Cognitive-Behavioral Therapy for Opioid Use Disorder

Overseen By Lisham Ashrafioun, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: No phone, No internet, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

300 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Cognitive-Behavioral Therapy for Opioid Use Disorder?

Research shows that cognitive-behavioral therapy (CBT) can effectively help cancer patients manage emotional distress, suggesting it may also be beneficial for those with opioid use disorder. Group CBT has been shown to help emotionally distressed individuals, indicating its potential to support people dealing with social isolation and loneliness. ^{1 2 3 4 5}

Is Cognitive-Behavioral Therapy (CBT) safe for humans?

Cognitive-Behavioral Therapy (CBT) is generally considered safe for humans and is widely used to treat various mental health conditions, including anxiety and depression, without significant safety concerns. ^{6 7 8 9 10}

How is the treatment Cognitive-Behavioral Therapy for Perceived Social Isolation different from other treatments for opioid use disorder?

This treatment is unique because it combines cognitive-behavioral therapy (CBT) with a focus on reducing loneliness and social isolation, which are factors linked to higher opioid use. By addressing these social aspects, it aims to improve engagement and retention in treatment, which are common challenges in opioid use disorder care. ^{11 12 13 14 15}

What is the purpose of this trial?

This study aims to enroll 300 participants who will be assigned to one of three 3 groups. Each group will receive an intervention lasting 6, weekly sessions of 40-60 minutes. Eligibility include having an opioid use disorder and reporting loneliness or feeling alone or disconnected.

Eligibility Criteria

This trial is for adults over 18 who understand English, have internet access, and are experiencing both opioid use disorder and feelings of loneliness or disconnection.

Inclusion Criteria

I understand English and have internet access.

I feel very lonely often.

I have been diagnosed with an opioid addiction.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three interventions: therapist-delivered cognitive-behavioral therapy, therapist-delivered health education, or self-guided health education over 6 weekly sessions

6 weeks

6 visits (virtual for therapist-delivered sessions)

Follow-up

Participants are monitored for changes in loneliness, opioid use, social interactions, and mental health factors

6 months

Assessments at 1, 3, and 6 months post-treatment

Treatment Details

Interventions

• Cognitive-Behavioral Therapy for Perceived Social Isolation
• Health Education

Trial Overview The study tests Cognitive-Behavioral Therapy aimed at reducing perceived social isolation versus Health Education. Participants will be divided into three groups receiving weekly sessions for six weeks.

Participant Groups

Group I: Cognitive-Behavioral Therapy Experimental Treatment 1 Intervention

CBT delivered over the course of 6, \~45 minute sessions delivered via telehealth

Group II: self-guided Health Education Active Control 1 Intervention

Health education sessions that are self-guided over the course of 6 sessions

Group III: therapist-delivered Health Education Active Control 1 Intervention

Health education sessions delivered over the course of 6, \~45 minute sessions delivered via telehealth.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Findings from Research

Group cognitive behavioural therapy (CBT) has been shown to effectively address significant and long-term psychosocial problems in cancer patients, including those with advanced disease.

The article emphasizes the importance of time-limited interventions and provides guidance for health workers on how to implement group CBT techniques to support emotionally distressed cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group cognitive behavioural therapy: an intervention for cancer patients. Bottomley, A.[2019]

A systematic review of 35 studies, including 30 randomized controlled trials, found that internet-based support interventions can positively impact the quality of life and physical health of breast cancer patients.

However, the effectiveness of these interventions in reducing psychological distress, anxiety, and depression was inconsistent, highlighting the need for more rigorous research to better understand their overall impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of internet-based support interventions on patients with breast cancer: a systematic review and narrative synthesis. Huang, Y., Li, Q., Zhou, F., et al.[2022]

Patients with cancer are living longer, highlighting the need for diverse psychosocial interventions to support their mental and emotional well-being.

The review identifies four common types of interventions—education, behavioral training, individual psychotherapy, and group interventions—each offering potential psychological and physical health benefits for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical review of psychosocial interventions in cancer care. Fawzy, FI., Fawzy, NW., Arndt, LA., et al.[2022]

A new conceptual framework was developed to help psychosocial care providers implement evidence-based psychological treatments (EBTs) for cancer patients, based on qualitative data from 125 trainees across two phases of training and support.

The framework emphasizes the importance of both personal factors (like attitudes and behaviors) and environmental factors (such as resources and organizational support) in overcoming implementation challenges, suggesting that improving personal support can help address resource limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing evidence-based psychological treatments for cancer patients. Williams, KC., Brothers, BM., Ryba, MM., et al.[2022]

Psychological issues are common among cancer patients, and while adjuvant psychological therapy (APT) is recognized, there is limited research on the effectiveness of cognitive behavior therapy (CBT) specifically for this group.

CBT can be adapted for cancer patients, addressing unique emotional responses and vulnerabilities, and may help in preventing relapse of psychological issues, highlighting the need for tailored therapeutic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer, emotional responses and cognitive behavioural psychotherapy. Farrington, A.[2019]

Both Resource-oriented cognitive-behavioral therapy (ROCBT) and cognitive therapy (CT) are effective treatments for social anxiety disorder, with treatment gains maintained over a 2-year follow-up period involving 51 patients.

At the 10-year follow-up with 27 patients, significant improvements were observed in social anxiety measures, indicating that both therapies provide durable benefits over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychotherapy for social anxiety disorder: long-term effectiveness of resource-oriented cognitive-behavioral therapy and cognitive therapy in social anxiety disorder. Willutzki, U., Teismann, T., Schulte, D.[2018]

A tailored internet-delivered cognitive behavioral therapy (ICBT) program for Canadian public safety personnel (N=83) resulted in large reductions in depression and anxiety symptoms, and moderate reductions in PTSD symptoms after 8 weeks of treatment.

Most participants who initially reported high levels of depression, anxiety, and PTSD experienced clinically significant symptom improvements, indicating that ICBT is a promising treatment option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Outcomes of Transdiagnostic Internet-Delivered Cognitive Behavioral Therapy Tailored to Public Safety Personnel: Longitudinal Observational Study. Hadjistavropoulos, HD., McCall, HC., Thiessen, DL., et al.[2021]

A manualized cognitive-behavioral therapy (CBT) treatment for social anxiety disorder (SAD) was implemented in a case study of a 26-year-old male, resulting in complete remission of his symptoms after 15 sessions.

Follow-up assessments at 2 and 8 months post-treatment showed that the remission of SAD symptoms was maintained, highlighting the long-term efficacy of this CBT approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manualized Cognitive-Behavioral Treatment of Social Anxiety Disorder: A Case Study. Shorey, RC., Stuart, GL.[2021]

A study of 121 mental health care professionals in Saudi Arabia revealed a significant lack of knowledge about computerized cognitive behavioral therapy (cCBT), despite a positive attitude towards its use in therapy.

Most participants believed in the efficacy of cCBT and felt comfortable using computers, indicating a readiness for further education and training in this area to improve mental health treatment accessibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perception of Mental Health Care Professionals in Saudi Arabia on Computerized Cognitive Behavioral Therapy: Observational Cross-sectional Study. AlHadi, AN., Alammari, KA., Alsiwat, LJ., et al.[2021]

Cognitive-behavioral therapy (CBT) is based on scientific experimentation rather than just theories, making it a unique and evidence-based approach to treatment.

Recent research at the University of Minnesota has integrated new neuroscientific findings with CBT, potentially enhancing its effectiveness and understanding in therapeutic practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of cognitive-behavioral therapy in the University of Minnesota's outpatient psychiatry clinic. Kushner, MG.[2018]

Mental health professionals believe that key components of cognitive-behavioral therapy (CBT) for treating opioid use disorder (OUD) include building a strong treatment alliance, teaching coping skills, and using motivational interviewing, which were rated as the most effective strategies.

To enhance the effectiveness of CBT for OUD, professionals suggested incorporating mindfulness practices, peer support, and strategies for medication adherence, while also emphasizing the importance of addressing co-occurring mental health issues and life stressors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mental health professional survey of cognitive-behavioral therapy for the treatment of opioid use disorder. Lent, MR., Callahan, HR., Womer, P., et al.[2021]

The study involved interviews with 14 individuals undergoing intensive outpatient treatment (IOT) for opioid use disorder (OUD), revealing that the process of connecting and disconnecting is crucial to their recovery experience.

Participants emphasized the importance of building connections with the IOT program, fellow patients, and staff, suggesting that fostering these relationships can significantly enhance engagement and support successful recovery from OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Connecting and disconnecting: Experiences of people with opioid use disorder in intensive outpatient treatment. Keen, A., Lu, Y., Draucker, CB.[2022]

A study involving 31 participants with experience in opioid use disorder treatment found that a mobile app designed for telehealth delivery of treatment was rated highly for usability, with participants appreciating its flexibility and helpful features.

Participants not only found the current app features useful but also expressed enthusiasm for proposed additions like daily affirmations and medication reminders, indicating that such technology could help overcome barriers to treatment and support long-term recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient evaluation of a smartphone application for telehealth care of opioid use disorder. Bosse, JD., Hoffman, K., Wiest, K., et al.[2022]

In a study of 371 adults receiving methadone maintenance treatment for opioid use disorder, severe loneliness was found to significantly increase the likelihood of illicit opioid use among women, with an odds ratio of 3.00, while it decreased the likelihood among men, with an odds ratio of 0.35.

The findings suggest that addressing loneliness in treatment plans could improve recovery outcomes for patients with opioid use disorder, highlighting the need for strategies that foster social connections in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Loneliness and Illicit Opioid Use Among Methadone Maintenance Treatment Patients. Polenick, CA., Cotton, BP., Bryson, WC., et al.[2020]

In a study of 82 patients undergoing treatment for opioid use disorder with buprenorphine, 40.3% tested positive for non-prescribed opioids, indicating a significant issue of illicit opioid use among this population.

Higher levels of loneliness were linked to an increased likelihood of using non-prescribed opioids, suggesting that loneliness may be a risk factor for treatment failure in patients with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association of Loneliness and Non-prescribed Opioid Use in Patients With Opioid Use Disorder. McDonagh, J., Williams, CB., Oldfield, BJ., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Group cognitive behavioural therapy: an intervention for cancer patients. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of internet-based support interventions on patients with breast cancer: a systematic review and narrative synthesis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Critical review of psychosocial interventions in cancer care. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Implementing evidence-based psychological treatments for cancer patients. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Cancer, emotional responses and cognitive behavioural psychotherapy. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Psychotherapy for social anxiety disorder: long-term effectiveness of resource-oriented cognitive-behavioral therapy and cognitive therapy in social anxiety disorder. [2018]

7. Canada pubmed.ncbi.nlm.nih.gov

Initial Outcomes of Transdiagnostic Internet-Delivered Cognitive Behavioral Therapy Tailored to Public Safety Personnel: Longitudinal Observational Study. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Manualized Cognitive-Behavioral Treatment of Social Anxiety Disorder: A Case Study. [2021]

9. Canada pubmed.ncbi.nlm.nih.gov

Perception of Mental Health Care Professionals in Saudi Arabia on Computerized Cognitive Behavioral Therapy: Observational Cross-sectional Study. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

The use of cognitive-behavioral therapy in the University of Minnesota's outpatient psychiatry clinic. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

A mental health professional survey of cognitive-behavioral therapy for the treatment of opioid use disorder. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Connecting and disconnecting: Experiences of people with opioid use disorder in intensive outpatient treatment. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Patient evaluation of a smartphone application for telehealth care of opioid use disorder. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Loneliness and Illicit Opioid Use Among Methadone Maintenance Treatment Patients. [2020]

15. Netherlands pubmed.ncbi.nlm.nih.gov

The Association of Loneliness and Non-prescribed Opioid Use in Patients With Opioid Use Disorder. [2021]