Psychological DistressISACNCT06766526
Internet-based Support for Adjustment to Prostate Cancer
A study testing Internet-based cognitive behavioral therapy and Non-directive support in people with Psychological Distress and Depression - Major Depressive Disorder, run by Linkoeping University at 1 site in Sweden.
Trial summary
The study aims to study the efficacy of internet-based cognitive behavior therapy (ICBT) in reducing subjective distress and comorbid psychiatric symptoms in men diagnosed with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Psychological Distress, Depression - Major Depressive Disorder, Insomnia
- What is being tested?
- Internet-based cognitive behavioral therapy and Non-directive support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSweden
- Study dates
- 5 Jan 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjectively reported psychological symptoms and problems that have come about after a prostate cancer diagnosis.
- A sum score above 19 on the primary outcome measure (Kessler-10).
- An age of 18 or older.
- Ability to speak, read, and write Swedish.
- Access to a computer/laptop/tablet/smartphone and internet access.
- Sufficient computer profiency to be able to use the treatment platform.
Who cannot join
- Planned medical treatment or planned change in medication related to the prostate cancer during the treatment period.
- Recently finished (within the past six months) medical treatment for prostate cancer.
- Severe psychiatric or somatic conditions that impedes participation in the study.
- Ongoing substance use problems.
- Acute suicidality.
- Other ongoing psychological treatment.
- Psychopharmaceutic treatment that has been changed within the past month or with planned changes during the treatment phase.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anton Käll, Ph.D. contact
Sweden1 site, 1 recruiting
- Recruiting
Department of Behavioral Sciences and Learning
Linköping, 58183
Gerhard Andersson, Ph.D., +46-13285840, gerhard.andersson@liu.se
Gerhard Andersson, Ph.D.
About this study
Official title: Internet-based Support for Adjustment to Prostate Cancer (ISAC) - A Randomized Controlled Trial of ICBT for Distress Related to Prostate Cancer
The study aims to study the efficacy of internet-based cognitive behavior therapy (ICBT) in reducing subjective distress and comorbid psychiatric symptoms in men diagnosed with prostate cancer. Participants who have been diagnosed with prostate cancer and are currently not undergoing or scheduled to undergo medical treatment will be recruited. Once recruited, they will be randomized to receive either a tailored, eight-week long ICBT intervention or an attention control group. Both group receive weekly support by a trained therapist.
Read the detailed description
Men diagnosed with prostate cancer frequently suffer from a wide range of psychological problems that can be traced to their disorder. Examples include depressed mood and worry regarding the prognosis and/or cancer recurrence. Psychological treatments can be used for helping cancer patients deal with this kind of distress, but frequently only targets one kind of symptoms.
This study investigates a tailored approach to providing help for men diagnosed with prostate cancer. Participants randomized to the treatment condition will receive an eight week ICBT intervention which is tailored to the problem profile of the participant in question. The treatment will last eight weeks and participants will receive weekly support and feedback from a therapist. Participants randomized to the control condition will receive weekly therapist support, but not access to the treatment modules. The primary outcome of interest is psychological distress, and other health-related outcomes will be measured as well. Participants will be recruited in Sweden with a nationwide recruitment.
- Conditions
- Psychological Distress, Depression - Major Depressive Disorder, Insomnia, Anxiety, Prostate Cancer
- Being tested
- Internet-based cognitive behavioral therapy, Non-directive support
- Keywords
- Psychological distress, Prostate cancer, Cancer, ICBT, Cognitive behavior therapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based cognitive behavioral therapyBehavioural
An eight week ICBT treatment. The treatment is modular and tailored to the problem profile of the participant. One module will be administered every week during the treatment phase.
Non-directive supportBehavioural
Participants randomized to this condition will receive weekly support and contact with a therapist via the treatment platform. They will not have access to the treatment modules during the treatment phase.
| Study group | Role | What they receive |
|---|---|---|
| Tailored ICBT | Experimental | An eight week long ICBT treatment that is tailored to the problem profile of the participant. The treatment is modular, with one module being administered per week of the treatment. Receives: Behavioral: Internet-based cognitive behavioral therapy |
| Non-directive support | Active comparator | The control group will receive weekly support via contact with a therapist, without receiving access to the treatment modules. Receives: Behavioral: Non-directive support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kessler-10 (K10)
Measure of psychological distress. Consists of 10 items. Higher scores indicate greater psychological distress. Scores can range between 10 and 50.
Measured: At pretreatment, weekly during the treatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
Secondary outcomes (6)
Fear of Cancer Recurrence Inventory, short form (FCRI)
Measure of fear of the cancer recurring and/or spreading. Consists of 9 items. Higher scores indicate greater fear/anxiety levels. Scores can range between 0 and 36.
Measured: At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
Generalized Anxiety Disorder-7 item scale (GAD-7)
Measure of symptoms of generalized anxiety disorder. Consists of seven items. Higher scores indicate greater anxiety. Scores can range between 0 and 21.
Measured: At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
Insomnia Severity Index (ISI)
Measure of insomnia and sleep related-difficulties. Consists of seven items. Higher scores indicate greater sleep related-difficulties. Scores can range from 0 to 28.
Measured: At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
Brunnsviken Brief Quality of Life Scale (BBQ)
Measure of quality of life. Consists of 12 items. Higher scores indicate a greater quality of life. Scores can range between 0 and 96.
Measured: At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)
Measure of health-related quality of life. Consists of 30 items and three main subscales which each will serve as an outcome: Global health status, Functional status, and Symptom status. Higher scores indicate a greater health status within the domain. Scores can range between 0 and 100.
Measured: At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
The Illness Cognition Questionnaire (ICQ)
Measure of cognitions about the illness (in this case prostate cancer). Consists of 18 items. Analyzed separately as three subscales: Acceptance, Perceived benefits, and Helplessness. Greater scores indicate greater acceptance, more perceived benefits, and greater helplessness, respectively. Will also be used as mediators in a mediation analysis with the rate of change in subscale sum scores used as mediators. Sum scores for each subscale can range between 6 and 24.
Measured: At pretreatment, weekly during the treatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start5 Jan 2025
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After recruitment finished, participants will be randomized to either tailored ICBT treatment or a control condition.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- University Hospital, Linkoeping
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
- Investigators
- Gerhard Andersson, pHD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766526
- Sponsor's protocol ID
- ISAC
- Acronym
- ISAC
- Status last verified
- Feb 2025
- First submitted
- 2 Jan 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Support for Adjustment to Prostate Cancer (ISAC) - A Randomized Controlled Trial of ICBT for Distress Related to Prostate Cancer
- ClinicalTrials.gov ID
- NCT06766526
- Acronym / sponsor ID
- ISAC / ISAC
- Conditions
- Psychological Distress, Depression - Major Depressive Disorder, Insomnia, Anxiety, Prostate Cancer
- Keywords
- Psychological distress, Prostate cancer, Cancer, ICBT, Cognitive behavior therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- University Hospital, Linkoeping
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to study the efficacy of internet-based cognitive behavior therapy (ICBT) in reducing subjective distress and comorbid psychiatric symptoms in men diagnosed with prostate cancer. Participants who have been diagnosed with prostate cancer and are currently not undergoing or scheduled to undergo medical treatment will be recruited. Once recruited, they will be randomized to receive either a tailored, eight-week long ICBT intervention or an attention control group. Both group receive weekly support by a trained therapist.
Detailed description
Men diagnosed with prostate cancer frequently suffer from a wide range of psychological problems that can be traced to their disorder. Examples include depressed mood and worry regarding the prognosis and/or cancer recurrence. Psychological treatments can be used for helping cancer patients deal with this kind of distress, but frequently only targets one kind of symptoms.
This study investigates a tailored approach to providing help for men diagnosed with prostate cancer. Participants randomized to the treatment condition will receive an eight week ICBT intervention which is tailored to the problem profile of the participant in question. The treatment will last eight weeks and participants will receive weekly support and feedback from a therapist. Participants randomized to the control condition will receive weekly therapist support, but not access to the treatment modules. The primary outcome of interest is psychological distress, and other health-related outcomes will be measured as well. Participants will be recruited in Sweden with a nationwide recruitment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After recruitment finished, participants will be randomized to either tailored ICBT treatment or a control condition.
| Arm | Type | Receives |
|---|---|---|
| Tailored ICBT | Experimental | Behavioral: Internet-based cognitive behavioral therapyAn eight week long ICBT treatment that is tailored to the problem profile of the participant. The treatment is modular, with one module being administered per week of the treatment. |
| Non-directive support | Active comparator | Behavioral: Non-directive supportThe control group will receive weekly support via contact with a therapist, without receiving access to the treatment modules. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjectively reported psychological symptoms and problems that have come about after a prostate cancer diagnosis.
- A sum score above 19 on the primary outcome measure (Kessler-10).
- An age of 18 or older.
- Ability to speak, read, and write Swedish.
- Access to a computer/laptop/tablet/smartphone and internet access.
Key exclusion criteria (7 listed)
- Planned medical treatment or planned change in medication related to the prostate cancer during the treatment period.
- Recently finished (within the past six months) medical treatment for prostate cancer.
- Severe psychiatric or somatic conditions that impedes participation in the study.
- Ongoing substance use problems.
- Acute suicidality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based cognitive behavioral therapyAn eight week ICBT treatment. The treatment is modular and tailored to the problem profile of the participant. One module will be administered every week during the treatment phase. | Behavioural | Tailored ICBT |
| Non-directive supportParticipants randomized to this condition will receive weekly support and contact with a therapist via the treatment platform. They will not have access to the treatment modules during the treatment phase. | Behavioural | Non-directive support |
Primary outcome
Kessler-10 (K10)
Time frame: At pretreatment, weekly during the treatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
Measure of psychological distress. Consists of 10 items. Higher scores indicate greater psychological distress. Scores can range between 10 and 50.
6 secondary outcomes
Fear of Cancer Recurrence Inventory, short form (FCRI)
Time frame: At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
Generalized Anxiety Disorder-7 item scale (GAD-7)
Time frame: At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
Insomnia Severity Index (ISI)
Time frame: At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
Brunnsviken Brief Quality of Life Scale (BBQ)
Time frame: At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)
Time frame: At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
The Illness Cognition Questionnaire (ICQ)
Time frame: At pretreatment, weekly during the treatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Website used for the treatment.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anton Käll, Ph.D. contact
Gerhard Andersson, pHD principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based cognitive behavioral therapy and Non-directive support in people with Psychological Distress and Depression - Major Depressive Disorder, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gerhard Andersson, Ph.D. (+46-13285840, gerhard.andersson@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kessler-10 (K10) (time frame: At pretreatment, weekly during the treatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.