Depression Clinical Trial
— D-IAPTOfficial title:
Digital IAPT: The Effectiveness & Cost-effectiveness of Internet-delivered Interventions for Depression and Anxiety Disorders in the Improving Access to Psychological Therapies Programme
Verified date | September 2018 |
Source | Silver Cloud Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 384 |
Est. completion date | August 30, 2019 |
Est. primary completion date | July 25, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. A score of = 9 on PHQ-9 and/ or a score of = 8 on GAD-7 2. 18 years of age 3. Suitable for an internet-delivered intervention (iCBT) Exclusion Criteria: 1. Suicidal intent/ideation 2. Psychotic illness 3. Currently in psychological treatment for depression and/or anxiety 4. Alcohol or drug misuse 5. Previous diagnosis of an organic mental health disorder |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Berkshire NHS Foundation Trust | Berkshire |
Lead Sponsor | Collaborator |
---|---|
Silver Cloud Health | Berkshire Healthcare NHS Foundation Trust |
United Kingdom,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Work and Social Adjustment | Measured using the Work and Social Adjustment scale (WSAS) | 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 | Social Anxiety | Measured using the Social Phobia Inventory (SPIN) | 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 | Health Anxiety | Measured using the Short Health Anxiety Inventory (SHAI) | 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 | Panic | Measured using the Panic Disorder Severity Scale (PDSS) | 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 | Generalised Anxiety Symptoms | Measured using the Penn State Worry Questionnaire (PSWQ) | 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 | Quality of life | Measured using the EQ5D5L | baseline, 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up | |
Secondary | Quality of life for users of mental health services | Measured using the Re-QOL | baseline, 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up | |
Secondary | Client service usage | Measured using the Client Services Receipt Inventory (CSRI) | baseline, 8 weeks, 6 month follow-up, 9 month follow-up and 12 month follow-up | |
Secondary | Emotion Regulation | Measured using the Emotion Regulation Questionnaire (ERQ) | Baseline and 8 weeks | |
Secondary | Rumination | Measured using the Positive Beliefs about Depressive Rumination scale (PBRS-A) | Baseline and 8 weeks | |
Secondary | Therapeutic Expectancy | Measured using the Expectancy/Credibility scale (TEQ) | Baseline, 4 weeks and 8 weeks. | |
Secondary | CBT Skills Usage | Measured using the Frequency of Actions and Thoughts scale (FATS) | 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up | |
Secondary | Therapist Behaviours | Measured using the Therapist Behaviours Checklist (TBCL) | Continuous during treatment after each session for 8 weeks | |
Secondary | Therapeutic Alliance for patients | Measured using the Scale to Assess Therapeutic Relationships - Patient Version (STAR-P) | Continuous during treatment after each session for 8 weeks | |
Secondary | Therapeutic Alliance for clinicians | Measured using the Scale to Assess Therapeutic Relationships - Clinician version (STAR-C) | Continuous during treatment after each session for 8 weeks | |
Secondary | Therapeutic Alliance for clinicians | Semi-structured interview will be employed to assess qualitatively clinicians experience of the therapeutic relationship online. | During the patient recruitment period. | |
Secondary | M.I.N.I. International Neuropsychiatric Interview | Used to determine a diagnosis of depression and/or anxiety (MINI) | Baseline and 3-month follow-up | |
Secondary | Patient Experience/Satisfaction | Measured using the Patient Experience Questionnaire (PEQ) | Post treatment (up to 8 weeks). |
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