Back to resultsThe Internet Therapy for Depression Trial (INTEREST)
Primary Purpose
Chronic Pain, Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
internet delivered cognitive behavioural therapy (iCBT)
online delivered acceptance and commitment therapy (iACT)
Attention Control (AC)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Chronic non-cancer pain, Major depression, Internet therapies, Cognitive behaviour therapy, Acceptance and commitment therapy
Eligibility Criteria
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.
Sites / Locations
- Memorial University of Newfoundland
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
internet delivered cognitive behavioural therapy (iCBT)
online delivered acceptance and commitment therapy (iACT)
Attention Control (AC)
Arm Description
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) 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.
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.
Outcomes
Primary Outcome Measures
Screening and Consent Rates
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.
Change in symptoms of depression measured using the Patient Health Questionnaire - 9 (PHQ-9)
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.
Adherence to intervention measured as frequency of visits to online modules.
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.
Perceived acceptability of treatment measured using qualitative interviews
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.
Secondary Outcome Measures
Change in physical function measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI-SF)
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.
Change in emotion function measured using the Depression, Anxiety Stress Scale - 21 (DASS-21).
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.
Change in pain severity will be measured using the pain severity composite scale of the Brief Pain Inventory - Short Form (BPI-SF)
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.
Change in psychological flexibility measured using the Multidimensional Psychological Flexibility Inventory (MPFI).
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.
Mediators of change for cognitive behavioural therapy measured using change in the cognitive behavioural therapy skills questionnaire.
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.
Mediators of change for acceptance and commitment therapy measured using change in the acceptance and action questionnaire.
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.
Full Information
NCT ID
NCT04009135
First Posted
June 17, 2019
Last Updated
September 15, 2021
Sponsor
Memorial University of Newfoundland
1. Study Identification
Unique Protocol Identification Number
NCT04009135
Brief Title
The Internet Therapy for Depression Trial
Acronym
INTEREST
Official Title
The Internet Therapy for Depression Trial (INTEREST): A Doubly-randomized, Patient-preference, Controlled Feasibility Trial Comparing iACT, iCBT, and Attention Control
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 10, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Memorial University of Newfoundland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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."
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Major Depressive Disorder
Keywords
Chronic non-cancer pain, Major depression, Internet therapies, Cognitive behaviour therapy, Acceptance and commitment therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Doubly-randomized, patient-preference trial with two active study interventions and one control.
Masking
InvestigatorOutcomes Assessor
Masking Description
A research assistant not affiliated with the study will use Research Randomizer (http://www.randomizer.org/) to generate lists of randomly sequenced numbers to allocate patients to trial arm. To reduce biases and expectation effects, the research assistant will not be aware of what condition the patients are allocated when conducting baseline assessments and a research assistant not affiliated with the research will complete outcome assessments without being aware of allocation. Interventionists will be aware of which group patients are allocated to, as will patients.
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
internet delivered cognitive behavioural therapy (iCBT)
Arm Type
Experimental
Arm Description
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.
Arm Title
online delivered acceptance and commitment therapy (iACT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Control (AC)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
internet delivered cognitive behavioural therapy (iCBT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
online delivered acceptance and commitment therapy (iACT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Attention Control (AC)
Intervention Description
1-module of psychoeducation about chronic pain and major depression. Weekly contact to complete measures of symptomatology and well-being.
Primary Outcome Measure Information:
Title
Screening and Consent Rates
Description
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.
Time Frame
Through study completion, up to 2-years
Title
Change in symptoms of depression measured using the Patient Health Questionnaire - 9 (PHQ-9)
Description
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.
Time Frame
Change from baseline to end of treatment (i.e., week 8).
Title
Adherence to intervention measured as frequency of visits to online modules.
Description
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.
Time Frame
End of treatment (i.e., week 8)
Title
Perceived acceptability of treatment measured using qualitative interviews
Description
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.
Time Frame
Completion of the intervention (i.e., week 8)
Secondary Outcome Measure Information:
Title
Change in physical function measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI-SF)
Description
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.
Time Frame
Baseline, 4-weeks, and post-intervention (i.e., week 8)
Title
Change in emotion function measured using the Depression, Anxiety Stress Scale - 21 (DASS-21).
Description
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.
Time Frame
Baseline and through study completion, an average of 8-weeks.
Title
Change in pain severity will be measured using the pain severity composite scale of the Brief Pain Inventory - Short Form (BPI-SF)
Description
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.
Time Frame
Baseline and through study completion, an average of 8-weeks.
Title
Change in psychological flexibility measured using the Multidimensional Psychological Flexibility Inventory (MPFI).
Description
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.
Time Frame
Baseline and through study completion, an average of 8-weeks.
Title
Mediators of change for cognitive behavioural therapy measured using change in the cognitive behavioural therapy skills questionnaire.
Description
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.
Time Frame
Baseline and through study completion, an average of 8-weeks.
Title
Mediators of change for acceptance and commitment therapy measured using change in the acceptance and action questionnaire.
Description
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.
Time Frame
Baseline and through study completion, an average of 8-weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Memorial University of Newfoundland
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B3X9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32114466
Citation
Bell LV, Cornish P, Flusk D, Garland SN, Rash JA. The INternet ThERapy for deprESsion Trial (INTEREST): protocol for a patient-preference, randomised controlled feasibility trial comparing iACT, iCBT and attention control among individuals with comorbid chronic pain and depression. BMJ Open. 2020 Feb 28;10(2):e033350. doi: 10.1136/bmjopen-2019-033350.
Results Reference
derived
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The Internet Therapy for Depression Trial
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