CCT-A: Compensatory Cognitive Training Via Telehealth for Veterans With Alcohol Use Disorders

Sponsor
Portland VA Medical Center (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT06134128
Collaborator
(none)
30
1
1
20
1.5

Study Details

Study Description

Brief Summary

Most individuals entering treatment for alcohol use disorders (AUDs) present with cognitive deficits across a range of cognitive domains, and these deficits frequently persist for six months or longer following remission. Cognitive deficits are associated with increased relapse rates, less treatment compliance, and poorer treatment outcomes in individuals seeking substance use treatment. Despite the high rates of cognitive impairments among adults with AUDs and their negative impact on treatment outcomes, current evidence-based treatments for AUDs do not specifically treat or address cognitive symptoms. Accessible (e.g., brief, manualized, delivered via telehealth) and effective treatments for adults with AUDs and cognitive deficits are urgently needed.

The primary objective of this study is to assess the feasibility and acceptability of a manualized, 8-week, Compensatory Cognitive Training (CCT) intervention delivered via telehealth for Veterans in early remission from alcohol use disorder (AUD).

The investigators hypothesize that Motivationally Enhanced Compensatory Cognitive Training for Addictions (ME-CCT-A) will be feasible and acceptable in a pilot trial of ME-CCT-A delivered via telehealth.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Motivationally Enhanced Compensatory Cognitive Training for Addictions Group
N/A

Detailed Description

Motivationally Enhanced Compensatory Cognitive Training for Addictions (ME-CCT-A) is a manualized group-based behavioral intervention (8 weeks, 2 hour per week) designed to improve cognitive functioning in Veterans with substance use disorders (SUDs) and cognitive complaints. ME-CCT-A is an adaptation of CCT initially developed by clinicians and researchers at the VA Portland Healthcare System and VA San Diego Healthcare System. CCT draws from the empirical and theoretical literature on compensatory strategy training for conditions characterized by cognitive complaints and impairments, including mild traumatic brain injury, psychosis, and mild cognitive impairment. ME-CCT-A is a comprehensive treatment in that it addresses multiple types of symptoms and concerns that interfere with recovery from addictions - cognitive impairments, neuropsychiatric symptoms, and lifestyle patterns that increase risk of cognitive impairment, poor health, and relapse. In addition to training in compensatory cognitive skills, ME-CCT-A includes mindfulness practices and motivational interviewing techniques to boost the adoption of lifestyle strategies (e.g., nutrition, exercise) that improve cognition and overall health. ME-CCT-A is designed to be easy to administer and as an adjunct to standard SUD treatment programs. While initially designed to be delivered in-person, ME-CCT-A can be delivered through virtual platforms with little to no modification of the content and structure of the intervention.

Given the high rate of AUDs among Veterans, the prevalence of cognitive impairments among those with AUDs, and the negative impact of cognitive impairments on treatment outcomes, an evidence-based cognitive training intervention that optimally addresses the complex needs of Veterans with AUDs and cognitive impairments is of critical importance. This study will allow the investigators to optimize ME-CCT-A for the telehealth format and assess the feasibility and acceptability of the intervention in preparation for a larger-scale pilot randomized control trial.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Compensatory Cognitive Training Via Telehealth for Veterans With Alcohol Use Disorders (CCT-A)
Actual Study Start Date :
Oct 2, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Motivationally Enhanced Compensatory Cognitive Training for Addictions Group

Motivationally Enhanced Compensatory Cognitive Training for Addictions (ME-CCT-A) is a manualized group-based behavioral intervention (8 weeks, 2 hour per week) designed to improve cognitive functioning in Veterans with substance use disorders (SUDs) and cognitive complaints.

Behavioral: Motivationally Enhanced Compensatory Cognitive Training for Addictions Group
8-week manualized group-based behavioral intervention delivered via telehealth

Outcome Measures

Primary Outcome Measures

  1. Recruitment rate [From enrollment to the end of treatment at 8 weeks]

    Number of participants included from eligible Veterans; satisfactory recruitment defined as enrolment of ≥ 50% of eligible Veterans.

  2. Study retention [From enrollment to the end of treatment at 8 weeks]

    Satisfactory retention rate ≥ 75% of participants completing the intervention.

  3. Feasibility of testing procedures [From enrollment to the end of treatment at 8 weeks]

    % of participants where follow-up visit was completed.

  4. Feasibility of data collection methods [From enrollment to the end of treatment at 8 weeks]

    % of participants with complete data sets.

  5. Acceptability, by participant report [Measured after the 8-week intervention]

    Satisfactory acceptability ≥ 70% of participants score ≥ 24 on the CSQ-8.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Male and female Veterans (>18 years) who meet criteria for AUD in early remission (>1 month, <12 months remission) based on the DSM-5 (American Psychiatric Association,
  • Concern about a mild cognitive decline that has been identified by the Veteran or a knowledgeable informant (e.g., SUD treatment providers), and the Veteran wants treatment for their cognitive concerns

  • Access to internet and webcam.

Exclusion Criteria:
  • Intoxication or impaired capacity to understand study risks and benefits

  • Major Neurocognitive Disorder, dementia, neurodegenerative disorder (e.g., Alzheimer's Disease)

  • Auditory or visual impairments that would prevent ability to participate in the cognitive rehabilitation group or benefit from compensatory strategies

Contacts and Locations

Locations

Site City State Country Postal Code
1 Portland VA Medical Center Portland Oregon United States 97239

Sponsors and Collaborators

  • Portland VA Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kate Shirley, Principal Investigator, Portland VA Medical Center
ClinicalTrials.gov Identifier:
NCT06134128
Other Study ID Numbers:
  • 6208
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kate Shirley, Principal Investigator, Portland VA Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2023