Effectiveness & Cost-effectiveness of Internet-delivered Interventions for Depression and Anxiety Disorders in IAPT

NCT03188575 | Unknown DMC

• 1 other identifier: D-IAPT
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

Brief Summary

Depression and anxiety are common mental health problems. There are effective treatments for depression and anxiety and one of these is talking therapies using cognitive behaviour therapy (CBT). In recent years CBT has been transferred to online delivery methods and these interventions have proven successful for people being treated with symptoms of depression and anxiety. The current study will utilise a randomised controlled trial design, where the majority (n=240) of participants will be allocated to the immediate treatment (internet-delivered CBT for either depression or anxiety), and a smaller number (n=120) will be allocated to a waiting list. The waiting list group will receive treatment after an eight week wait. This design helps us to understand that any changes in symptoms in the treatment group will be likely due to the treatment they received compared to the waiting list. A sample size of 360 participants is proposed and has been adjusted to ameliorate against patient dropout. Follow-up and maintenance of any positive changes in symptoms is very important in CBT for depression and anxiety, simply because some people can have a relapse of symptoms. We will therefore follow-up the treatment group for 3, 6, 9 and 12 months to assess maintenance of positive gains from treatment. The study also seeks to investigate the cost effectiveness of the treatments.

Conditions

Depression; Anxiety Disorders; Depressive Disorder; Generalized Anxiety Disorder; Social Anxiety Disorder; Phobic Disorders; Panic Disorder; Health Anxiety

Outcome Measures

Primary Outcomes (2)

• Change in Depression symptoms

  Measured by the 9 item Patient Health Questionnaire (PHQ-9)

  Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up

• Change in Anxiety symptoms

  Measured by the 7 item Generalised Anxiety Disorder inventory (GAD-7)

  Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up

Secondary Outcomes (18)

• Work and Social Adjustment

  Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up

• Social Anxiety

  Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up

• Health Anxiety

  Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up

• Panic

  Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up

• Generalised Anxiety Symptoms

  Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up

Study Arms (2)

iCBT for Depression and Anxiety

EXPERIMENTAL

SilverCloud Internet-Delivered Cognitive Behavioural Therapy

Behavioral: SilverCloud Internet-delivered Cognitive Behavioural Therapy

Waiting List

ACTIVE COMPARATOR

Waiting list control

Other: Waiting List

Interventions

SilverCloud Internet-delivered Cognitive Behavioural Therapy BEHAVIORAL

SilverCloud Health is a leading provider of online therapeutic solutions to support and promote positive behavior change and mental wellness. SilverCloud delivers interventions for all of the anxiety disorders (panic disorder, social anxiety, phobias, GAD, health anxiety, OCD), depression and also comorbid depression and anxiety. The programs for the treatment of depression and anxiety employ several innovative engagement strategies for improving the user experience. These are divided into several categories: personal, interactive, supportive, and social. Research on the SilverCloud interventions has yielded significant clinical outcomes (Richards et al., 2015).

iCBT for Depression and Anxiety

Waiting List OTHER

8 week waiting list period.

Waiting List

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A score of ≥ 9 on PHQ-9 and/ or a score of ≥ 8 on GAD-7
• years of age
• Suitable for an internet-delivered intervention (iCBT)

You may not qualify if:

• Suicidal intent/ideation
• Psychotic illness
• Currently in psychological treatment for depression and/or anxiety
• Alcohol or drug misuse
• Previous diagnosis of an organic mental health disorder

Sponsors & Collaborators

• Silver Cloud Health: lead
• Berkshire Healthcare NHS Foundation Trust: collaborator

Study Sites (1)

Berkshire NHS Foundation Trust

Berkshire, United Kingdom

Location

Related Publications (2)

• Richards D, Timulak L, O'Brien E, Hayes C, Vigano N, Sharry J, Doherty G. A randomized controlled trial of an internet-delivered treatment: Its potential as a low-intensity community intervention for adults with symptoms of depression. Behav Res Ther. 2015 Dec;75:20-31. doi: 10.1016/j.brat.2015.10.005. Epub 2015 Oct 21.

  PMID: 26523885 BACKGROUND

• Richards D, Duffy D, Blackburn B, Earley C, Enrique A, Palacios J, Franklin M, Clarke G, Sollesse S, Connell S, Timulak L. Digital IAPT: the effectiveness & cost-effectiveness of internet-delivered interventions for depression and anxiety disorders in the Improving Access to Psychological Therapies programme: study protocol for a randomised control trial. BMC Psychiatry. 2018 Mar 2;18(1):59. doi: 10.1186/s12888-018-1639-5.

  PMID: 29499675 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Depressive Disorder; Generalized Anxiety Disorder; Phobia, Social; Phobic Disorders; Panic Disorder

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Derek Richards, PhD

  SilverCloud Health

  STUDY DIRECTOR

• Sarah Sollesse, MSc

  Berkshire Healthcare NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 15, 2017
• Study Start: June 15, 2017
• Primary Completion: July 25, 2019
• Study Completion: August 30, 2019
• Last Updated: September 10, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)