Feasibility and Acceptability of a Telehealth Intervention Among Women With Perinatal Mental Health

NCT05832424 | Not Yet Recruiting

• 1 other identifier: bsu0307
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Perinatal Depression; Perinatal Anxiety; Substance Use; Telehealth

Outcome Measures

Primary Outcomes (6)

• Feasibility of Telehealth - Enrollment Number

  The investigators will measure feasibility by the number of participants who agree to participate in the study. The proposed study will provide point estimates and confidence intervals (CIs) for use in a larger, fully powered trial. The recruitment rate will inform population point estimates and 95% CIs for sample measures. For example, with an estimate of 50% recruitment rate (60 assessed), this provides a point of estimate of 50% with a CI of +/- 13%.

  Recruitment

• Feasibility of Telehealth - Number of Sessions Attended

  The investigator will measure feasibility by the number of sessions attended by participants. Attendance will be collected via REDCap to see out of 8 lessons, how many lessons participants attended.

  During 8-weeks intervention

• Feasibility of Telehealth - Drop out rate

  The investigator will measure feasibility by the dropout rate. When the participant decides to drop out, the investigators will mark the participant as "dropped" and calculate drop out rate by the number of participants who "dropped" during the study time divided by the number of participants enrolled.

  Through study completion, an average of 4 months

• Feasibility of Telehealth - Drop out pattern

  The investigator will measure feasibility by the dropout patterns. When the participant decides to drop out, the investigator will ask for the reason and collect the information if the participant chooses to disclose it.

  Through study completion, an average of 4 months

• Acceptability of Telehealth- Satisfaction/Feedback

  The investigator will measure acceptability by utilizing satisfaction/feedback surveys administered at the study exit regardless of whether the individual has completed the intervention. Both ranked, and open-ended responses will assess satisfaction with the intervention overall; satisfaction with the videoconference system and group sessions; and feedback on usability and barriers to participation.

  After completion of the intervention (8-weeks)

• Acceptability of Telehealth- Focus group

  The investigator will measure acceptability by focus group interviews with 6 to 8 other participants, using Zoom. The purpose of the focus group is to collect data directly from participants regarding satisfaction with the program.

  Around 2 months post intervention (focus group)

Secondary Outcomes (3)

• Preliminary data on treatment response- Edinburgh Postnatal Depression Scale (EPDS)

  pre intervention(after the informed consent), post intervention (at the end of intervention average 8 weeks after the intervention starts), 2 months post-intervention

• Preliminary data on treatment response- General Anxiety Disorder (GAD)-7

  pre intervention(after the informed consent), post intervention (at the end of intervention average 8 weeks after the intervention starts), 2 months post-intervention

• Preliminary data on treatment response- National Institute on Drug Abuse (NIDA) Quick Screen/Modified ASSIST

  pre intervention(after the informed consent), post intervention (at the end of intervention average 8 weeks after the intervention starts), 2 months post-intervention

Study Arms (1)

UPLIFT Telehealth Intervention

EXPERIMENTAL

The telehealth group intervention will be delivered using Zoom. Participants will attend facilitated weekly, 1-hour sessions for 8 weeks. The sessions follow a standardized, manualized program based on cognitive-behavioral therapy (CBT) and mindfulness-based practice (MBP)-therapies widely accepted and used by mental health providers for the treatment and prevention of depression and substance use. The study team have tailored this intervention for use in a pregnant population.

Behavioral: UPLIFT program

Interventions

UPLIFT program BEHAVIORAL

The telehealth group intervention will be delivered using Zoom. Participants will attend facilitated weekly, 1-hour sessions for 8 weeks. The sessions follow a standardized, manualized program based on cognitive-behavioral therapy (CBT) and mindfulness-based practice (MBP)-therapies widely accepted and used by mental health providers for the treatment and prevention of depression and substance use. The study team have tailored this intervention for use in a pregnant population.

UPLIFT Telehealth Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boise State University: lead

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: April 27, 2023
• Study Start: March 15, 2024
• Primary Completion: January 22, 2025
• Study Completion: January 22, 2025
• Last Updated: February 14, 2024

Record last verified: 2024-02