- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04009135
The Internet Therapy for Depression Trial (INTEREST)
September 15, 2021 updated by: Joshua Rash, Memorial University of Newfoundland
The Internet Therapy for Depression Trial (INTEREST): A Doubly-randomized, Patient-preference, Controlled Feasibility Trial Comparing iACT, iCBT, and Attention Control
The objective of this trial is to collect data on the feasibility, acceptability, and preliminary effectiveness of internet delivered Cognitive Beaviour Therapy (iCBT) and Acceptance and Commitment Therapy (iACT) interventions tailored towards the treatment of depression and chronic pain using a doubly-randomized, attention-controlled, non-blinded, patient-preference design.
Study Overview
Status
Completed
Conditions
Detailed Description
The primary objective is to collect data on the feasibility, acceptability, and preliminary effectiveness of internet delivered Cognitive Beaviour Therapy (iCBT) and Acceptance and Commitment Therapy (iACT) on depressed mood among individuals with chronic pain relative to attention control (AC).
The secondary objectives are to evaluate the efficacy of iCBT and iACT on clinically relevant outcomes endorsed by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT).
Adults with chronic non-cancer pain and major depression will be randomized to receive iACT, iCBT, or AC.
The interventions comprise 7 weekly online modules available through Therapist Assisted Online (TAO).
Patients will be contacted weekly by a member of the study team who will be acting as their personalized "online therapy coach."
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Newfoundland and Labrador
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Saint John's, Newfoundland and Labrador, Canada, A1B3X9
- Memorial University of Newfoundland
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Fluent in English
- 18 years of age or older
- have a primary diagnosis of chronic non-cancer pain.
- meet DSM-5 criteria for a diagnosis of major depressive disorder
- have access to the internet, email, and telephone
- can commit to the demands and timelines of the trial.
- Given high comorbidity in this population, patients with sleep disturbance or comorbid anxiety will also be eligible to participate.
Exclusion Criteria:
- diagnosis of cognitive impairment (e.g., dementia)
- active suicidal ideation
- severe psychopathology (e.g., schizophrenia)
- unable to sign a safety contract for the duration of the trial
- concurrent participation in psychotherapy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: internet delivered cognitive behavioural therapy (iCBT)
The intervention comprises 7 weekly online modules available through Therapist Assisted Online (TAO), including: 1) psychoeducation about chronic pain and depression; 2) thoughts and feelings; 3) understanding stress and relaxation; 4) unhealthy and healthy thoughts; 5) layers of thinking; 6) core beliefs; and 7) relationship, lifestyle, problem solving, and relapse prevention.
Online content is supplemented with weekly coaching sessions performed via video-conference with doctoral students of Clinical Psychology.
|
The intervention comprises 7 weekly online modules available through Therapist Assisted Online (TAO), including: 1) psychoeducation about chronic pain and depression; 2) thoughts and feelings; 3) understanding stress and relaxation; 4) unhealthy and healthy thoughts; 5) layers of thinking; 6) core beliefs; and 7) relationship, lifestyle, problem solving, and relapse prevention.
Online content is supplemented with weekly coaching sessions performed via video-conference with doctoral students of Clinical Psychology.
|
EXPERIMENTAL: online delivered acceptance and commitment therapy (iACT)
The intervention comprises 7 weekly online modules available through Therapist Assisted Online (TAO), including: 1) psychoeducation about chronic pain and depression; 2) introduction to ACT; 3) cognitive fusion and defusion; 4) thinking mind versus observing mind & acceptance; 5) mindfulness; 6) values; and 7) taking action.
Online content is supplemented with weekly coaching sessions performed via video-conference with doctoral students of Clinical Psychology.
|
The intervention comprises 7 weekly online modules available through Therapist Assisted Online (TAO), including: 1) psychoeducation about chronic pain and depression; 2) introduction to ACT; 3) cognitive fusion and defusion; 4) thinking mind versus observing mind & acceptance; 5) mindfulness; 6) values; and 7) taking action.
Online content is supplemented with weekly coaching sessions performed via video-conference with doctoral students of Clinical Psychology.
|
PLACEBO_COMPARATOR: Attention Control (AC)
Patients in the control condition will be given access online psychoeducation about depression and chronic pain.
They will be provided weekly phone calls to query symptoms and well-being.
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1-module of psychoeducation about chronic pain and major depression.
Weekly contact to complete measures of symptomatology and well-being.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Screening and Consent Rates
Time Frame: Through study completion, up to 2-years
|
The number of patients with CNCP and suspected major depression who are referred for screening will be recorded.
Eligibility rate will be calculated as the number of patients who meet full inclusion criteria divided by the number of patients referred for screening.
Number of patients declining referral for screening and reasons for exclusion will be documented.
Consent rate will be calculated by dividing the number of patients who consent to undergoing randomization by the number who met full inclusion criteria.
|
Through study completion, up to 2-years
|
Change in symptoms of depression measured using the Patient Health Questionnaire - 9 (PHQ-9)
Time Frame: Change from baseline to end of treatment (i.e., week 8).
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Change in symptoms of depression as measured using the PHQ-9 from baseline to post-intervention.
Scores range from 0-27 with higher scores reflecting greater symptoms of depressed mood.
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Change from baseline to end of treatment (i.e., week 8).
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Adherence to intervention measured as frequency of visits to online modules.
Time Frame: End of treatment (i.e., week 8)
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Intervention adherence will be measured using data recorded by Therapist Assisted Online (TAO) program and include: 1) frequency of visits to TAO modules throughout weeks 1 to 8.
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End of treatment (i.e., week 8)
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Perceived acceptability of treatment measured using qualitative interviews
Time Frame: Completion of the intervention (i.e., week 8)
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Acceptability data will be collected using semi-structured interviews with patients.
Open ended questions will be asked to ascertain the following: 1) acceptability of the delivered intervention; 2) perceived value, benefits, harms and unintended consequences of the delivered intervention; 3) perceived need for refinement of the delivered intervention.
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Completion of the intervention (i.e., week 8)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in physical function measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI-SF)
Time Frame: Baseline, 4-weeks, and post-intervention (i.e., week 8)
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Change in pain interference between baseline and post-intervention will be measured using the Brief Pain Inventory - Short Form (BPI-SF).
Pain interference is measured s the average degree to which pain impacts seven daily activities (e.g., activity, work, sleep).
Scores range from 0 to 10 with higher scores reflecting greater pain-related interference.
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Baseline, 4-weeks, and post-intervention (i.e., week 8)
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Change in emotion function measured using the Depression, Anxiety Stress Scale - 21 (DASS-21).
Time Frame: Baseline and through study completion, an average of 8-weeks.
|
Change in depression, anxiety and stress between baseline and post-intervention measured using the Depression, Anxiety Stress Scale - 21 (DASS-21).
The DASS is a 21-item Likert scale with questions ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time).
The 21 questions are divided into three scales, each comprising of 7 questions: depression, anxiety, and stress.
Scores for each subscale range between 0 and 21 with higher scores reflecting greater levels of depression, anxiety, and stress.
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Baseline and through study completion, an average of 8-weeks.
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Change in pain severity will be measured using the pain severity composite scale of the Brief Pain Inventory - Short Form (BPI-SF)
Time Frame: Baseline and through study completion, an average of 8-weeks.
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Change in pain severity between baseline and post-intervention will be measured using the pain severity composite of the Brief Pain Inventory - Short Form (BPI-SF).
Pain severity is measured using the average rating of pain made across the previous 24-hour period (e.g., average pain, worst pain, least pain).
Scores range from 0 to 10 with higher scores reflecting greater pain severity.
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Baseline and through study completion, an average of 8-weeks.
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Change in psychological flexibility measured using the Multidimensional Psychological Flexibility Inventory (MPFI).
Time Frame: Baseline and through study completion, an average of 8-weeks.
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Change in psychological flexibility between baseline and post-intervention measured using the Multidimensional Psychological Flexibility Inventory (MPFI).
The MPFI is a 60-item scale measuring 6 dimensions of psychological flexibility and 6 dimensions of psychological inflexibility as posited by the Hexaflex model.
Each item is rated on a 6-point scale ranging from 1 (never or never true) to 6 (always or always true).
Measures of psychological flexibility and inflexibility are calculated as the average score across the subscales representing each dimension.
Scores range from 1 to 6 with higher scores representing higher levels of the dimensions being assessed.
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Baseline and through study completion, an average of 8-weeks.
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Mediators of change for cognitive behavioural therapy measured using change in the cognitive behavioural therapy skills questionnaire.
Time Frame: Baseline and through study completion, an average of 8-weeks.
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Change in cognitive behavioural therapy (CBT) skill utilization among patients allocated to the CBT group will be measured among patients assigned to the CBT group using the CBT skills questionnaire.
The CBT skills questionnaire is a 16-item self-report measure that assesses the client's frequency and performance of CBT utilization.
It is a 5-point Likert scale ranging from 1 ("I don't do this") to 5 ("I always do this").
Higher scores reflect greater utilization of CBT skills.
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Baseline and through study completion, an average of 8-weeks.
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Mediators of change for acceptance and commitment therapy measured using change in the acceptance and action questionnaire.
Time Frame: Baseline and through study completion, an average of 8-weeks.
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Change in acceptance of chronic pain will be measured among patients assigned to the acceptance and commitment therapy (ACT) group using the Acceptance and Action Questionnaire (AAQ-II).
The AAQ-II is a 7-item self-report measure.
Patients rate how true statements are to them on a scale of 1 (never true) to 7 (always true).
Score ranges from 7-49, with higher scores reflecting less acceptance and commitment.
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Baseline and through study completion, an average of 8-weeks.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 10, 2019
Primary Completion (ACTUAL)
July 1, 2021
Study Completion (ACTUAL)
July 1, 2021
Study Registration Dates
First Submitted
June 17, 2019
First Submitted That Met QC Criteria
July 3, 2019
First Posted (ACTUAL)
July 5, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 16, 2021
Last Update Submitted That Met QC Criteria
September 15, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HREB2018.275
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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