Motivational Interviewing for Anhedonia

(SAMI Trial)

Recruiting at 1 trial location

Overseen By Junghee Lee, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must be taking: 2nd generation antipsychotics

Must not be taking: Sedatives, Anxiolytics

Disqualifiers: Substance use disorder, Epilepsy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 3 weeks

152 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how motivational interviewing (also known as Motivational Interviewing Therapy, or MI) can enhance the ability to enjoy social interactions for individuals who have experienced their first episode of psychosis. Participants will either receive motivational interviewing or join a control group focused on nutrition education. The main goal is to determine if motivational interviewing can increase enjoyment in social settings, both in behavior and brain activity. Ideal candidates are those who have had their first psychosis episode within the last three years and are already on certain antipsychotic medications. As an unphased trial, this study offers a unique opportunity to contribute to understanding how motivational interviewing can enhance social enjoyment for those with early psychosis.

Do I have to stop taking my current medications?

The trial requires that you stay on your current 2nd generation antipsychotic medications. You cannot change medications 3 weeks before enrolling. However, you cannot take sedatives or anxiolytics on the day of assessment.

What prior data suggests that motivational interviewing is safe for individuals with first-episode psychosis?

Research has shown that Motivational Interviewing is generally safe for participants. This counseling method helps people make positive behavioral changes and is often used in settings like alcohol use therapy and mental health support. Studies have found that people usually tolerate it well, with no major reports of harmful side effects. This suggests that the treatment is likely safe for those participating in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about motivational interviewing for anhedonia because it offers a fresh approach compared to traditional treatments like antidepressants and cognitive-behavioral therapy. While most treatments for anhedonia focus on chemical imbalances or behavioral changes, motivational interviewing aims to enhance sensitivity to social rewards through targeted conversations. This method could potentially boost motivation and engagement in social activities, which are often difficult for those experiencing anhedonia. Additionally, since it involves just a few short sessions, it might provide quicker relief compared to the longer time frames needed for medications or extensive therapy.

What evidence suggests that motivational interviewing is effective for social anhedonia?

Research has shown that Motivational Interviewing (MI), which participants in this trial may receive, can assist individuals experiencing anhedonia, a condition where feeling pleasure is difficult. In past studies, MI helped people with depression, often marked by symptoms like anhedonia, engage more effectively with their treatment. MI boosts motivation and reduces doubt, facilitating behavior change. It has also successfully supported adherence to treatments for other issues, such as alcohol abuse. These findings suggest that MI might enhance responses to social interactions, particularly for those who have experienced their first episode of psychosis. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-35 who have had their first psychotic episode within the last two years and are diagnosed with schizophrenia, schizophreniform, or schizoaffective disorder. They must be on second-generation antipsychotics, have an IQ over 70, speak English fluently, and have good vision with correction. Participants should not have a history of substance abuse or significant medical conditions.

Inclusion Criteria

Sufficient fluency in English to comprehend testing procedures

I am currently taking second-generation antipsychotic medications.

Your estimated IQ before getting sick is at least 70 based on a specific test.

Exclusion Criteria

I am not currently pregnant.

I haven't taken any sedatives or anxiety medication today.

No medication change 3 weeks prior to enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo three 45-minute sessions of either motivational interviewing or didactic training on nutrition

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in social reward sensitivity and neural activation

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Motivational Interviewing

Trial Overview The study tests if motivational interviewing can affect how people with social anhedonia experience social rewards. Half will receive motivational interviewing; the other half will get nutrition training as a control. Both groups perform tasks in a scanner before and after to see changes at behavioral and neural levels.

How Is the Trial Designed?

Group I: Motivational Interview Intervention Experimental Treatment 1 Intervention

This arm involves three 45-minute sessions on motivational interviewing targeting sensitivity to social reward.

Group II: Active Control Intervention Active Control 1 Intervention

This arm involves three 45-minute sessions on didactic training on nutrition.

Motivational Interviewing is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Motivational Interviewing for:

• Substance Use Disorders
• Mental Health Conditions

Approved in European Union as Motivational Interviewing for:

• Addiction Treatment
• Behavioral Health Interventions

Approved in Canada as Motivational Interviewing for:

• Substance Abuse Treatment
• Mental Health Counseling

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Anhedonia, a key symptom in depression and mood disorders, highlights the urgent need for effective treatments, as it significantly impacts patients' quality of life.

Recent research is exploring new pharmacological targets for treating anhedonia, including the kappa-opioid receptor and KCNQ2/3 receptors, along with the promising anti-anhedonic effects of ketamine and psychedelic agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological Treatments for Anhedonia. Klein, ME., Grice, AB., Sheth, S., et al.[2022]

A case study of a patient with major depression showed that a computerized cognitive training program focused on generating positive mental imagery can enhance positive feelings and expectations in daily life.

The intervention may help reduce symptoms of anhedonia (the inability to feel pleasure) by promoting involuntary positive imagery in relevant situations, suggesting it could be a valuable tool in improving depression treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brightening the Day With Flashes of Positive Mental Imagery: A Case Study of an Individual With Depression. Blackwell, SE., Holmes, EA.[2022]

The study aims to assess the feasibility of adding a positive mental imagery training (PMIT) module to standard inpatient mental health treatment, with a focus on increasing positive affect and reducing anhedonia in up to 90 patients over a 2-week period.

By comparing PMIT with cognitive control training and standard treatment alone, the research will provide insights into the potential effectiveness of PMIT as an adjunct therapy, which could lead to improved recovery outcomes in mental health settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized positive mental imagery training versus cognitive control training versus treatment as usual in inpatient mental health settings: study protocol for a randomized controlled feasibility trial. Blackwell, SE., Westermann, K., Woud, ML., et al.[2022]

A personalized lifestyle advice intervention for young adults with anhedonia showed that changes in how individuals react to negative events may be a key mechanism for improving their positive affect (PA).

The study involved 69 participants and used the Experience Sampling Method to assess changes in pleasure and affect before and after the intervention, but did not find significant changes in reactivity to positive events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized lifestyle advice alters affective reactivity to negative events in anhedonic young adults. Schmitter, M., van Roekel, E., Heininga, VE., et al.[2021]

In a study of 683 participants, physical and social anhedonia were found to be most prevalent in patients with major depressive disorder (MDD), and these patients exhibited higher rates of recent suicidal ideation and lifetime suicide attempts.

No significant link was found between anhedonia and suicidality in patients with schizophrenia, suggesting that different risk factors may contribute to suicidality in this group compared to those with MDD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical and social anhedonia are associated with suicidality in major depression, but not in schizophrenia. Sagud, M., Tudor, L., Šimunić, L., et al.[2021]

This meta-analysis of 20 studies involving 11,212 individuals found a significant moderate correlation (r = 0.31) between anhedonia and suicidality, indicating that higher levels of anhedonia are associated with increased risk of suicidal thoughts and behaviors.

Specifically, anticipatory and consummatory interpersonal anhedonia showed an even stronger correlation (r = 0.40), suggesting that these dimensions of anhedonia may be critical risk factors for suicidality and should be considered in future risk assessments and prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Anhedonia as a risk factor in suicidality: A meta-analysis. Gillissie, ES., Le, GH., Rhee, TG., et al.[2023]

The paper identifies three distinct clinical presentations of anhedonia in treatment-resistant depression (TRD): congenital, stress-induced, and medication-exacerbated, highlighting the complexity of this symptom.

By understanding these patterns, the authors advocate for further research to validate the mechanisms behind anhedonia, which could lead to more personalized and effective treatment strategies for TRD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment-resistant depression with anhedonia: Integrating clinical and preclinical approaches to investigate distinct phenotypes. Kelly, CA., Freeman, KB., Schumacher, JA.[2022]

Motivational Interviewing (MI) has proven effective in helping patients with substance use and psychiatric disorders, particularly when their ambivalence hinders progress in therapy.

The success of MI relies heavily on the caregiver's communication skills, especially in fostering 'change talk' from patients, suggesting that training in MI techniques should be included in psychiatric education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Motivational interviewing in psychiatry]. Mechtcheriakov, S., Rettenbacher, M.[2021]

Motivational interviewing (MI) has expanded beyond its initial focus on addictions and health-related behaviors, now being applied to a variety of clinical issues such as anxiety, depression, and intimate partner violence.

The article series includes case reports demonstrating the effectiveness of MI in addressing diverse problems, highlighting its versatility and potential benefits in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introduction to the special series on motivational interviewing and psychotherapy. Arkowitz, H., Westra, HA.[2009]

Motivational interviewing (MI) is an effective technique for helping patients recognize the need for change in their habits, such as alcohol dependence, by moving them from complacency to a desire for improvement.

The collaborative nature of MI involves using tools like the decisional balance sheet to help patients weigh the pros and cons of their habits, facilitating a personalized approach to treatment based on their readiness for change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Psychiatrist's Guide to Motivational Interviewing. Griffith, LJ.[2021]

Staff in Swedish prisons who received ongoing training in motivational interviewing (MI) showed significantly greater competency in MI skills compared to those conducting usual prison planning interviews, indicating that continuous training is beneficial.

However, overall competency levels among staff were low, suggesting that even with training, more extensive and ongoing support is necessary to achieve proficiency in MI techniques for effectively helping substance-misusing prisoners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning motivational interviewing in a real-life setting: a randomised controlled trial in the Swedish Prison Service. Forsberg, L., Ernst, D., Farbring, CÅ.[2022]

Anhedonia, a symptom of depression characterized by a lack of interest or pleasure, can significantly hinder treatment engagement, leading to poorer outcomes for individuals with depression.

The review suggests that targeted interventions addressing specific deficits in reward functioning can enhance treatment initiation and continuation for those with heightened anhedonia, and these interventions can be integrated into existing mental health referral and treatment processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing anhedonia to increase depression treatment engagement. Khazanov, GK., Forbes, CN., Dunn, BD., et al.[2022]

Motivational interviewing (MI) significantly reduces substance use compared to no treatment, with the strongest effect observed immediately after the intervention (SMD 0.79), but the effect diminishes over time, becoming non-significant in long-term follow-ups.

MI shows no significant advantage over standard treatment methods, but it outperforms assessment and feedback interventions in medium-term follow-ups (SMD 0.38), indicating its potential value in specific contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing for substance abuse. Smedslund, G., Berg, RC., Hammerstrøm, KT., et al.[2022]

Cognitive Behavioural Therapy (CBT) and Behavioural Activation (BA) both significantly improved anhedonia in patients with major depressive disorder during a six-month treatment period, but neither treatment fully restored pleasure levels to those of healthy individuals.

Despite improvements in anhedonia, both therapies showed only partial effectiveness, indicating a need for further refinement of these treatments or the development of new therapies specifically targeting anhedonia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How well do Cognitive Behavioural Therapy and Behavioural Activation for depression repair anhedonia? A secondary analysis of the COBRA randomized controlled trial. Alsayednasser, B., Widnall, E., O'Mahen, H., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-anhedonia-2023-40ca0

Motivational Interviewing for Anhedonia (SAMI Trial) The available research shows that Motivational Interviewing for Anhedonia can help improve treatment engagement for people with depression. Anhedonia, which is ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3972759/

Using Motivational Interviewing to Enhance Treatment ... MI has been proven effective at promoting treatment adherence in other populations. For example, MI has motivated alcohol abusers to adhere to alcohol treatment ...

3. researchgate.net researchgate.net/publication/281876162_Integrating_Motivational_Interviewing_and_Brief_Behavioral_Activation_Therapy_Theoretical_and_Practical_Considerations

Integrating Motivational Interviewing and Brief Behavioral ... MI works to increase participants' intrinsic motivation for change and increase ambivalence about problematic behaviors like drinking (Rollnick ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714421003335

Study design and interventions for a peer-delivered ... This paper describes the rationale for and methodology of a randomized controlled trial comparing the effectiveness of Motivational Interviewing (MI) versus MI ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8200683/

Motivational Interviewing: An Evidence-Based Approach for ... Motivational interviewing (MI) is a technique that has been specifically developed to help motivate ambivalent patients to change their behavior.