Internet Cognitive Behavioral Therapy for Depression
(ADEPT-ICU Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byBabar Khan, MD, MS
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Indiana University
Must not be taking: Anti-dementia medications
Disqualifiers: Dementia, Severe mental illness, Stroke, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
26789How 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.
7891011Eligibility 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.
+4 more
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
+6 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention - Internet Cognitive-Behavioral Therapy (CBT) for DepressionExperimental Treatment1 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 CareActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Eskenazi HospitalIndianapolis, IN
IU Health Methodist HospitalIndianapolis, IN
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Who Is Running the Clinical Trial?
Indiana UniversityLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Adding an App-Based Intervention to the Cognitive Behavioral Analysis System of Psychotherapy in Routine Outpatient Psychotherapy Treatment: Proof-of-Concept Study. [2022]The Cognitive Behavioral Analysis System of Psychotherapy (CBASP) is an empirically supported psychotherapeutic treatment developed specifically for persistent depressive disorder. However, given the high rates of nonresponse and relapse, there is a need for optimization. Studies suggest that outcomes can be improved by increasing the treatment dose via, for example, the continuous web-based application of therapy strategies between sessions. The strong emphasis in CBASP on the therapeutic relationship, combined with limited therapeutic availabilities, encourages the addition of web-based interventions to face-to-face therapy in terms of blended therapy.
[Can we do therapy without a therapist? Active components of computer-based CBT for depression]. [2018]Computer-delivered Cognitive Behavioral Therapies (C-CBT) are emerging as therapeutic techniques which contribute to overcome the barriers of health care access in adult populations with depression. The C-CBTs provide CBT techniques in a highly structured format comprising a number of educational lessons, homework, multimedia illustrations and supplementary materials via interactive computer interfaces. Programs are often administrated with a minimal or regular support provided by a clinician or a technician via email, telephone, online forums, or during face-to-face consultations. However, a lot of C-CBT is provided without any therapeutic support. Several reports showed that C-CBTs, both guided or unguided by a therapist, may be reliable and effective for patients with depression, and their use was recommended as part of the first step of the clinical care. The aim of the present qualitative review is to describe the operational format and functioning of five of the most cited unguided C-CBT programs for depression, to analyze their characteristics according to the CBT's principles, and to discuss the results of the randomized clinical trials (RCT) conducted to evaluate its effectiveness, adherence and user's experience.
Free choice of treatment content, support on demand and supervision in internet-delivered CBT for adults with depression: A randomized factorial design trial. [2023]Even if much is known regarding the effects of internet-delivered cognitive behaviour therapy (ICBT) for depression there are several topics that have not been studied. In this factorial design trial with 197 participants we investigated if clients in ICBT could select treatment modules themselves based on a selection of 15 tailored treatment modules developed for use in ICBT for depression. We contrasted this against clinician-tailored module selection. We also investigated if support on demand (initiated by the client) could work as well as scheduled support. Finally, we tested if clients that were mentioned in supervision would improve more than clients not mentioned (with the exception of acute cases). The treatment period lasted for 10 weeks, and we measured effects at post-treatment and two-year follow-up. Measures of depression and secondary outcomes were collected at pre-treatment, post-treatment and two-year follow-up. Overall, within-group effects were large across conditions (e.g., d = 1.73 on the BDI-II). We also found a small but significant difference in favour of self-tailored treatment over clinician-tailored (d = 0.26). Within-group effects for the secondary measures were all moderate to large including a test of knowledge about CBT. The other two contrasts "support on demand" and "supervision" yielded mostly non-significant differences, with the exception of a larger dropout rate in the support on demand condition. There were few negative effects (2.2%). Effects were largely maintained at a two-year follow-up. We conclude that clients can choose treatment modules and that support on demand may work. The role of supervision is not yet clear as advice can be transferred across clients.
Computer-aided psychological treatments: evolving issues. [2022]Evidence is growing that several computer-aided psychotherapy (CP) systems can effectively improve a range of common mental health problems. Most clients find CP acceptable because of its convenience, confidentiality, and reduction of stigma. CP can be accessed in a clinic, but recently clients have used CP especially on the Internet at home, with brief support on a telephone helpline and/or by email. Brief and efficient screening and support greatly reduce attrition. CP's efficacy, and encouragement of its dissemination and implementation by some national funding bodies and governmental agencies, has led to its spread as a regular care option and is increasing access to psychological therapies in some countries. Transfer of this new approach from use in tight research studies to use as an integrated part of everyday care under widely varying conditions generates teething problems that are being managed in diverse ways across different centers. Anonymized Internet audit of CP outcomes facilitates effective care and clinical governance. This review examines the current state of the art as well as the science and broad applications of CP.
Feasibility study of an interactive multimedia electronic problem solving treatment program for depression: a preliminary uncontrolled trial. [2021]Computer-based depression interventions lacking live therapist support have difficulty engaging users. This study evaluated the usability, acceptability, credibility, therapeutic alliance and efficacy of a stand-alone multimedia, interactive, computer-based Problem Solving Treatment program (ePST™) for depression. The program simulated live treatment from an expert PST therapist, and delivered 6 ePST™ sessions over 9weeks. Twenty-nine participants with moderate-severe symptoms received the intervention; 23 completed a minimally adequate dose of ePST™ (at least 4 sessions). Program usability, acceptability, credibility, and therapeutic alliance were assessed at treatment midpoint and endpoint. Depressive symptoms and health-related functioning were assessed at baseline, treatment midpoint (4weeks), and study endpoint (10weeks). Depression outcomes and therapeutic alliance ratings were also compared to previously published research on live PST and computer-based depression therapy. Participants rated the program as highly usable, acceptable, and credible, and reported a therapeutic alliance with the program comparable to that observed in live therapy. Depressive symptoms improved significantly over time. These findings also provide preliminary evidence that ePST™ may be effective as a depression treatment. Larger clinical trials with diverse samples are indicated.
Efficacy of Self-guided Internet-Based Cognitive Behavioral Therapy in the Treatment of Depressive Symptoms: A Meta-analysis of Individual Participant Data. [2022]Self-guided internet-based cognitive behavioral therapy (iCBT) has the potential to increase access and availability of evidence-based therapy and reduce the cost of depression treatment.
Internet-based cognitive behavior therapy for major depressive disorder: A randomized controlled trial. [2018]Prior research has shown that the Sadness Program, a technician-assisted Internet-based cognitive behavioral therapy (iCBT) intervention developed in Australia, is effective for treating major depressive disorder (MDD). The current study aimed to expand this work by adapting the protocol for an American population and testing the Sadness Program with an attention control group.
[Internet-based cognitive-behavioral therapy in the treatment of psychiatric disorders]. [2022]Recent years have seen the development of Internet-based cognitive-behavioral therapy, i.e. psychological self-help program mediated via the Internet, the patient being in contact via e-mail with the support person directing the therapy. Internet-based cognitive-behavioral therapy usually consists of psychoeducation, exercises and prevention of the recurrence of symptoms. Modules of the network program are thus the cornerstones of "live" cognitive-behavioral therapy. Self-help provided by Internet-based cognitive-behavioral therapy therapy has been found to be effective especially in the treatment of panic disorder, social phobia and depression, providing an opportunity to extend therapeutic services also to persons beyond the reach of traditional therapy.
Online cognitive behavioral therapy for depressed primary care patients: a pilot feasibility project. [2021]Cognitive behavioral therapy (CBT) is a goal-oriented treatment that guides patients to healthy thoughts and behaviors. Internet-delivered CBT with supportive coaching can be as effective as in-person psychotherapy treatment of depression.
Overcoming Depression on the Internet (ODIN) (2): a randomized trial of a self-help depression skills program with reminders. [2022]Guided self-help programs for depression (with associated therapist contact) have been successfully delivered over the Internet. However, previous trials of pure self-help Internet programs for depression (without therapist contact), including an earlier trial conducted by us, have failed to yield positive results. We hypothesized that methods to increase participant usage of the intervention, such as postcard or telephone reminders, might result in significant effects on depression.
Components of smartphone cognitive-behavioural therapy for subthreshold depression among 1093 university students: a factorial trial. [2023]Internet-based cognitive-behavioural therapy (iCBT) is effective for subthreshold depression. However, which skills provided in iCBT packages are more effective than others is unclear. Such knowledge can inform construction of more effective and efficient iCBT programmes.