g., mindfulness based cognitive-behavioral therapy - MBCT) exist for perinatal depression/anxiety and substance use. However, studies typically evaluate these interventions for perinatal depression/anxiety and substance use separately. Furthermore, perinatal depression rates in rural areas are nearly double, but specialty care for perinatal depression/anxiety and/or substance-use risk are rarely available to childbearing women in rural communities. Although stigma towards perinatal substance use exists in both urban and rural settings, lack of anonymity in rural settings prevent to seek the care of substance use. It is imperative to increase access to mental health services for women in rural areas affected by perinatal depression/anxiety with substance-use risk.

Telehealth is an innovative approach to increase access to therapies such as MBCT for women with perinatal depression/anxiety and for those with increased substance-use risk. Women with perinatal depression/anxiety consider cost and treatment type when seeking care for perinatal depression/anxiety, thus it is important to identify cost-effective preventative care and types of treatment, especially nonpharmacological approaches for this population to increase access of care. The success in using a videoconferencing system to deliver a wide range of care suggests that there is high potential for telehealth to deliver effective and affordable mental health services to women, including in low-resource settings and rural communities. In addition, studies demonstrated the feasibility and acceptability of a group telehealth intervention to deliver MBCT to women experiencing perinatal depressive symptoms. However, there is little evidence indicating that a telehealth approach is acceptable or feasible in a population of women who also have elevated substance-use risk. This study is grounded in a conceptual framework for associations between vulnerability, response, health outcomes, and a technology acceptance model to predict the acceptability of the telehealth approach. A long-term goal of the proposed study is to evaluate the effectiveness of a telehealth approach to increase access to services, improve treatment adherence, and reduce substance use in a population of women with perinatal depression/anxiety and elevated substance use risk. The proposed study will enroll 30 women with known perinatal depression/anxiety symptoms and self-reported substance-use risk into a telehealth intervention group. The specific aims of the study are to:

Aim 1: Assess the acceptability and feasibility of a telehealth approach to deliver an 8-week evidence-based group intervention to women with perinatal depression/anxiety and mild to moderate substance-use risk. Methods: Pregnant and postpartum women (up to 1 year) who screen positive for mild to moderate symptoms of depression (score of 9-20 on the Edinburgh Postnatal Depression Scale - EPDS) and self-reported low to moderate substance use risk (NIDA Quick/Modified ASSIST scores 0-27) will be enrolled in an evidence-based intervention using a telehealth group videoconferencing platform. Women will continue with standard care while attending weekly 1-hour sessions. Feasibility and acceptability will be measured as follows: (1) the number of eligible women who agree to participate in the telehealth intervention, (2) the number of sessions attended, (3) time to and number of participant dropouts, and (4) direct feedback from participants about their experiences with the program (telehealth focus groups and individual surveys).

Aim 2: Obtain preliminary data on treatment response to a telehealth 8-week evidence-based group intervention. Methods: Measures of depression severity, treatment adherence, and substance use risk will be evaluated at baseline, post-intervention, and 2-month follow-up. Measures include the EPDS, General Anxiety Disorder (GAD) -7, and participant reports of substance use risk using a NIDA Quick/Modified ASSIST.

The proposed study will advance the field by establishing whether a telehealth intervention is feasible and acceptable to women with perinatal depression/anxiety and elevated substance-use risk in their communities. Also, this study aligns with programmatic priorities focused on substance abuse and mental health as well as assessing how COVID-19 affects a vulnerable population. Pregnancy can be a motivating time for a woman to seek treatment associated with perinatal depression/anxiety with substance-use risk, but access to effective specialty services is a frequent barrier. Telehealth holds promise for increasing access to mental health services and prevention of increased substance-use risk.

Eligibility criteria: Inclusion Criteria:

* Women 18 and older who, at the time of enrollment
* Have a viable pregnancy or who are up to 12 months postpartum,
* Read and understand English, and
* Have an access to electronic device with internet access.

And who have at least one of the following risk factors for perinatal depression/anxiety:

* Have an Edinburgh Postnatal Depression Scale (EPDS) score of 9-20,
* History of depression or anxiety,
* Have experienced two or more significant life events that put them at risk for developing depression (measured on the screening questionnaire),
* Have an NIDA Quick Screen and answered "yes" with any choices,
* Have a total score of NIDA Modified ASSIST 0-26 (mild to moderate risk) and report the use of common substances (cannabis, prescription opioids, inhalants, prescribed stimulants, and sedatives or sleeping pills) based on NIDA-Modified ASSIST.

Exclusion Criteria:

* Less than 18 years old
* Have an EPDS score \> 20
* Have a NIDA Modified ASSIST score \> 26;
* Have a current diagnosis of a serious mental illness, such as psychosis, schizophrenia, bipolar disorder, severe depression, or suicidality
* Have a current diagnosis of substance use disorder; or
* Currently use street opioids, cocaine, methamphetamine, and/or hallucinogens based on NIDA-Modified ASSIST

Primary outcomes:
measure: Feasibility of Telehealth - Enrollment Number
timeFrame: Recruitment
measure: Feasibility of Telehealth - Number of Sessions Attended
timeFrame: During 8-weeks intervention
measure: Feasibility of Telehealth - Drop out rate
timeFrame: Through study completion, an average of 4 months
measure: Feasibility of Telehealth - Drop out pattern
timeFrame: Through study completion, an average of 4 months
measure: Acceptability of Telehealth- Satisfaction/Feedback
timeFrame: After completion of the intervention (8-weeks)
measure: Acceptability of Telehealth- Focus group
timeFrame: Around 2 months post intervention (focus group)
Secondary outcomes:
measure: Preliminary data on treatment response- Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: pre intervention(after the informed consent), post intervention (at the end of intervention average 8 weeks after the intervention starts), 2 months post-intervention
measure: Preliminary data on treatment response- General Anxiety Disorder (GAD)-7
timeFrame: pre intervention(after the informed consent), post intervention (at the end of intervention average 8 weeks after the intervention starts), 2 months post-intervention
measure: Preliminary data on treatment response- National Institute on Drug Abuse (NIDA) Quick Screen/Modified ASSIST
timeFrame: pre intervention(after the informed consent), post intervention (at the end of intervention average 8 weeks after the intervention starts), 2 months post-intervention
Other outcomes:
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