Improving Prospective Memory Via Telehealth (TPMI)

Trinity Health Of New England

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Educational; Behavioral: Prospective Memory Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05129293

MSH 21-63

Details and patient eligibility

About

Up to 70% of persons with multiple sclerosis (PwMS) experience cognitive impairment, which can have a significant impact on several aspects of their daily lives. One cognitive domain that has been shown to impact daily functioning, but is understudied in MS, is prospective memory (PM). While there have been successful PM interventions in other clinical populations, to date there has not been a specific PM intervention for PwMS that has been tested in a clinical trial.

The study will be a double-masked randomized feasibility trial, with 18 participants randomized to a PM intervention and 18 participants randomized to an active control (psychoeducation). Participants will meet with an interventionist twice a week for four weeks. Feasibility will be assessed via 1) recruitment, enrollment, and retention; 2) adherence to the treatment; 3) treatment credibility and expectancy; and 4) treatment satisfaction. A preliminary effect size (Cohen's d) will be computed for the group difference using participants' performance on the Memory for Intentions Test, which will be given at baseline (week 1) and post-treatment (week 6). Participants will also complete a battery of neuropsychological measures as part of their baseline and post-treatment assessments.

Enrollment: 35 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of MS
• Able to read, write, and speak in English
• Between the ages of 18 and 60
• All genders
• No history of other serious neurologic or psychiatric illness, including drug or alcohol misuse
• No relapses within the past two months
• Access to the Internet and a web camera
• Not enrolled in a cognitive rehabilitation program within the past six months
• Self-reported issues "remembering places they have to be" and "things they have to do"

Exclusion criteria

• No diagnosis of MS
• Unable to complete the study protocol due to language barriers
• Younger than 18 or older than 61
• No gender exclusions
• History of other serious neurologic or psychiatric illness, including drug or alcohol misuse
• Had a relapse within the past two months
• No access to the Internet and/or a web camera
• Currently enrolled or enrolled in a cognitive rehabilitation program within the past six months
• No self-reported issues with "remembering places they have to be" or "things they have to do"

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

35 participants in 2 patient groups

Prospective Memory Intervention

Experimental group

Description:

Participants randomized to the PM intervention (active group) will meet with an interventionist twice a week for four weeks. The first four sessions will focus on visual imagery, while the last four sessions will focus on implementation intentions. Participants will be led through a manualized treatment.

Treatment:

Behavioral: Prospective Memory Intervention

Educational

Active Comparator group

Description:

The control group (Education) will meet with a research assistant for the same frequency of sessions and will receive psychoeducation on MS and cognitive functioning. The interventionists will be following a manual and accompanying PowerPoint slides.

Treatment:

Behavioral: Educational