Internet Cognitive Behavioral Therapy for Depression

(ADEPT-ICU Trial)

Recruiting at 1 trial location

Overseen By Lori Rawlings, RN, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: Anti-dementia medications

Disqualifiers: Dementia, Severe mental illness, Stroke, others

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

Compensation: Varies

Number of Visits: 15

Duration: 6 months

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. However, if you are on anti-dementia medications, you would not be eligible to participate.

What data supports the effectiveness of the treatment Internet Cognitive Behavioral Therapy for Depression?

Research shows that internet-delivered cognitive behavioral therapy (ICBT) can effectively reduce depression symptoms, with large improvements seen in studies. Additionally, computer-based cognitive behavioral therapies (C-CBT) have been found to be reliable and effective for depression, even without therapist support, making them a recommended part of depression care. ^{1 2 3 4 5}

Is Internet Cognitive Behavioral Therapy for Depression safe for humans?

Internet-based cognitive behavioral therapy (iCBT) has been used safely for treating depression and other conditions like panic disorder and social phobia. It is generally considered safe and effective, whether guided by a therapist or self-guided. ^{2 6 7 8 9}

How is Therapist-Assisted Internet Cognitive-Behavioral Therapy for Depression different from other treatments?

This treatment is unique because it combines online cognitive behavioral therapy (CBT) with support from a therapist, making it as effective as in-person therapy for depression. It offers the convenience of internet access while still providing personal guidance, which is not available in pure self-help internet programs. ^{7 8 9 10 11}

What is the purpose of this trial?

Depression affects one-third of intensive care unit (ICU) survivors and represents a potentially modifiable target to slow cognitive decline and reduce the risk of Alzheimer's disease and related dementias (ADRD). Our multi-PI team proposes a two-arm RCT called ADEPT-ICU (Attenuating DEPression with Internet CBT to Slow Cognitive Decline in Older ICU Survivors), which will test the efficacy of an internet CBT intervention called Good Days Ahead (GDA) to reduce the burden of subjective cognitive decline (SCD) in older ICU survivors with moderate to severe depressive symptoms after ICU hospitalization.

Research Team

Babar Khan, MD, MS

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for older individuals who survived an ICU stay and are experiencing moderate to severe depression, which may contribute to cognitive decline. The goal is to see if treating depression can slow down memory and thinking problems that sometimes lead to dementia.

Inclusion Criteria

I have been in the ICU for more than 48 hours.

I am willing to undergo tests that assess my thinking and memory.

I will be discharged to my home or a facility where I can live with some assistance.

Exclusion Criteria

Recent or recurrent alcohol or substance use disorder as per HER and Drug Abuse Screening Test

Diagnosis of severe mental illness (bipolar disorder, schizophrenia, schizoaffective) as per EHR and screening questions

Persistent psychotic symptoms after ICU stay which would interfere with successful completion of intervention

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive internet CBT for depression or active control over six months

6 months

9 sessions (virtual) with therapist assistance

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at 6-month and 12-month follow-up

Treatment Details

Interventions

• Active Control
• Therapist-Assisted Internet Cognitive-Behavioral Therapy for Depression

Trial Overview The ADEPT-ICU study compares two groups: one receives Internet Cognitive-Behavioral Therapy (CBT) specifically designed for depression called Good Days Ahead (GDA), while the other group participates in a control activity not specified here.

Participant Groups

Group I: Intervention - Internet Cognitive-Behavioral Therapy (CBT) for Depression Experimental Treatment 1 Intervention

Participants will complete nine 45-minute sessions of an internet CBT for depression called Good Days Ahead (GDA; MindStreet, Inc.) with 20 minutes of therapist assistance per session on the phone over six months.

Group II: Active Control - Depression Education, Symptom Monitoring, and Usual Care Active Control 1 Intervention

Participants will review nine 45-minute segments of depression education material on their own with 20 minutes of therapist assistance per segment on the phone over six months. They will also have access to and could receive current depression care in the targeted healthcare systems.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

The pilot study of the CBASPath app, used as a blended therapy tool alongside traditional Cognitive Behavioral Analysis System of Psychotherapy (CBASP), showed that 93% of participants engaged with the app, indicating its feasibility in routine outpatient care for persistent depressive disorder.

Participants reported high satisfaction and usability with CBASPath, suggesting that digital tools can enhance therapy engagement and potentially improve treatment outcomes, although a randomized controlled trial is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adding an App-Based Intervention to the Cognitive Behavioral Analysis System of Psychotherapy in Routine Outpatient Psychotherapy Treatment: Proof-of-Concept Study. Netter, AL., Beintner, I., Brakemeier, EL.[2022]

Computer-delivered Cognitive Behavioral Therapies (C-CBT) are effective for treating depression, showing high effectiveness and adherence among self-referred individuals, based on a review of 22 randomized controlled studies.

Therapist support significantly enhances the effectiveness and adherence of C-CBT, particularly for outpatients referred by clinicians, highlighting the importance of integrating some level of guidance in these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Can we do therapy without a therapist? Active components of computer-based CBT for depression]. Iakimova, G., Dimitrova, S., Burté, T.[2018]

In a trial with 197 participants over 10 weeks, clients who selected their own treatment modules in internet-delivered cognitive behavior therapy (ICBT) showed a small but significant improvement in depression compared to those with clinician-tailored modules, indicating that personalized treatment can enhance efficacy.

The study found that while support on demand (initiated by clients) was generally effective, it resulted in a higher dropout rate, suggesting that while flexibility in support may be beneficial, it needs careful management to ensure client retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Free choice of treatment content, support on demand and supervision in internet-delivered CBT for adults with depression: A randomized factorial design trial. Andersson, G., Käll, A., Juhlin, S., et al.[2023]

Computer-aided psychotherapy (CP) systems have been shown to effectively improve various mental health issues, with many clients appreciating the convenience and confidentiality they offer, especially when accessed online.

The integration of CP into regular care has been supported by national funding bodies, increasing access to psychological therapies, although challenges remain in adapting these systems for everyday use across different settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-aided psychological treatments: evolving issues. Marks, I., Cavanagh, K.[2022]

The ePST™ program, a stand-alone multimedia interactive treatment for depression, was well-received by participants, who found it highly usable, acceptable, and credible, with a therapeutic alliance comparable to live therapy.

Among the 29 participants, those who completed at least 4 sessions showed significant improvement in depressive symptoms over the 10-week study, suggesting that ePST™ may be an effective treatment option for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility study of an interactive multimedia electronic problem solving treatment program for depression: a preliminary uncontrolled trial. Berman, MI., Buckey, JC., Hull, JG., et al.[2021]

Self-guided internet-based cognitive behavioral therapy (iCBT) significantly reduces depressive symptoms compared to control groups, with a moderate effect size indicating its efficacy as a treatment option.

The study analyzed data from 3876 participants across 13 trials, showing that adherence to iCBT is linked to better treatment outcomes, suggesting that engagement with the program is crucial for effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Self-guided Internet-Based Cognitive Behavioral Therapy in the Treatment of Depressive Symptoms: A Meta-analysis of Individual Participant Data. Karyotaki, E., Riper, H., Twisk, J., et al.[2022]

The Sadness Program, an Internet-based cognitive behavioral therapy (iCBT) intervention, significantly reduced depressive symptoms in adults with major depressive disorder (MDD) compared to an attention control group, with a large effect size (d = -0.80).

Participants in the iCBT group also experienced higher rates of clinical response and remission, suggesting that this scalable and cost-efficient treatment could enhance access to effective mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based cognitive behavior therapy for major depressive disorder: A randomized controlled trial. Rosso, IM., Killgore, WD., Olson, EA., et al.[2018]

Internet-based cognitive-behavioral therapy (CBT) is an effective self-help program that allows patients to receive psychological support via the Internet, making therapy more accessible, especially for those unable to attend traditional sessions.

This form of therapy has shown particular effectiveness in treating conditions like panic disorder, social phobia, and depression, indicating its potential to reach and help a wider range of individuals in need of mental health support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Internet-based cognitive-behavioral therapy in the treatment of psychiatric disorders]. Holmberg, N., Kähkönen, S.[2022]

A pilot study involving 196 primary care patients found that 20% enrolled in an Internet-delivered cognitive behavioral therapy (CBT) program, indicating that integrating such programs into healthcare systems is feasible.

Participants who completed the program experienced a significant average reduction of 46% in depressive symptoms after four months, along with a decrease in suicidal thoughts, suggesting that Internet-delivered CBT can be an effective treatment for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online cognitive behavioral therapy for depressed primary care patients: a pilot feasibility project. Whiteside, U., Richards, J., Steinfeld, B., et al.[2021]

A randomized trial involving 255 participants showed that a pure self-help Internet program for depression, called ODIN, significantly reduced depression symptoms compared to a usual treatment control group, especially among those with more severe depression at the start.

Participants who received reminders (via postcards or phone calls) to use the ODIN program reported greater improvements, indicating that increasing engagement through reminders can enhance the effectiveness of online self-help interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overcoming Depression on the Internet (ODIN) (2): a randomized trial of a self-help depression skills program with reminders. Clarke, G., Eubanks, D., Reid, E., et al.[2022]

A study involving 1,093 university students with subthreshold depression found that all participants experienced significant reductions in depression symptoms after 8 weeks of internet-based cognitive-behavioral therapy (iCBT), regardless of which specific skills were included in their treatment.

No specific iCBT component (like self-monitoring, behavioral activation, cognitive restructuring, assertiveness training, or problem-solving) showed a clear advantage over others in reducing depression, indicating that the overall iCBT approach is effective but the individual components may not be critical for success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Components of smartphone cognitive-behavioural therapy for subthreshold depression among 1093 university students: a factorial trial. Sakata, M., Toyomoto, R., Yoshida, K., et al.[2023]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Adding an App-Based Intervention to the Cognitive Behavioral Analysis System of Psychotherapy in Routine Outpatient Psychotherapy Treatment: Proof-of-Concept Study. [2022]

2. France pubmed.ncbi.nlm.nih.gov

[Can we do therapy without a therapist? Active components of computer-based CBT for depression]. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Free choice of treatment content, support on demand and supervision in internet-delivered CBT for adults with depression: A randomized factorial design trial. [2023]

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

Computer-aided psychological treatments: evolving issues. [2022]

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

Feasibility study of an interactive multimedia electronic problem solving treatment program for depression: a preliminary uncontrolled trial. [2021]

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

Efficacy of Self-guided Internet-Based Cognitive Behavioral Therapy in the Treatment of Depressive Symptoms: A Meta-analysis of Individual Participant Data. [2022]

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

Internet-based cognitive behavior therapy for major depressive disorder: A randomized controlled trial. [2018]

8. Finland pubmed.ncbi.nlm.nih.gov

[Internet-based cognitive-behavioral therapy in the treatment of psychiatric disorders]. [2022]

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

Online cognitive behavioral therapy for depressed primary care patients: a pilot feasibility project. [2021]

10. Canada pubmed.ncbi.nlm.nih.gov

Overcoming Depression on the Internet (ODIN) (2): a randomized trial of a self-help depression skills program with reminders. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Components of smartphone cognitive-behavioural therapy for subthreshold depression among 1093 university students: a factorial trial. [2023]