Text-Message CBT for Anxiety

Overseen By Michael J Mason, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Tennessee, Knoxville

Disqualifiers: Recent anxiety treatment, No phone, others

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

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

100 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. However, if you have been treated for anxiety in the past three months, you may not be eligible to participate.

What data supports the effectiveness of the treatment CBT-txt-Anxiety?

Research shows that using text messages to support cognitive-behavioral therapy (CBT) can help improve mental health care by increasing engagement and tracking progress, especially in low-income populations. Additionally, studies have found that technology-supported CBT can be effective for anxiety disorders, suggesting that text-message CBT might also be beneficial. ^{1 2 3 4 5}

Is text-message CBT for anxiety safe for humans?

Research on internet-delivered CBT, which is similar to text-message CBT, shows that while it is generally safe, some people may experience negative effects like technical issues or emotional distress. However, severe adverse events were not reported, suggesting it is generally safe for most users. ^{1 3 5 6 7}

How is the CBT-txt-Anxiety treatment different from other anxiety treatments?

CBT-txt-Anxiety is unique because it delivers cognitive behavioral therapy (CBT) through text messages, making it more accessible and convenient for real-life situations compared to traditional in-person therapy. This approach can help increase adherence to therapy and track progress in a cost-effective way, especially for low-income populations. ^{1 3 5 8 9}

What is the purpose of this trial?

The purpose of the proposed study is to test the feasibility and efficacy of a "anxiety-focused" text-delivered counseling program to reduce anxiety symptoms among young adults (18-25) with elevated anxiety symptoms. We are primarily interested in whether the intervention will reduce anxiety. We have adapted an effective in-person, manualized cognitive behavioral therapy treatment for anxiety (Muñoz et al, 2000) into an 8-week, text-delivered anxiety treatment, named CBT-txt-Anxiety. We will test this with 100 young adults who will be randomized to either CBTtxt-Anxiety or waitlist control condition and assessed at baseline, and at 1- month, 2-months, and 3-months post-baseline.

Eligibility Criteria

This trial is for young adults aged 18-25 who are experiencing elevated anxiety symptoms. Participants must be willing to engage with a text-message-based therapy program and available for follow-up assessments. Specific inclusion or exclusion criteria details were not provided.

Inclusion Criteria

GAD-7 score of at least 10 (indicating elevated anxiety symptoms)

Resides in the United States

Consents to receiving text messages from the study

Exclusion Criteria

I am not fluent in English.

Lack of access to a text-capable phone

Unable or unwilling to commit to three months of follow-up

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete an online baseline survey via Qualtrics

1 day

1 virtual visit

Treatment

Participants receive 32 text conversations over a 60-day period as part of the CBT-txt-Anxiety intervention

8 weeks

Daily virtual interactions

Follow-up

Participants are monitored for changes in anxiety symptoms through online surveys at 1-, 2-, and 3-months post-baseline

3 months

3 virtual visits

Treatment Details

Interventions

• CBT-txt-Anxiety

Trial Overview The study is testing CBT-txt-Anxiety, an 8-week cognitive behavioral therapy program delivered through text messages, designed to reduce anxiety in young adults. It will compare the effectiveness of this intervention against a waitlist control group over several months.

Participant Groups

Group I: CBT-txt-A Experimental Treatment 1 Intervention

8-week automated text-message delivered treatment for Generalized Anxiety Disorder

Group II: Control Active Control 1 Intervention

Assessment only condition

Who Is Running the Clinical Trial?

The University of Tennessee, Knoxville

Lead Sponsor

Trials

93

Recruited

19,500+

Findings from Research

The study developed a protocol for evaluating the effectiveness of cell phone-supported cognitive behavioral therapy (CBT) for managing anxiety disorders in real-world clinical settings, addressing the limitations of traditional randomized controlled trials.

Key aspects of the protocol include analyzing therapist roles and ensuring adherence to treatment, which will help identify effective CBT methods that can be integrated into health services more broadly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cell phone-supported cognitive behavioural therapy for anxiety disorders: a protocol for effectiveness studies in frontline settings. Ekberg, J., Timpka, T., Bång, M., et al.[2021]

The study involved 68 participants who received individually tailored text messages alongside telephone-based psychotherapy, but there were no significant differences in clinical outcomes compared to a historical control group of 157 participants who only received psychotherapy.

While both groups showed improvement over time, the SMS intervention did not enhance clinical outcomes, and the study suggests that further research with a larger sample size is needed to better assess the potential benefits of text messaging in psychotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison between phone-based psychotherapy with and without text messaging support in between sessions for crisis patients. Furber, G., Jones, GM., Healey, D., et al.[2021]

An automated text-messaging system was developed to support cognitive-behavioral therapy (CBT) for depression, focusing on enhancing homework adherence and tracking patient progress among low-income patients.

In a feasibility test with 12 participants in two CBT groups, the system achieved a 65% response rate to daily mood inquiries and received positive feedback, suggesting it could be a cost-effective tool to improve mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text Messaging as an Adjunct to CBT in Low-Income Populations: A Usability and Feasibility Pilot Study. Aguilera, A., Muñoz, RF.[2022]

The study involved 755 depressed patients and demonstrated that an automated SMS system for weekly depression monitoring was feasible and well-accepted, with a high response rate of 94.5% among participants who consented.

The SMS depression rating scale showed a moderate to high correlation with the established PHQ-9 scale and was more responsive to treatment changes, indicating its potential as a valid and sensitive tool for tracking depression in clinical research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability and validity of SMS text messaging for measuring change in depression during a randomised controlled trial. Richmond, SJ., Keding, A., Hover, M., et al.[2018]

This study will evaluate the effectiveness of a smartphone-supplemented internet-administered cognitive behavioral therapy (iCBT) program for anxiety disorders, involving 150 participants diagnosed with social anxiety disorder and/or panic disorder.

The trial will compare three groups: one receiving iCBT with therapist support, one without support, and a control group, assessing outcomes over time to determine both immediate and long-term effects of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided and unguided CBT for social anxiety disorder and/or panic disorder via the Internet and a smartphone application: study protocol for a randomised controlled trial. Lindner, P., Ivanova, E., Ly, KH., et al.[2022]

In a study of 96 clients undergoing internet-delivered cognitive behaviour therapy (ICBT), 61.5% reported experiencing at least one negative effect during treatment, highlighting the importance of monitoring these effects in real-time rather than relying solely on post-treatment reports.

Common negative effects included technical difficulties and negative emotional states, but serious adverse events like symptom deterioration were not reported, suggesting that while ICBT is generally effective, there are still challenges that need to be addressed to improve client experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative effects associated with internet-delivered cognitive behaviour therapy: An analysis of client emails. Gullickson, KM., Hadjistavropoulos, HD., Dear, BF., et al.[2020]

Internet- and computer-based cognitive-behavioral treatments (ICT) have been shown to be effective in reducing anxiety, with effect sizes ranging from 0.49 to 1.14 compared to waitlist and placebo groups, based on a review of 19 randomized controlled trials.

The efficacy of ICT is comparable to traditional therapist-delivered treatments across various anxiety disorders, although the findings are limited by small sample sizes and methodological issues, highlighting the need for larger, well-designed studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of the effects of internet- and computer-based cognitive-behavioral treatments for anxiety. Reger, MA., Gahm, GA.[2022]

In a study analyzing 712 emails from therapists to 71 participants in a randomized controlled trial of internet-based cognitive behavioral therapy (CBT) for bulimic disorders, 95.4% of the emails contained supportive comments, highlighting the emphasis on encouragement in therapeutic communication.

Only 14.7% of the emails included specific CBT comments, suggesting that while therapists provided substantial emotional support, there was limited direct application of CBT techniques in their email interactions, with an average of 45 minutes spent on email support per participant throughout the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of email guidance in internet-based cognitive-behavioural self-care treatment for bulimia nervosa. Sánchez-Ortiz, VC., Munro, C., Startup, H., et al.[2022]

A pilot study involving 85 participants found that internet-delivered cognitive behavior therapy (ICBT) significantly improved worry and anxiety symptoms in individuals with generalized anxiety disorder (GAD), with moderate to large effect sizes on the primary measure of worry.

Both worry-specific and self-tailored ICBT treatments were effective, and while participants preferred scheduled support over on-demand support, there were no significant differences in outcomes between the treatment groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Worry-specific versus self-tailored internet-based treatments for generalized anxiety disorder, with scheduled support or support on demand: A pilot factorial design trial. Dahlin, M., Johansson, A., Romare, H., et al.[2022]

References

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

Cell phone-supported cognitive behavioural therapy for anxiety disorders: a protocol for effectiveness studies in frontline settings. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

A comparison between phone-based psychotherapy with and without text messaging support in between sessions for crisis patients. [2021]

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

Text Messaging as an Adjunct to CBT in Low-Income Populations: A Usability and Feasibility Pilot Study. [2022]

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

Feasibility, acceptability and validity of SMS text messaging for measuring change in depression during a randomised controlled trial. [2018]

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

Guided and unguided CBT for social anxiety disorder and/or panic disorder via the Internet and a smartphone application: study protocol for a randomised controlled trial. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Negative effects associated with internet-delivered cognitive behaviour therapy: An analysis of client emails. [2020]

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

A meta-analysis of the effects of internet- and computer-based cognitive-behavioral treatments for anxiety. [2022]

8. England pubmed.ncbi.nlm.nih.gov

The role of email guidance in internet-based cognitive-behavioural self-care treatment for bulimia nervosa. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Worry-specific versus self-tailored internet-based treatments for generalized anxiety disorder, with scheduled support or support on demand: A pilot factorial design trial. [2022]