Research Findings — Session Content Evidence Base¶
Techniques here are operationalised as sessions in
sessions-backlog.csv(experiment, reframe, sentenceCompletion, valuesSort rows). This doc is retained as the evidence/grading reference behind those rows.
Evidence base for Naluma's session components, synthesized from Neon DB vault notes (144 relevant notes), PubMed source items (25 relevant items), web research (7 competitor/programme analyses), and 5 deep-read PubMed articles. Research conducted April 2026.
1. Validated Digital Tinnitus Therapy Programmes¶
Four validated digital programmes provide structural benchmarks:
| Programme | Structure | Duration | Approach | Key Techniques | Evidence |
|---|---|---|---|---|---|
| Beukes iCBT | 22 modules + worksheets, audiologist-guided | 8 weeks | CBT | Psychoeducation, cognitive restructuring, relaxation, attention training, sleep hygiene, behavioural activation, mindfulness module | Multiple RCTs; effects maintained at 1+ year. JAMA noninferiority trial vs face-to-face (PMC8642102) |
| Kalmeda (DiGA) | 5 levels u00d7 9 steps | 9 months (3 mo basics + 7 mo deepening) | CBT + ACT + Zu00fcrcher Ressourcen Modell | L1u20132: attention redirection, relaxation. L3u20135: mindfulness, acceptance, self-efficacy. Nature sounds, guided meditation | RCT: Cohen d=1.38 at 9 months; 80% exceeded MCID (PMC10484427, PMC11888023) |
| Tinnibot/Timibot | Chatbot-based, 10 min/day | 8 weeks (hybrid: + 4u00d730min video consults) | CBT + MBCT | Thought challenging, behaviour activation, relaxation, mindfulness, acceptance, gratitude, soundscapes | 42% (app-only) vs 64% (hybrid) clinically significant improvement; both 64% at 2-month follow-up |
| iCBT4Tinnitus | 7 modules, audiologist-delivered | Self-paced | CBT (NHS model) | Assessment/4C framework, behavioural experiments, thought challenging, thought diary, positive psychology | 97% acceptability rating (median 10/10); 52% clinically significant improvement |
Key insight: Kalmeda's 9-month programme validates our 12-week core + maintenance approach. The iCBT4Tinnitus 4C framework (Classify, Cope, Control, Communicate) is a novel structuring device worth considering.
2. The 25 Active Components of CBT for Tinnitus¶
A scoping review (vault note #586) decomposed all published tinnitus CBT programmes into 25 constituent components. This is the most comprehensive inventory of what "CBT for tinnitus" actually consists of:
| Category | Components | Naluma Coverage |
|---|---|---|
| Cognitive | Psychoeducation, cognitive restructuring, thought challenging, thought monitoring/diary | Covered in current plan |
| Behavioural | Behavioural activation, graded exposure, behavioural experiments, sleep management, attention training | Mostly covered; behavioural experiments and graded exposure are NEW additions needed |
| Third-wave | Acceptance, defusion, mindfulness, values clarification, committed action | Covered (ACT components) |
| Relaxation | PMR, breathing exercises, autogenic training, imagery/visualisation | PMR and breathing covered; autogenic training and guided imagery are NEW additions needed |
| Other | Goal setting, relapse prevention, positive psychology, motivational enhancement, self-efficacy building | Relapse prevention covered; positive psychology, motivational enhancement, and self-efficacy exercises are NEW additions needed |
3. New Techniques Discovered (Not in Original Component List)¶
3a. Behavioural Experiments¶
Testing predictions about tinnitus in real life. Rated 9/10 effectiveness by patients in the 2025 Tonndorf lecture (PMC12109689). Example: "If I go out without earplugs, I will panic" u2192 test it u2192 discover the prediction was wrong.
App implementation: Chip-guided prediction u2192 real-world test u2192 post-experiment reflection.
3b. Diary of Thoughts and Feelings¶
Self-monitoring automatic thoughts. Rated 9/10 effectiveness. The iCBT4Tinnitus programme includes this as a core module.
App implementation: Structured thought record via chips (situation u2192 thought u2192 emotion u2192 alternative thought).
3c. Autogenic Training¶
Self-suggestion technique for deep relaxation ("my arms are heavy and warm"). Described alongside PMR in vault note #432 as a core relaxation pillar.
App implementation: Audio-guided 5u201310 min sessions with body-part-by-body-part script.
3d. Guided Imagery¶
Visualisation exercises for relaxation. Part of the Beukes programme's relaxation module.
App implementation: Audio-guided visualisation ("imagine a calm beach...") with tinnitus-adapted script.
3e. Gratitude Exercises¶
From Tinnibot's MBCT component. Acknowledging positive aspects of daily life despite tinnitus.
App implementation: Evening reflection chip exercise ("Name three things that went well today").
3f. Positive Psychology Interventions¶
From iCBT4Tinnitus module 6. Strengths-based approaches beyond deficit-focused CBT.
App implementation: "Character strengths" identification + daily strengths practice.
3g. Self-Efficacy Building¶
From Kalmeda's Level 5. Building confidence in ability to manage tinnitus independently.
App implementation: Mastery tracking, skill review sessions, "I can handle this" reframing.
3h. The 4C Framework¶
From iCBT4Tinnitus: Classify (understand your tinnitus), Cope (develop strategies), Control (what you can influence), Communicate (tell others about your experience).
App implementation: Could serve as an alternative structuring device for the programme phases.
3i. Graded Exposure¶
Gradual exposure to avoided situations (noisy environments, silence, social events). Standard CBT component identified in the 25-component review.
App implementation: Exposure hierarchy via chips u2192 real-world exposure u2192 post-exposure reflection.
3j. Motivational Enhancement¶
From the Kalmeda Zu00fcrcher Ressourcen Modell. Building intrinsic motivation for therapy engagement.
App implementation: Values-linked motivation exercises in early programme stages.
3k. Fractal Tone Sound Therapy¶
Recursive algorithm-generated therapeutic sounds that never repeat (vault note on fractal tones). Addresses listener fatigue with broadband noise.
App implementation: Fractal tone option in sound library alongside nature sounds and noise colours.
4. Technique Refinements (Existing Components That Need More Variants)¶
4a. Relaxation Training u2192 4 Distinct Techniques¶
Vault note #432 establishes relaxation as "one of the three core pillars" with 15u201330 min daily practice. Should be broken into:
- PMR (progressive muscle relaxation) u2014 already planned
- Autogenic training u2014 NEW
- Diaphragmatic breathing u2014 already planned
- Guided imagery/visualisation u2014 NEW
4b. Cognitive Restructuring u2192 3 Progressive Exercises¶
- Thought monitoring (identify automatic thoughts) u2014 NEW standalone component
- Thought challenging (evaluate evidence for/against) u2014 already planned
- Balanced reappraisal (generate alternative thought) u2014 already planned
4c. Sound Therapy u2192 Multiple Sound Types¶
Vault notes on sound therapy reveal specific evidence for:
- White noise u2014 standard but risk of overuse (vault #591: "cobra effect")
- Pink noise u2014 uniquely improves speech-in-noise (vault #375)
- Nature sounds u2014 preferred by most users
- Fractal tones u2014 non-habituating, musically structured (vault #183u2013184)
- Notched music u2014 personalised to tinnitus frequency, reduces loudness (vault #322u2013323, #345)
- Amplitude-modulated tones u2014 outperform broadband noise (vault #45)
4d. Sleep Exercises u2192 CBT-I Specific Components¶
Vault note #90: CBT-I achieves 80% response rate for tinnitus insomnia. Should include:
- Sleep diary u2014 NEW
- Stimulus control (bed = sleep only) u2014 NEW
- Sleep restriction u2014 NEW
- Sleep hygiene education u2014 already planned
- Bedtime sound enrichment u2014 already planned
5. Programme Structure Insights¶
5a. Clinical Sequencing (Reinforced by Research)¶
The Retention Architecture's sequencing is strongly validated:
- Psychoeducation first u2014 TRT protocol mandates counselling before sound therapy (PMC8632517: "operating without its anchor")
- Sleep rescue immediately u2014 vault #342: "perceived severity driven by sleep disruption, not sound"; vault #405: sleep mediates 28% of tinnitus-to-anxiety pathway
- Relaxation early u2014 vault #432: daily practice for neuroplastic change
- CBT cognitive work mid-programme u2014 aligned with Beukes weeks 5u20136
- ACT late u2014 vault #8: ACT outperforms TRT at 18 months; best after CBT foundation
5b. Counselling Is the Active Ingredient¶
TRT RCT finding (PMC8632517): counselling alone achieved >30% tinnitus impact reduction regardless of whether sound generators were real or placebo. Vault note #344: Rogerian person-centred counselling matches directive TRT counselling. Implication: the empathic, validating tone of Naluma's chat is as important as the specific techniques.
5c. Combination Therapy via Compensation¶
Vault note #136 (N=461 RCT): combination treatments beat single treatments via compensation (one component offsets another's non-response), not synergy. Implication: the blended CBT+ACT+TRT approach ensures different users find their best-responding component.
5d. Digital Delivery Is Validated¶
- iCBT matches face-to-face (JAMA 2018, vault #601)
- Smartphone CBT benefits compound over 9 months (vault #4)
- Effects durable at 6+ years (pmid:41854598)
- BUT dropout is high (21u201351%) u2014 engagement design is critical (vault #599)
6. Gaps Identified¶
| Gap | Source | Action |
|---|---|---|
| No autogenic training component | Vault #432 | Add as relaxation component |
| No guided imagery component | Beukes programme | Add as relaxation component |
| No behavioural experiments | iCBT4Tinnitus, PMC12109689 (rated 9/10) | Add as CBT practice component |
| No thought diary/monitoring | iCBT4Tinnitus, PMC12109689 (rated 9/10) | Add as CBT practice component |
| No gratitude exercises | Tinnibot MBCT | Add as ACT/reflection component |
| No positive psychology module | iCBT4Tinnitus module 6 | Add as late-programme component |
| No CBT-I specific exercises (sleep diary, stimulus control, sleep restriction) | Vault #90 (80% response rate) | Add 3 CBT-I components |
| No graded exposure exercises | 25-component review | Add as behavioural component |
| No self-efficacy tracking | Kalmeda Level 5 | Add as consolidation component |
| No fractal tone sound option | Vault #183u2013184 | Consider for sound library |
7. Key Source References¶
Primary Programme References¶
- Beukes iCBT: PMC8642102, JAMA noninferiority trial
- Kalmeda RCT: PMC10484427, PMC11888023
- Tinnibot: Frontiers in Audiology 2023 (chatbot-based iCBT)
- iCBT4Tinnitus: 7-module NHS-adapted programme
Evidence Reviews¶
- 25 CBT components: Vault note #586 (scoping review)
- Cochrane CBT: PMC3936550 (moderate-certainty evidence for QoL)
- 2025 Tonndorf lecture: PMC12109689 (patient-rated technique effectiveness)
- TRT counselling protocol: PMC8632517 (33-point checklist, mixing-point concept)
Technique-Specific Evidence¶
- CBT-I for tinnitus insomnia: Vault #90 (80% response rate, 66.7% ISI improvement)
- ACT vs TRT: Vault #8 (54.5% vs 20% reliable improvement; 18-month superiority)
- Relaxation catalogue: Vault #432 (PMR, autogenic training, breathing, yoga)
- Sound therapy + CBT: Vault #422 (sound therapy only works combined with behavioural therapy)
- White noise overuse risk: Vault #591 ("cobra effect" from excessive exposure)
Vault Notes u2014 Highest Priority for Session Design¶
- #586 u2014 25 Active Therapeutic Components of CBT for Tinnitus
- #432 u2014 PMR, Autogenic Training, Breathing, Yoga catalogue
- #90 u2014 CBT-I for tinnitus insomnia (80% response)
- #8, #10, #11 u2014 ACT evidence base
- #422 u2014 Sound therapy only works with behavioural therapy
- #591 u2014 White noise overuse warning
- #144, #166, #167 u2014 EMA/daily tracking evidence
- #542 u2014 Fear mediates CBT benefit
- #344 u2014 Empathic counselling = active ingredient