Cognitive Behavioral Therapy for Mental Health Issues

Overseen By Jonathan Singer, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Texas Tech University

Disqualifiers: Other clinical intervention

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of Cognitive Behavioral Therapy (CBT), a proven treatment for mental health issues, on its own compared to CBT with two additional check-in calls each week. The focus is on adults living in rural Texas who care for someone with dementia. One group will receive standard CBT, while the other will receive CBT plus the extra support from the check-in calls. This study is ideal for family caregivers not currently involved in another clinical intervention. As an unphased trial, it offers caregivers a unique opportunity to explore enhanced support options tailored to their needs.

Do I need to stop taking my current medications for this trial?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cognitive Behavioral Therapy (CBT) is a safe and effective treatment for mental health issues such as depression and anxiety. Many studies have found that CBT helps individuals change negative thinking patterns and improve mental well-being.

The addition of check-in calls to CBT is a new area under exploration. Although data on this combination remains limited, CBT alone is well-researched and considered low-risk. The check-in calls are expected to offer extra support without significantly increasing risk.

Overall, CBT is generally well-received, with no serious side effects reported in studies. People often find it helpful for managing mental health challenges. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they explore how enhancing Cognitive Behavioral Therapy (CBT) with additional support can improve mental health outcomes. Unlike standard CBT, which is typically delivered in weekly sessions, one treatment arm adds twice-weekly check-in calls. This added feature aims to provide continuous support and potentially increase therapy effectiveness by reinforcing therapeutic strategies and maintaining patient motivation between sessions. By testing these variations, researchers hope to discover whether these extra touches can make a significant difference in managing mental health issues.

What evidence suggests that this trial's treatments could be effective for mental health conditions?

Research has shown that Cognitive Behavioral Therapy (CBT), one of the treatments in this trial, effectively treats mental health issues such as anxiety and depression. Studies indicate that CBT improves symptoms in about 42% of individuals and provides long-term benefits. In this trial, some participants will receive CBT along with regular check-in calls. When paired with these check-in calls, about 50% of individuals with depression, anxiety, or OCD experience improvement. This suggests that adding check-ins can enhance CBT's effectiveness. Overall, CBT is a well-supported method for managing mental health problems. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults living in rural Texas who are looking to improve their quality of life and mental health. The specific details about who can join or reasons someone might not be eligible are not provided.

Inclusion Criteria

Family caregiver of a person with all forms of dementia

Exclusion Criteria

Not in another clinical intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Cognitive Behavioral Therapy, with one group receiving additional twice-weekly check-in calls

4 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Monthly assessments

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy
• Cognitive Behavioral Therapy with 2 check-in calls

Trial Overview The study is testing the effectiveness of Cognitive Behavioral Therapy (CBT) alone versus CBT with two additional check-in calls per week, to see which better improves quality of life and mental health issues for participants.

How Is the Trial Designed?

Group I: Cognitive Behavior Therapy plus 2 check-in calls a week Experimental Treatment 1 Intervention

This arm will provide the same as the first with the addition of twice-weekly check-in calls between sessions.

Group II: Cognitive Behavior Therapy Experimental Treatment 1 Intervention

Cognitive Behavior Therapy is an evidence-based practice for mental health conditions and has been shown in numerous studies around the world to be effective.

Who Is Running the Clinical Trial?

Texas Tech University

Lead Sponsor

Trials

89

Recruited

10,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8489050/

Cognitive–behavioral therapy for management of mental ... The results of several randomized controlled trials indicated that CBT was effective for a variety of mental problems (e.g., anxiety disorder, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3584580/

The Efficacy of Cognitive Behavioral Therapy: A Review ... CBT showed higher response rates than the comparison conditions in 7 of these reviews and only one review reported that CBT had lower response rates than ...

3. crowncounseling.com crowncounseling.com/statistics/cbt-success-rate-statistics/

CBT Success Rate Statistics: Effectiveness of CBT in 2024 Explore comprehensive CBT success rate statistics showing 42% response rates and long-term effectiveness across various mental health ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0005796725000130

Effectiveness of cognitive behavioral therapy for adult ... For depressive symptoms, recovery rates ranged from 40.8% (n = 51) in patients with four diagnoses to 56.9% (n = 1247) in patients with one baseline diagnosis ( ...

5. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/article-abstract/2832696

Cognitive Behavior Therapy for Mental Disorders in Adults In this unified series of meta-analyses, CBT was probably effective in the treatment of mental disorders, including major depression, anxiety disorders, PTSD, ...

6. mayoclinic.org mayoclinic.org/tests-procedures/cognitive-behavioral-therapy/about/pac-20384610

Cognitive behavioral therapy CBT can be a very helpful tool in treating many mental health conditions, such as depression, anxiety, post-traumatic stress disorder, also ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024137942

From theory to practice: Revealing the real-world impact of ... Cognitive behavior therapy (CBT) is a proven treatment for many psychological disorders. It has been extensively studied and is effective for anxiety, ...

8. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.focus.20200045

Cognitive-Behavioral Treatments for Anxiety and Stress- ... I-CBT has been shown (17–19) to be superior to waitlist and placebo conditions in the treatment of adults with a range of anxiety and trauma ...